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Clinical Trial Essay
Clinical trials are often designed to test new biomedical or behavioral interventions such as new treatments/drugs, prevention strategies, screening
programs, diagnostic tests, and educational models. The rapid increase in the costs of conducting clinical trials has made the efficient design of
clinical trials more important in recent years. For example, a new report published by Tufts Center for the Study of Drug Development (CSDD)
expresses that the costs of new drug development which is one of the wide applications of clinical trials have been pegged at $2.558 billion, with a
145% increase over an estimate made in 2003 [9].
2.Clinical trial classification
Clinical trials are divided into two main classes based on how participants are allocated to different interventions: randomized and non–randomized
controlled trials [21]. Non–randomized trials (also called quasi–experiment) assign participants to the treatments, procedures, or interventions by
methods that are not random. These trials are used when randomization is impractical and/or unethical. They are typically easier to set up than
randomized trials which need random assignment of subjects. Lack of random assignment in ... Show more content on Helpwriting.net ...
In the simplest case, a 2x2 factorial trial design generates four sets of data to analyze based on whether subjects receive interventions A only, B only,
both A and B, or neither A or B. Thus, the factorial designs can evaluate not only the effects of each intervention but also the interaction that may exist
between two interventions (or treatments). For this reason, this trial design can be viewed as an efficient way to conduct two trials in one. However, it
is not recommended when comparing the two interventions to each other is considered as a primary purpose
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Symptoms And Treatment Of Clinical Trials
Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical
procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe.
Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. (NIH.gov, 2016). There are
different types of clinical trials. –Natural history studies provide valuable information about how disease and health progress. –Prevention trials look
for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Better approaches may... Show
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Phase II trials: The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further
evaluate its safety. Phase III trials: The experimental drug or treatment is administered to large groups of people (1000–3000) to confirm its
effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or
treatment to be used safely. Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking
more information about a drug or treatment's risk, benefits, and optimal use (NIH.gov, 2016). Migraine is a common episodic headache disorder often
associated with an impaired quality of life. Preventive, prophylactic treatment of migraine should be considered for patients who are significantly
disabled by attacks and unresponsive to acute rescue treatment, and for those who respond to acute treatment but experience frequent attacks, as there
is an increased likelihood of drug induced (rebound) headache in this population. An example of a prevention trial is treating a group of patients with
migraines with 100mg/day topiramate in double–blind, placebo–controlled trials (Silberstein, 2004). Response rates were high, and onset of action
usually occurred within the first month of treatment. Evidence from large, well–conducted,
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The Impact Of Hiring A Crc On Patients, Physicians,...
A Clinical Research Coordinator (CRC) is a research professional working under the immediate direction of a clinical Principal Investigator (PI).
While the PI is primarily responsible for the overall design, execution, and management of the clinical trial, the CRC supports, facilitates, and
coordinates the daily clinical activities and plays a crucial role in the conduct of a clinical study. This business case will highlight the role of Clinical
Research Coordinators and the impact hiring a CRC will have on the success of a clinical trial. Results will be used to determine the viability and
financial feasibility for hiring a clinical research coordinator. The scope of this business case will highlight the impact of hiring a CRC on patients,
physicians, provider sites, and clinical trials. Decision makers will understand the costs and benefits of CRC staffing and will use this guide in their
hiring process.
2.2Opportunity
The current market for clinical research trials is evolving towards increasing productivity in clinical trials. There is a demand for cost–effective, faster,
and more efficient clinical trial processes. Clinician and regulatory agencies are requiring more data from clinical trials, increasing the complexity of
clinical trials. Trends towards complex clinical trials have created a demand for increasing clinical trial staffing. In addition, companies aiming for
more successful clinical trials have had an impact on staffing. Since 2008,
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Clinical Trials Evaluation And Treatment Of Her2...
Tanzir Mortuza
PHAR 7100
Project 2
Clinical Trial Evaluation
Primary Article:
Vogel, Charles L., et al. "Efficacy and safety of trastuzumab as a single agent in first–line treatment of HER2–overexpressing metastatic breast cancer."
Journal of Clinical Oncology 20.3 (2002): 719–726.
1.0 Introduction:
Breast cancer is the most diagnosed cancer in the US for women (http://www.breastcancer.org/symptoms/understand_bc/statistics). Even though the
diagnosis and treatment of this condition has improved dynamically over the past few decades, it is still one of the leading causes of mortality among
the women in USA and all over the world. There are usually four stages of breast cancer (http://www.breastcancer.org/symptoms/understand_bc
/statistics). ... Show more content on Helpwriting.net ...
Around 25–30% of the total breast cancer patients are diagnosed with HER2 gene amplification (Vogel, Charles L., et al, 2002). Patients with HER2
gene overexpression also produces a higher level of protein therefore, the patients with this condition are susceptible to decreased disease free and
shorter overall survival rate(Vogel, Charles L., et al, 2002). The non–targeted cytotoxic chemotherapy has been used as a standard treatment of this
condition. However, there are several side effects for these non–targeted therapies; such as vomiting, nausea, headache, fatigue, diarrhea, dizziness,
anemia, thrombocytopenia, leukemia, anxiety, depression, anorexia and so on(O 'Shaughnessy, Joyce, et al, 2011). Therefore, a lot of patients are
unable to use cytotoxic chemotherapy as a standard treatment. It is necessary to have a safe treatment that can serve the unmet purpose of these patients.
Trastuzumab is a monoclonal antibody that recognizes the p185 site of HER2 (Vogel, Charles L., et al, 2002). As this is a humanized antibody, it
reduces the chances of immunological response in the human body that may occur if a murine antibody was used. At the same time, this humanized
monoclonal antibody initiates the maximum recruitment of patients' endogenous immune system to attack and destroy the overexpressed cells (Vogel,
Charles L., et al, 2002). The efficacy of this therapeutic has been already evaluated with presence of chemotherapy in several clinical
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Evaluation Of A Clinical Trial Essay
1.3Clinical Trials A clinical trial is a prospective study comparing the effect and value of an intervention(s) against a control in human beings
(Friedman & De Mets, 2010). It is an assured way of determining whether an intervention has the hypothesized effect since researchers have control
of most of the cofounders involved in the studies. Each of the participants is followed onward in time from a defined point in time, which is the
baseline for the study. Participants are randomly assigned to the various intervention options to create comparable intervention groups. A protocol is
one of the requirements of a properly designed trial. A protocol, which is an agreement between the investigator, the participant and the scientific
community, provides the background, objectives, design and organization of the trial. This is a document that is prepared way before participants are
enrolled, and remains essentially unchanged unless for minor updates. Any major changes altering the direction of the trial need to be carefully
justified; a rationale behind the changes should be clearly described. In clinical trials, an outcome is defined as a variable intended for comparison
between groups in order to assess the efficacy or harm of an intervention (Chan, 2004). An outcome may be primary or secondary. A primary outcome,
measured at the primary endpoint, is the variable that forms the basis of the study and is predetermined by the investigator at the design stage of the
study. A
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Clinical Trials: A Kantian and Utilitarian Point of View...
The first article is entitled "of mice but not men: problems of randomized clinical trials," is written by Samuel Hellman and Deborah S. Hellman
discusses the issues of randomized medical testing and experiments on patients. The article describes the role of the personal physician and how the
physician can take an ethical or unethical path of treating his/her patients. The relationship between the patient and physician is greatly emphasized
because according to the article trust is very valuable in medicine especially when a patient's life is at risk. A Kantian and a Utilitarian view of
randomized clinical trials are debated but the authors clearly steers towards a Kantian point of view. The author explains how randomized clinical...
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The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine
will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of
evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because
previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed
that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly
informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized
clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why
these trials can be in the best interests for both the patient and society. Two completely different viewpoints of randomized clinical trials are given,
article one is against the idea and article two is for it. Article one argues that when a patient sees a physician; the physician has the duty to provide the
best treatment for that
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The Importance Of Tissue Engineering And Human Clinical...
Tissue engineering has been an opportunity to restore the human condition from wounded to whole through the combination of biological,
biochemical, and biomechanical concepts. Unlike traditional transplantation, tissue engineering and regenerative medicine uses a patient's own cells
to fabricate new tissues which are then grafted back into his or her body. Of course, the goal is to apply the practices in the lab to the general public
and to develop a new and more effective means to treat patients with severe tissue loss and/or organ failure. Each innovation requires a certain series
of steps and regulations, from laboratory study to animal testing to human clinical trials. Unfortunately, a majority of tissue engineering trials fail to
translate from lab to hospital because of a variety of issues, especially during clinical trials. According to Lanza et al., "Over the last decade, we have
seen a number of tissue–engineered products that have either been abandoned following Phase I/II clinical trials, or have failed in Phase III clinical
testing." The relatively high cost of these technologies and the lengthy experimentation lead to the question of how clinical trials are to be funded. For
cases involving Investigational New Drugs (INDs), the U.S. Food and Drug Administration (FDA) allows sponsors of a research project to charge
patients for the administration of investigational products during clinical studies. Traditionally, funding for clinical trials is provided by
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Clinical Trial Eligibility Criteria
Clinical trials are the gold standard of experimental design to examine the effect of a clinical intervention on patients or populations. Recruiting
targeted number of subjects in a timely manner is essential to the success of a clinical trial. Failure to enroll and retain expected number of
participants could result in underpowered study (Page & Persch, 2013). One of the challenge for clinical trial recruitment is the clinical trial eligibility
criteria are mostly written in free text, which cannot be easily interpreted by computer for automatic patient for the clinical trial.
In order to utilize the electronic health record (EHR) system to match a patient to clinical trials, match patients to applicable clinical evidence and
re–use of eligibility criteria from related clinical research studies on similar patients during the design of a new study, several eligibility criteria
knowledge representations were developed(Weng, Tu, Sim, & Richesson, 2010), such as SAGE, Eligibility Rule Grammar and Ontology (EGRO) (Tu
et al., 2011). Analysis of Common Eligibility Features (CEFs) (Boland & Weng, 2013) and clustering of similar eligibility criteria (Hao, Rusanov,
Boland, & Weng, 2014; Luo, Yetisgen
–Yildiz, & Weng, 2011) explored some applications of semantic similarity between clinical trial eligibility criteria.
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It is the opposite of semantic similarity. Matching two clinical trial eligibility criteria can be seen as measuring the semantic distance between the two
eligibility criteria documents. Matching a patient to a clinical trial can be seen as calculating the semantic distance between a clinical trial eligibility
criteria document with a collection of medical documents of a
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Clinical Trials In Developing Countries Case Study
Raye' Tabor November 15, 2017 Ethical Issues in Clinical Trials in Developing Countries Due to the lack of money but the high demand of need of
specific regimens in developing countries, researchers from developed countries are allowed to conduct trials on those citizens. In this article, Baruch
Brody argues against moral criticisms given towards clinical trials in developing countries. His three arguments are the subjects weren't treated unjustly
(following an appropriate standard of justice), the subjects weren't coerced (in terms of any plausible interpretation of the word), and the subjects
weren't being exploited (if they themselves gain access to the treatment after the study). While conducting the study, there are two groups:... Show more
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Lastly, Brody uses (for lack of a better term) a "legal loophole" to justify how those involved were not exploited. Critics believe since the treatments in
the studies being conducted are not going to be available to those in the developing countries they are being tested in, the country is being exploited. To
Brody, though, the issue does not lie in exploiting the country as a whole, but in exploiting those directly involved in the study. For him, this issue can
be resolved by simply ensuring their future treatment. Of Brody's three arguments presented, the correction to exploitation is easily criticized. If we
were to agree that the country as a whole cannot be considered when deciding whether or not exploitation is evident, and only focus on the participants,
another issue arises. One can then say that those in the control group are being exploited, due to the lack of knowledge that they are not receiving the
treatment being tested. Because the subjects agreed to participate on the basis that they would receive treatment, not giving them the treatment is the
exact meaning of exploitation. Also, by being placed in the treatment group, they have not benefited from the study at all, making the treatment group
the only subjects to not have been exploited. In response to this criticism, Brody explains that under the local standard of care, participants in these
trials would not
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Process Of A Clinical Trial
Working Title: TBD
Authors: Aron Shapiro
A search on clinicaltrials.gov for the term "retina" yields well over 800 on–going studies of alternative systems of drug delivery, gene therapy, stem cell
treatments, imaging systems, and much more. While most retinal specialists are fully prepared to implement new techniques in the setting of a clinical
trial, these new, sometimes invasive, protocols can seem daunting and scary to patients. To recruit subjects who will commit to a long–term study, it's
vital to take the time to discuss the details of the trial in order to appropriately manage the patient's expectations.
Starting Off Right
Before the recruiting process begins, it's important for the investigator to "buy in" to the clinical rationale and approach: he or she must feel confident
that the proposed intervention has meaningful potential in the treatment of the target disease. This belief can be based on preliminary studies,
biological plausibility, and presence of a true unmet need. Without the investigator's commitment in the intervention at hand, it will be virtually
impossible to recruit potential patients and come to an agreement with the patient that enrolling in a study is the most appropriate plan–of–action. If the
investigator is enthusiastic about the potential of the therapy, the next step is deciding which patients are the most suitable candidates.
The identification of ideal patients starts by matching candidates with the particular diagnosis and then
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Covance Leeds Clinical Trials For 25 Years
Covance Leeds Clinical Trials
The Covance UK Leeds Clinic has been conducting clinical trials for 25 years and has made quite the name for themselves with the world's leading
medicinal companies. Because Covance Leeds does both Phase I and Phase II clinical trials, paid volunteers are accepted per clinical trial basis
regardless of health. So healthy or patient, you can be paid to take part in their clinical trials.
Getting to Know the Covance UK Leeds Clinic
Established in 1986, Covance Clinical Research Unit at Leeds carries out Covance clinical trials for some of today's leading pharmaceutical and
biotechnological companies. Covance Leeds Clinic works with these companies in Phase I and II testing such as drug absorption, reaction, ... Show
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Although Covance clinical trials can carry some risk, you can trust the 25 years of experience that Covance UK has earned in safely conducting
clinical trials. As well as having a team of medical experts to keep you healthy and safe, Covance UK also has the Research Ethics Committee and
the UK Medicines and Healthcare products Regulatory Agency (MHRA) approve each Covance Leeds clinical trial before it starts to set up
appropriate safeguards for all of their healthy and patient volunteers. Qualified doctors and nurses are on hand to monitor your safety at all times.
The Covance UK Leeds Clinic Staying onsite for the duration of your Covance medical trial is mostly dependent upon the Covance clinical trial
that you take a part in. Since a clinical trial can last from two nights to a month, the Leeds Clinic provides wonderful accommodations to all of their
healthy and patient volunteers. These offers include satellite television, internet and wifi, a pool table, free arcade games, XBox 360 & PS3, board
games, DVDs, a book library, daily newspapers, organized events (quizzes & bingo), quiet rooms, modern showers, 3 catered meals a day, and a
smoking room (if allowed on your study).
There are a few things you as a volunteer will have to bring in order to make your stay more comfortable. You should of course bring your own clothes
and toiletries as well as
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Organizing A Global Clinical Trial Involving A New Serum...
The topic of "organising a global clinical trial involving a new serum marker to detect the early onset of lung cancer" has numerous potential discussion
points. Firstly, it is necessary to understand what is meant by "clinical trial". A clinical trial is any research or study which assigns human participants
to one or more health related intervention3. These interventions are then evaluated to determine the effects on health outcomes, such as disease3. Since
clinical trials are centred around human participants, human ethics underpin every aspect of the clinical trial. The aim of a clinical trial is to develop
safe medical treatments and vaccines1, so human participation is essential to ensuring these drugs are safe and effective. In the ... Show more content on
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Global clinical trials are also necessary for rare diseases. This is because cases may be scattered across the globe, and to ensure enough participants
are recruited to gain scientifically useful data, researchers are forced to look globally1. As such, increasing the number of global clinical trials has
clear benefits to researchers and society.
In addition to the advantages of ensuring a drug is safe in various populations, globalisation has wide reaching benefits. The greatest benefit to scientists
and pharmaceutical companies is the reduced cost of conducting clinical trials in lower–income countries1. Clinical trials are driven primarily by the
work of physicians, nurses and trial coordinators1, and in lower–income countries the salaries of these workers are far less than in high–income
countries. The estimated cost of outsourcing clinical trials to clinics in these lower–income countries is between $1500USD and $2000USD2. This is
substantially lower than in high–income countries. The added benefit to consumers of reduced clinical trial costs is the reduction in price of the trial
drug. Globalisation of clinical trials shortens the period of time required to conduct clinical testing, which further reduces the costs of drugs2. This
results from the increased
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Clinical Trials And Its Effects On The Public Health Care...
Introduction
Pharmacovigilance is "the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other
medicine related problem." Regulated in the US by the Food and Drug Administration (FDA) with the expectation of volunteer reporting by health care
professionals (HCP) and mandatory reporting by drug developers/manufacturers, this field of study is essential in the improvement of patient outcomes
and safety. Its peripheral importance lies in contributions to cost effectiveness and risk management in the public health care arena. Responsible and
aggressive implementation of adverse event reporting procedures promote awareness and value to the importance of the identification of harmful effects
of medication use.
The stages of pharmacovigilance coincide with the stages of clinical trials. Each stage of a clinical trial has a pharmacovigilant component. The
preclinical phase which is restricted to animal testing is the first stage of research and development that determines safety. Once a compound is
determined to be safe in laboratory animals and has potential to be therapeutic in humans, it can be considered for Clinical Trials. Phase 1 of a
clinical trial is primarily to evaluate a new compound's safety in general and therefore is conducted with less than 100 participants which are
expected to be healthy. If the Phase 1 safety profile suggests a low risk factor for a drug, Phase 2 and 3 studies continue with the
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Grey's Anatomy Clinical Trial Participation
Clinical Trial Participation In the popular television drama, Grey's Anatomy, the main stars conducted a series of clinical trials that introduced
Seattle into a new form of research. After their trial called the "Shepard Method" grew into a success, the program's audience became aware of
clinical trials in reality. In the previous years, clinical trials have evolved and made a big impact on society. However, there is controversy about
whether or not one should take part in clinical trials. People should participate in clinical trials because they are safe, a way to earn money, a positive
impact on the medical field, easy to perform in, and highly successful.
A clinical trial is similar to a research study that is conducted for many reasons. ... Show more content on Helpwriting.net ...
But, this is proven wrong because many studies do not consist of any long or hard tasks. According to the National Library of Medicine, a majority of
trials require "minimal amounts of time and effort" ("Clinical Research"). One example of a research procedure is shown by Bridge, "right handed
males aged 18 to 40 take part in a trial on the pain killing effects of Botox, which involves two outpatient visits." This case presents the low
complexity of a trial; in this circumstance only two visits are needed. Also, the only qualifications needed to participate in this case include: being a
middle–aged, right–handed male. A survey shows that studies are simple to take part in because the "most common discomfort is a headache from
caffeine withdrawal" (Bridge). Bridge clarifies that studies do not involve many extreme responsibilities to be performed from the participant because
the hardest task is to avoid drinking caffeine. A main reason for a trial to run smoothly and efficiently, without causing the patient to complete tough
labor is due to the health professionals. The article titled Putting Yourself On Trial justifies, "hard work is carried out by our professional medical
team, which leaves you free to relax and enjoy the facilities" (Bridge). Completing simple tasks is the key to participating in an easy clinical
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Clinical Trial and Joint Venture
GENZYME/GELTEX PHARMACEUTICALS JOINT VENTURE In early 1997, Greg Phelps, EVP of Genzyme Corporation, met with members of a
joint– venture negotiating team to develop proposed terms of a joint–venture agreement. The venture would combine capabilities of Genzyme and
GelTex Pharmaceuticals to market GelTex's first product, RenaGel. GelTex was an early–stage biotech research company with two products in its
pipeline. GelTex had neither the capital nor the marketing organization to launch RenaGel. Therefore, the company had been looking for a partner that
would contribute cash and marketing expertise in exchange for a share of profits in a joint venture. Genzyme had revenues of $518 million in 1996,
and had grown rapidly... Show more content on Helpwriting.net ...
The drug was approved for sale in the United States in March 1991 to treat patients suffering moderate to severe symptoms of Gaucher's disease, a
market of some 3,000 people. Two years later, the company launched a recombinant form of Ceredase and started to enter new markets–surgical,
pharmaceutical, diagnostic, and genomic products–through strategic alliances, joint ventures, and acquisitions. Such diversity allowed Genzyme to play
a leadership role in a broad range of cutting–edge technologies and therapies, according to Genzyme's chair, president, and CEO, Henri A. Termeer.2
The company's diversity came from its threea divisions–Genzyme General; Genzyme Tissue Repair; and a subsidiary, Genzyme Transgenics
–each with
its own common stock traded on the NASDAQ (Exhibit 1). The wide array of technologies provided Genzyme with an excellent platform for achieving
breakthroughs in major unmet medical needs. Rather than concentrate efforts on the next big hit, however, the company had decided to manage its
R&D like a portfolio by outsourcing innovations through partnerships. Genzyme's strategy was to supplement its internal R&D with strategic alliances
with external
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Clinical Trials Are Medically Based Experiments
8CLINICAL TRIALS 8.1INTRODUCTION Clinical trials are medically based experiments undertaken on human subjects to systematically determine
the effectiveness and/or safety of therapeutic interventions. Formal definitions of clinical trials are numerous, but they capture the concept of an
organized, systematic study of human subjects in a treatment environment that is consistent.245 Studies are created to measure different things, such
as determining whether a treatment is effective compared to a placebo or determining whether one treatment is more effective than another.
Increasingly, the cost of therapy is also being added into the studies to create what are called cost effectiveness analyses, in which the effectiveness of
various... Show more content on Helpwriting.net ...
The Helsinki Declaration of 1964. The 1971 Guidelines by the US Department of Health Education and Welfare, codified into formal Federal
regulations in 1974. The Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and
Behavioral Research is required reading for all researchers. This document provides the ethical underpinnings of most of the U.S. Federal regulations
governing human research. The document sets out the difference between the practice of medicine and research, ethical principles including the
principles of respect for individuals, beneficence and justice, and more specific the application of these principles to actual research. For example, the
document discusses informed consent, the assessment of risks and benefits and the design of research, and the selection of subjects. The International
Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use guidance documents. Referred to
usually as the International Conference on Harmonization, or ICH, this group developed international standards in the early 1990s that were adopted in
large measure by the United States and once followed, permit the exportation of research results across international borders without the need for
repetition or
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A Multistep Recruitment Strategy to a...
Available online at www.sciencedirect.com Applied Nursing Research 23 (2010) 227– 232 www.elsevier.com/locate/apnr A multistep recruitment
strategy to a participant–intensive clinical trial Kim Dupree Jones, PhD, RNCa,вЃЋ, Ann C. Reiner, RN, MN, OCNВ®b a Oregon Health & Science
University, Schools of Nursing and Medicine, Portland, OR 97239–2941, USA b Oregon Health & Science University, School of Nursing, Portland,
OR, USA Received 25 June 2008; revised 28 August 2008; accepted 2 September 2008 Abstract Adequate access to well
–informed study participants is
key to rapid recruitment and retention to randomized controlled clinical trials (RCTs). We describe a novel seven–step recruitment process for enrolling
participants in... Show more content on Helpwriting.net ...
Jones, A.C. Reiner / Applied Nursing Research 23 (2010) 227–232 employing traditional ways of recruiting. In FM RCTs, the most common way to
recruit participants is through invitation letters mailed to potential participants who are patients in a rheumatology practice. Recruiting through this
method, however, does not protect a study from high attrition; in one aerobic exercise study in patients with FM, attrition rates were as high as 67%
(NГёrregaard, Lykkegaard, Mehlsen, & Danneskiod–SamsГёe, 1997). Another standard recruitment strategy is to employ a research assistant on site
to wait for referrals from the FM provider. Appealing to referring clinicians to recommend patients to consider a study is also a commonly used
strategy (Reisine, Fifield, & Winkelman, 2000; Veenhof, Dekker, Bijlsma, & van den Ende, 2005) but in our experience is less successful without
immediate patient follow–up. There are several disadvantages, however, to all of these clinic–based recruiting approaches. One is that participants may
believe that the research study is in the best interest of their clinical care. Another is that patients in a clinical setting may not have adequate time and
energy to fully understand the study participant responsibilities or give informed consent due to the increasing length and complexity of consent forms.
Consequently, participants may drop out when the study does not meet their expectations (e.g., they are randomized to the placebo group or they
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Registration Of Clinical Trial : Advantages,...
Registration of Clinical Trial: Advantages, Disadvantages Industrial, and Consumer Perspective Introduction Registration of clinical trials has been a
controversial issue for years. According to ICMJE, a clinical trial is any research project that prospectively allocates people or a group of individuals to
intervention, with or without concurrent comparison or control groups, to study the cause and effect relationship between a health related, intervention
and a health outcome. Health–related interventions are those used in the modification of biomedical or health–related outcomes such as drugs, surgical
procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and the... Show more
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The project intends to take the lead in setting international norms and standards for trial registration and reporting (World Health Organization).
Additional the International Committee of Medical Journal Editors (ICMJE) made an announcement of a tough stance on trial registration. One
regulation being that after 1 July 2005 trials that begin enrollment of patients must register in a public trials registry at or before the onset of
enrollment to be considered for publication in those journals. Trials that began patient enrollment on or before 1 July 2005 must register before 13
September 2005 to be considered for publication Importance The need for trial registration received a lot of acknowledgment for years. However, it
was not until in 2004 when the revelation that trial data on the harms of specific serotonin reuptake inhibitors in children went undisclosed that its
urgency became especially evident. Legal action by the Attorney General of New York 's upon GlaxoSmithKline and the decision of medical journal
editors not to publish any trial unless it is has been registered put emphasis on the importance of registering trials (Dyer). Considering that
transparency in research and knowledge, sharing is now widely seen as a precondition for the success of the health research enterprise makes trial
registries a valuable tool to help achieve this transparency. In the same way, advances in technology made research methodology evolve so are the
Internet in making
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Clinical Trial Endpoints Case
Topic: You are designing a clinical trial for a drug company. How would you identify study endpoints that are meaningful to patients?
Statement of Problem:
Treatment effectiveness has been defined as a clinically significant benefit to the patient, with the objective of the patient living for longer or better, or
both, than if they did not receive the treatment (Wilson et.al., 2015). This measure of efficacy might be shown by symptomatic improvement, or
improvement in established disease progression endpoints (Wilson et.al., 2015). Since clinical trial endpoints have profound effects on late phase
clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics, the characteristics of the disease and ... Show more
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Finally, clinical trial endpoints and the standards to which they are held significantly impact the regulatory and approval process for new drug
applications.
References:
1. Casarett, D., Karlawish, J., Sankar, P., Hirschman, K., & Asch, D. A. (2001). Designing Pain Research from the Patient's Perspective: What Trial End
Points Are Important to Patients with Chronic Pain? Pain Medicine,2(4), 309–316. doi:10.1046/j.1526–4637.2001.01041.x
2. Herzog, T. J., Armstrong, D. K., Brady, M. F., Coleman, R. L., Einstein, M. H., Monk, B. J., . . . Alvarez, R. D. (2014). Ovarian cancer clinical trial
endpoints: Society of Gynecologic Oncology white paper. Gynecologic Oncology,132(1), 8–17. doi: 10.1016/j.ygyno.2013.11.008
3. Minion, L. E., Coleman, R. L., Alvarez, R. D., & Herzog, T. J. (2016). Endpoints in clinical trials: What do patients consider important? A survey of
the Ovarian Cancer National Alliance. Gynecologic Oncology,140(2), 193–198. doi: 10.1016/j.ygyno.2015.11.030
4. Wilson, M. K., Karakasis, K., & Oza, A. M. (2015). Outcomes and endpoints in trials of cancer treatment: the past, present, and future. The Lancet
Oncology,16(1).
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Ethical Dilemma On Randomized Clinical Trials
Ethical Dilemma on Randomized Clinical Trial Randomized clinical trial (RCT) is the most effective way of conducting research on the efficacy and
safety of newly developed drugs and medical treatment for public consumption. Like most experiments, there are usually two groups in conducting an
RCT: the placebo group and experimental group. In the placebo group, the subjects receive a placebo drug or a drug that is already available and is
used to treat a particular disease and in the treatment group, the subject receives the newly developed drug or treatment. However, in the RCT, the
subjects that agreed to participate in the clinical trial are randomly assigned in either placebo or experimental group in order to eliminate observer bias
and distribute the subjects' variables evenly on all groups. Furthermore, RCT is either single–blinded or double–blinded. In single blinded RCT, the
subjects cannot know if they are placed on placebo or experiment group. Moreover, the subject cannot know anything about the progress of the trial. As
for the double–blinded RCT, both the subject and the physician–scientists who are conducting the trial do not know which subject are in which group
and whether a particular treatment's progress.
According to the Hellmans, because of the nature of RCT, physician–scientists are placed in a serious ethical bind that it poses to physician–scientists,
therefore, we should abandon this practice altogether. In order to explain how this ethical dilemma
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Risks Associated With A Clinical Trial
How a subject perceives the risks associated with a clinical trial is a critical piece of informed consent and has been shown to impact patients'
willingness to participate in clinical research (Kim, Tanner, Friedman, Foster, & Bergeron, 2015; Monson, Parlour, Simcock, Fallowfield, & Jenkins,
2011). There are multiple items which can impact a patient's perception of risk including disease state, gender, ethnicity, age, and factual and
subjective knowledge of clinical research. The impact disease state has on a patient's perception of risk varies with the type and severity of disease as
well as the availability of alternate treatment. For example, patients view the discovery and development of new treatments for severe conditions as
more important than the discovery and development of new treatments for mild or moderate conditions (Center for Information in Study on Clinical
Research Participation (CISRP), 2015). This factor especially impactful in the research of oncology drugs where patients (often with severe conditions)
are more inclined to participate the research of new treatments (Walsh & Sheridan, 2016). Because Prader–Willi syndrome is a currently incurable
genetic disease with few treatments, this item is important for this study. The gender/sex of the patient may also impact his or her willingness to
participate in a study. In cardiovascular prevention trials, "women perceived greater risk of harm and myocardial infarction" than men which resulted in
women
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The Importance Of Post Clinical Trial Results In The...
Background Information
From 21 July 2014 it became compulsory to post clinical trial results in the European Clinical Trials Database (EudraCT) which is managed by the
European Medicines Agency (EMA) and it is essential for clinical study information to be made more reachable and accessible. By saying 'Clinical Trial
' the agencies are referring to any trials on new drugs that are in preparation for a regulatory submission, drugs, devices or procedures on any medical
interventions and any other investigations that involves of participants for research purposes, for example psychology studies. All of these clinical
trials may generate numerous amounts of result or data. Traditionally only a few results were published in journals and they ... Show more content on
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This also avoids excessive research and expands the accessible evidence on an intervention.
Four sets of information are needed:
–Whether the trial has actually happened, which means it is necessary for the trial to be registered. Information such as the study protocol, analysis
plan and possible completion date of the trial could be registered before the trial starts. This means the final result could be checked against the
protocol and would be easier to find out about any 'non–published' trials.
–Summary of the method and results – brief summary and result for every trial that was conducted.
–Clinical Study Reports (CSR) – to see whether there were any amendments to the protocol during the course of the trial, which could mean that
somebody has noticed something in the result and they want to change the analysis in a way that is more flattering. Often information on adverse
events is very incompletely reported in journal articles but much more completed in CSR.
Clinical Study Report (CSR) is a lengthy and comprehensive document that gives information in regards with the methods and results of a clinical
trial. This document is submitted to regulatory by a company who is looking for approval to market a 'novel drug'. It is a source that addresses
efficacy and safety.
–Individual Patient Data (IPD) – this can be defined as the raw data from a clinical trial that has been treated to
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Issues of Clinical Trials in India by Vallinadh Karamcheti
Clinical trials in INDIA– Legal issues By: Vallinadh Karamcheti Abstract: Clinical trials are conducted to ensure the safety and efficacy of the drug.
They are conducted on the human subjects. Hence the clinical trials are liable to many legal aspects. Clinical trials are conducted in four phases.
(Phase I, Phase II, Phase III, & Phase IV). All the phases of the clinical trials should comply with several legal aspects, as life of a person may be at
risk if anything goes wrong with the clinical trials. They should comply with the Schedule Y of Drugs and Cosmetics Act, 1940, Drugs and Cosmetics
(II Amendment Rules) Rules 2005, Good Clinical Practices guidelines, 2001 etc. What are clinical trials? Clinical trials are the tests conducted... Show
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Pre–clinical trials includes Pharmacological testing to check that the drug do not produce any hazardous effects such as cardiac arrest, cardiac
dysrhythmias, acute bronchoconstriction etc. Preliminary toxicological testing to eliminate genotoxicity and to determine the maximum non–toxic
dose of the drug. As well as being checked regularly for weight loss and other gross changes, the animals so treated are at the end of the experiment to
look for histological and biochemical evidence of tissue damage. Pharmacokinetic testing, including studies on the absorption, metabolism, distribution
and elimination (ADME studies) in laboratory animals. Chemical and pharmaceutical development to assess the feasibility of large–scale synthesis and
purification, to assess the stability of the compound under various conditions, and to develop a formulation suitable for clinical studies. Much of the
work of preclinical development, especially that relating to safety issues, is done under a formal operating code, known as Good Laboratory Practice
(GLP). The aim of GLP is to eliminate human error as far as possible, and to ensure the reliability of the data submitted to the regulatory authority, and
laboratories are regularly monitored for compliance to GLP
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The Global Clinical Trial Is A Very Challenging Job
The global clinical trial is a very challenging job; it involves strategic decision making which can affect drug development and approval process. Many
factors should be considered in selecting countries, most common in feasibility studies include: the prevalence of the disease, regulatory requirement,
patients' recruitment, experience clinical trial specialist availability, ethical issues, language barrier, and marketing strategy. In this report, we perform a
thorough assessment of conducting clinical trials in countries such as Canada, Germany, Spain, Japan and the US. The criteria chosen for this
assessment include disease prevalence, insurance coverage, patient enrollment rates, regulatory environment and finally costs associated with ... Show
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Additionally, the rates of heart attack are 1.8 times higher among adults diagnosed with diabetes than those without a diagnosis. When compared with
men, women of all ages diagnosed with T2DM have even a higher risk of heart disease (NIDKK, 2016).
Why selection of Germany? According to traveler's digest, Germany's size is comparatively small to the state of California (2014). Despite its small
size, Germany ranks amongst the worst for all things diabetes. As of 2008, 7.4 million (12% of the total population) adult citizens are plagued with
diabetes in Germany with an additional 4.1 million citizens on the brink of having the condition with prediabetes. Type II diabetes accounts for about
80–90% of all diabetic cases in Germany. It 's also significant to note that 1/10 diabetes sufferers in Germany also have coronary heart disease (Novo
Nordisk, 2008). Additionally, there have been a predicted 3 million undiagnosed cases of diabetes waiting to add to more startling statistics (Tenderich,
2011).
When it comes to clinical research, it appears Germany has a legitimate presence and good rapport with industries that cater to healthcare. Germany's
involvement in clinical studies far exceeds its demographics with a strong medical tradition as well as a
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Ethics of Offshoring: Novo Nordisk and Clinical Trials in...
Ethics of Offshoring: Novo Nordisk and Clinical Trials In Emerging Economies
Offshoring is a highly debatable topic throughout the country and the world. Many people base their opinions on different aspects of offshoring.
Some people are against offshoring because they feel as if the working conditions in other countries aren't up to par and are unethical. Some people
are against offshoring because they feel it is taking jobs away from people within their own country. Some people are for offshoring because they feel
there is greater profit involved or that they can get harder workers in other countries. No matter what side of the debate, everyone can agree on a few
things like there needs to be better standards for working conditions, ... Show more content on Helpwriting.net ...
Another question that needs to be addressed is if trials are conducted in an emerging economy, how should they be managed and which standards
should apply? I think medical ethics is a big issue when it comes to trials being conducted in an emerging economy. One famous incident of this was
the Tuskegee syphilis study. This study left 400 African Americans untreated in order to research how they obtained the disease. The cure for
syphilis, penicillin, had already been found in the 1940s. To prevent this from happening again, professional medical organizations developed
guidelines and principles of ethics to guide their research, notably the Helsinki Declaration. I believe Novo Nordisk does a great job of adhering to
these guidelines by putting safety measures in place. Emerging economies like India and China are attractive places to have clinical trials because of
how much cheaper it is, the willingness to try new things as an emerging economy, and because a possible lack of standards. Novo Nordisk only
conduct trials in countries where they have affiliates with necessary competence to arrange and monitor the trials. Also, they conduct clinical trials
globally to test the safety and efficacy of new drug candidates in order to obtain global marketing authorization. These trials always have the same
standards at all trial sites. The standards in
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Animal Models And Clinical Trials
(WY Mak et. Al, 2014) discusses the concerns of the fact that many drugs that are successful in animal trials are not successful in clinical trials, most
specifically, drugs used in cancer treatments. Animal models have been an important factor in the testing of a new drug before it is used in clinical
trials, but many drugs that are approved in animal models are not successful in human models. It has been shown that 85% of early clinical trials for
novel drugs are not successful and from the remaining 15%, only half are approved for human use. The reason there is a difference in results
between animal models and clinical trials have to do with the inability of animals to identically mimic human body functions. An example of a trial
that had a difference in results is the TGN1412 trial. TGN1412 was a drug used to treat diseases such as MS, rheumatoid arthritis, and certain cancers.
Before used in clinical trials, this drug was first tested in mice. There were no complications shown in mice that would indicate complications in
humans. Humans in clinical trials were given a dose 500 times lower than the dose given to mice and it resulted in catastrophic organ failure. Another
study involving IPI–296 in patients with advanced chondrosarcoma was ended early due to the fact that it had no effect shown in clinical trials. When
IPI–296 was used on mice, they were shown to have an increase in survival rate. This showed that the effects of the drug on animal models was different
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Clinical Trials
These events are just a few examples of the ways that medical companies might take advantage of people in developing countries in order to further
their research more quickly and increase their profit. An ever increasing number of trials are being held overseas; in 2008, nearly 65 percent of trials
on products registered from within the United Sates were conducted in other countries. With this growth, the need to make sure that vulnerable
communities are not exploited also increases; while the FDA did inspect roughly two percent of domestic trials, the number of overseas trials which
were inspected was less than half that number. (Wechsler, 2011) These are worrisome examples and statistics which all need to be addressed as the
medical community... Show more content on Helpwriting.net ...
A group of researchers sought to get a closer look at how clinical trials were carried out by talking to nurses who were working with drug trials. While
participants in this study were all located in the United States, their experiences are pertinent when considering the ethical concerns involved in all
clinical trials. The nurses who participated voiced a variety of concerns while they were working with clinical trials. They reported that despite consent
being voluntary, and patients being told that they could discontinue a study at any time, there were some conflicts between this and the actual practice.
Nurses who lost subjects in the study were often penalized and reprimanded, seemingly encouraged to sacrifice the patient's rights and desires in order
to keep them in the trial. They also talked about how higher ups, who might be in charge of funding or the legalities, are often out of touch with what is
actually ideal in the practical sense, rather than the bottom line. One nurse gave the example of how legally, one official might want the consent form
to be three pages long, another might want it cut down considerably, and the nurse, who is actually performing the study, wants a consent form which
is both thorough as to protect the patient, but concise and clear enough to be easily understood by the patient. Furthermore, nurses might be asked
about their own opinions by their patients, which leaves them in a difficult situation where they could be using their authority to pressure someone into
a study. All of these are difficult things to balance, and very valid concerns brought forward by individals with hands on knowledge of these trials.
(DeBruin, Fisher & Liaschenko,
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The Total Number Of Clinical Trials
The total number of clinical trials in Portugal has recently experienced a reduction in a
12
13worrying trend revealing a significant loss of competitiveness in this field. Between 2006 and
142012 the number of trials decreased by 26%, i.e. from 160 to 118 studies. The trough in these
16numbers only arrived in 2011, when just 88 studies took place. This trend shall only either
17
18prevent or hinder the achievement of social and/or political benefits, such as the improvement
19
20of medical and supportive care, job creation, the organization of health facilities and early
21access to innovative medicines and research methodologies 1. The reasons for this decrease
22
23stem from numerous aspects, including the cost and difficulties of attracting volunteers to
24
25participate in such studies.
26
27
28The effectiveness of a clinical trial depends on the size of its sample, sample homogeneity,
29
30the similarity of the results and the differences among the mean values for each group. In this
31kind of study, it proves very difficult to achieve the minimum participant numbers required to
32
33obtain the ideal sample size. This situation occurs for various reasons including the study cost,
34
35the low frequency of certain diseases, uncertainty about the effects of treatment, and among
36others 2.
37
38
39
40Considering this framework, certain actions might be implemented in order to reverse this
41scenario. Some techniques and marketing strategies
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The Ethics Of The Clinical Trials
In recent years, the number of clinical trials increased significantly. With an increasing number of clinical trials, the ethical issues related to clinical
trials have also increased. Furthermore, the ethics of the clinical trials were violated on several occasions in last few decades. Nazi experiments with
World War II initiated the world leaders to implement a code of conduct that protects the autonomy of theclinical trial subjects. Therefore, the
Nuremberg Code was initiated in the year of 1949. However, this Code failed to protect the human subjects in clinical trials. Tuskegee syphilis trial
was one of the few incidents that were exposed in front of the entire country. The regulatory agencies and the government then realized that there
should be better regulations to protect the human subjects in the clinical trials. A series of codes and regulations were established to protect the
subjects in the clinical trial after the Tuskegee incident. The Belmont report (1979), International Conference on Harmonization guideline for Good
Clinical Practice (1996), the Declaration of Helsinki (2000), and CIOMS International Ethical Guidelines for Biomedical Research Involving Human
Subjects (2002) are the main guidelines in recent years. There are also federal regulations to protect human subjects in the clinical trials. They are
USCFR Title21 Part 50, 56 (Protection of Human Subjects and Institutional Review Boards, 1991), and USCFR Title 46 (The Common Rule, 1981).
These federal
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Taking a Look at Clinical Trials
Every medical innovation starts with an idea or vision, and goes through several developmental stages, namely, basic research, translational research
and clinical research before being able to market the treatment. (4) This treatment can be a drug, a medical device, a vaccine, a blood product or gene
therapy. (3) The basic research is done in a laboratory, where cell function is studied, and it is determined under what conditions the treatment could
cause cells to function more effectively. The treatment is then tested in animals to see the effect, and to test possible toxicity. Once the treatment has
been named safe for use in animals, it can then be tested in humans. (4) Clinical research, or clinical trials, involves the testing of the treatment in
human volunteers, working towards the approval of the treatment to be marketed. (3) The research that bridges the gap between studies done in the
laboratory and clinical trials is then known as translational research. (4)
The main purpose of a clinical trial is to determine if the treatment is safe and effective for human use, and is required by the Food and Drug
Administration (FDA) before a treatment can be approved. There are, however, other reasons these trials are performed. They can be used to compare
the new treatment to an already existing one to determine which is more effective, and to determine different ways in which to use current treatments
in order for them to be most effective, easiest to use and provide the
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Case Study Of The KIWI Clinical Trial
subjects 6–11 years old (ppFEV1=95.8% at baseline) and a more progressed disease state in the adult subjects (ppFEV1 = 64.5% at baseline).(36)
The KIWI clinical trial was a two–part, open–label, phase 3 study to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of
ivacaftor in CF patients between two and five years old with at least one CFTR gating mutation. Results from this study expanded the use of ivacaftor
to patients as young as two years old (Table 1).(15)
Despite in vitro results demonstrating an increased Isc in F508del–CFTR expressing FRT and HBE cells upon forskolin stimulation,(22) no therapeutic
benefit was observed in CF patients homozygous for F508del–CFTR. The DISCOVER trial was a phase 2 study to test ... Show more content on
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Part 2 assessed multiple ascending doses of D9–ivacaftor (75mg, 150mg, and 225mg), each administered daily after a high–fat meal for 7 days,
compared to placebo.(68) Results presented during the 39th European Cystic Fibrosis Conference demonstrated improved PK of D9–ivacaftor
compared to KalydecoВ®, including a 40% increase in half–life (D9–ivacaftor t1/2 of ~15hrs; KalydecoВ® t1/2 of ~11hrs), reduced clearance rate
(D9–ivacaftor CL/F of 3.8L/hr vs. KalydecoВ® CL/F of 13.3L/hr), approximately 3–fold increase in exposure (D9–ivacaftor AUC0–inf of 44,916ng*hr
/mL vs. KalydecoВ® AUC0–inf of 12,925ng*hr/mL), and approximately 3–fold increase in plasma concentrations at 24–hours (D9–ivacaftor C24hrs
of 712ng/mL vs. KalydecoВ® C24hrs of 169ng/mL). Data shown here are for 150mg doses of both D9–ivacaftor and KalydecoВ®.(14, 26, 77) The
improved PK profile of D9–ivacaftor along with a safety profile comparable to that of KalydecoВ® has allowed progression of D9–ivacaftor into a
phase 2 clinical trial to evaluate its safety and efficacy in CF patients with CFTR gating mutations.(69)
QBW–251
QBW–251 is a CFTR potentiator developed by Novartis Pharmaceuticals Inc. In vitro results showed QBW–251 to be an effective potentiator for
CFTR gating mutations, including F508del–CFTR. Promising in vitro results led to the initiation of a
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The New Eu Regulation For Clinical Trials
The new EU Regulation for clinical trials (EU Regulation 536/2014) is expected to be implemented in May 2016. This governs research on
'investigational medicinal products' –which could be new medicines or off license use of an authorised product.
Whilst it is widely recognised that clinical trials are needed to develop new medicines, they also lead to an improvement in medical care more
generally. The new regulation aims to remove the barriers to clinical research across Europe by–
1. Speeding up of the process for authorising new clinical trials and reducing the administrative burden associated with the conduct of these studies.
2. Developing a single EU portal for applications, allowing all member states to participate, which should allow tightly defined subgroups (i.e based on
genomics) to be recruited in adequate numbers. There will also be an EU database for safety reporting, preventing researchers from having to submit
largely identical information on the conduct of the study separately to various national bodies.
3. Increasing the number of applications to carry out clinical trials
4. Reducing costs and delays associated with launching a clinical trial
5. Reducing the amount of regulation for trials of medicines which are already authorised and which pose only minimal risk compared to normal
clinical practice
6. Formally recognising co–sponsorship, facilitating NHS/University cooperation.
7. Encouraging greater transparency in trial milestones and in the
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Clinical Trials Regulations
Clinical trials regulations aim to create an environment that is favorable for conducting clinical trials, with the highest standards of patient safety.
Guidance documents have been issued by the regulatory departments to assist in the interpretation of policies and regulations and to ensure a uniform
application of the legislations on clinical trials. Although regulatory departments in Canada, U.S., and Europe, follow the same principles to ensure the
safety and wellbeing of the research participants and the integrity of the clinical research, their regulations for conducting clinical trials may have
differences that need to be considered when sponsors are conducting multisite international trials. The variations in the regulatory requirements
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Globalization Of Clinical Trials And The Pharmaceutical...
Name; Layth Al–Kinani, Globalization of clinical trials, Globalization has been adopted in many industries, in the pharmaceutical world, efforts
around globalizing clinical trials into emerging markets have increased significantly. Noticeably there is increase in numbers of trials in areas like
Asia Pacific, Central and eastern Europe, Latin America, and Middle East. Since 2002, 15% annual growth has been observed in the number of active
FDA– regulated investigators bases outside the United State, while the number of U.S. based investigators has decreased by 5.5%. One explanation
for this dramatic shift in the location of clinical trials is that, the pharmaceutical companies, realized the coast saving effect of conducting trials in
developing countries, as affected by the lower salaries of physicians, nurses, and study coordinators in developing countries; a reason for moving
phase 2 and 3 trials to places such as India and South America. Another important factor, is the large pool of potential research participants, provides
opportunities to accelerate recruitment. Furthermore, what also attract the pharmaceutical companies to conduct their trails in developing countries is
the less regulatory barriers for drug approval, in which the population size alone, offers the promise of expanding markets. Global trials are also
necessary to find patients for rare disease studies, and in response to the spread of Western diseases such as heart disease and cancer. Outsourcing of
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Clinical Trials And The Medical Field
Clinical trials are research processes that test the safety and effectiveness of various medical treatments using ethical means ("What are Clinical
Trials"). They are performed to discover new, effective, and practical cures for many conditions including cancers. Whenever a new possible drug or
potential cure is introduced into the medical field, it enters the clinical process in order to be analyzed and assessed for possible flaws and to maximize
effectiveness. Clinical trials are essential to development in medicine because of their capability to discover new and more efficient cures for serious
conditions and to improve on past solutions to make them easier and faster to perform. The impact of clinical trials in the medical field has ... Show
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There are many different forms of clinical trials, each designed for separate medical purposes. The most common form of a clinical trial is a treatment
trial, designed for cancer patients. This trial is designed to test the safety and effectiveness of new treatments ("Types and Phases of Clinical
Trials"). This type of research is very prevalent in medicine and is used often to discover new possible cures. Diagnostic trials analyze new
processes or technology that can aid in diagnosing forms of cancer with more ease and in a more accurate way. They help develop newer
technology which can allow cancers to be detected more efficiently. Similarly, there are also screening trials which examine new technology to
diagnose cancers earlier than previous methods. They are a form of diagnostic trials which can help spot cancers in earlier phases to prevent
metastasis and allowing for proper treatment to be administered as soon as possible. In addition, there are prevention trials which investigate new
processes to prevent cancers from originating in the first place. These trials try new methods and products to avert healthy citizens from developing
serious conditions. Various trials are used for different purposes so the proper cure or method of prevention can be developed for a target group or
sample.
A clinical trial is designed by scientists in order to test the impact of
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Clinical Trials : Pediatric Cancer
I)Introduction 1.Pediatric cancer 1)Approximately 70% of children diagnosed with cancer in the United States are cured, with a 5–year event–free
survival rate of 80%1 2)Pediatric cancer is relatively rare – around 12,000 new cases diagnosed each year in the United States1 3)Pediatric oncology
trials typically have high rates of accrual2 1.High accrual must be balanced with ethical treatment2 2.Overall goal is "optimal recruitment", which
focuses on allowing families to make informed decisions2 4)Drugs are typically tested and approved in the adult population before being introduced to
children3 1.Children are pharmacologically different than adults, thus a need exists for pediatric clinical trials – possibility of different adverse event
profile, etc.3 2.Challenges involving pediatric cancer trials 1)Ethics of phase I trials in children 1.Definition of phase I trial (i)Purpose is to determine
the safety (maximum tolerated dose), toxicity, and pharmacokinetics4 (ii)Phase I trials do not assess efficacy of the drug4 2.Safety of phase I trials
(i)Treatment–related mortality rate of 0.5%4 (ii)Overall well–tolerated – only 25% of patients typically experience a grade 3 or higher toxicity4
3.Understanding of risks and benefits of phase I trial (i)Phase I trials can involve toxicity and only provide a minimal chance of direct benefit to the
child – 6.8% for single novel agent and 20.1% for novel agent/known anti–cancer drug combination4 (ii)Potential benefits
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The Alliance For Clinical Trials
The Alliance for Clinical Trials in Oncology is a collaborative effort that is committed to developing and conducting clinical trials to reduce the
impact of cancer in patients from all over the world. In recent years this group was formed by three different cooperative groups creating a strategic
alliance by combining forces to provide the best services for customers. The customer base in this industry is patients diagnosed with cancer who are
seeking cutting edge and experimental treatment options. There are over 10,000 cancer specialists that collaborate in this mission to discover, validate
and disseminate effective strategies for the prevention and treatment of cancer. It is important to conduct these clinical trials to save the... Show more
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Another way that clinical trials are sponsored within the Alliance for Clinical Trials in Oncology is through pharmaceutical companies such as
Novartis, Celegene, Exelixis, etc. This creates an entirely different route for value analysis, although this is done on the pharmaceutical company side
as they are sponsoring the Alliance to conduct the trials. The pharmaceutical companies tend to ask for more in–depth cleaning of the data so priorities
can differ from that of the Alliance sponsored trials. I work on trials that are Alliance funded but I have spent most of my time within Mayo Clinic's
Cancer Center working on industry sponsored trials. I recently worked on a Novartis funded trial that developed a drug undergoing FDA approval to
treat patients diagnosed with Acute Myeloid Leukemia.
Supply Chain The first step in developing a clinical trial is the doctor's idea for a new treatment. Once it is determined to be scientifically viable and
after several committee meetings, a protocol is developed. A protocol is the official playbook or system of rules governing each step of treatment or
intervention from beginning to end. The protocol also explains the history of the disease and the treatment drug being used in the trial. Also discussed
are the primary endpoint and all endpoints thereafter and lays out the statistical considerations before the trial begins. This is a very intricate part of
creating clinical trials
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Outsourcing of Clinical Trials to Developing Countries
This paper explores outsourcing of clinical trials to developing countries focusing on current trend and providing brief overview of the clinical trials.
The paper covers major reasons for outsourcing of trials to developing countries especially focusing on India with ethical and scientific concerns raised
in conduct of clinical trials at foreign sites, throwing a light on growing career opportunities in developing countries and steps for ethical conduct.
Introduction:
Clinical Trial Outsourcing: Global Drug and Medical Device makers based in developed countries are now focusing on developing countries to carry
out their clinical trials. These players (pharmaceutical and device makers) have embraced outsourcing as a core ... Show more content on
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Clinical Trials are used to determine whether new drugs or treatments are both safe and effective. A clinical trial that is regulated by the U.S. Food
and Drug Administration (FDA) involves drug, biologic or medical device and fall into four phases each having different goals and designed to answer
specific questions.
The four different phases involved in clinical trials are:
Phase I: These studies are designed to test the safety of treatment. In detail, these studies are conducted to determine metabolic and pharmacologic
actions of interventions, the safety in human subjects and also to determine some evidence on efficacy. Phase I studies are conducted commonly in
healthy volunteers; however, there are some exceptions where studies are performed on actual patient population (e.g., cancer therapies). This phase
studies involve 20–100 subjects.
Phase II: These studies are conducted to test effectiveness of treatment and identify common side effects along with continuous assessment of safety.
These studies are conducted in patients who suffer from the condition which the drugs are intended to treat. This phase is involves several hundred
subjects.
Phase III: Phase III trials are designed to confirm whether the interventions are
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The Benefits Of Incentives For Clinical Trial Participation
In the Product factor, the "Relevance of the product" presents the highest mean (4.217) and
6the "Method of data collection" variable the lowest (3,646). The "Product" dimension spans
7
8innovation, relevance and the testing methodology; the mean for this factor (4.007) ranks it as
9of intermediate importance in comparison with other factors.
11
12
13In the Incentives factor, the aspect "To have access to free examinations" gains the highest
14mean value (4.239) with the "Payment/financial incentives" variable presenting the lowest
16(4.024). The factor "Incentives" derives its name from grouping variables such as the
17
18opportunity to receive free health care, financial incentives and other incentives (offers,
19
20samples, vouchers, etc.); its mean score (4.114) turns out one of the highest and thereby
21emphasising the influence of incentives to clinical trial participation.
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26Contact forms and communication tools
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30Questionnaire analysis allowed us to infer that higher education students prefer the
31Internet/Social Networks/Blogs (86%) as a means of contact for raising awareness and/or
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33participating in a clinical trial; however, that health professionals attain a considerable
34
35percentage (73%), as does email (68%), is also noteworthy. When asked about the
36media/tools that might increase their interest and/or participation in clinical trials or
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Clinical Trial Essay

  • 1. Clinical Trial Essay Clinical trials are often designed to test new biomedical or behavioral interventions such as new treatments/drugs, prevention strategies, screening programs, diagnostic tests, and educational models. The rapid increase in the costs of conducting clinical trials has made the efficient design of clinical trials more important in recent years. For example, a new report published by Tufts Center for the Study of Drug Development (CSDD) expresses that the costs of new drug development which is one of the wide applications of clinical trials have been pegged at $2.558 billion, with a 145% increase over an estimate made in 2003 [9]. 2.Clinical trial classification Clinical trials are divided into two main classes based on how participants are allocated to different interventions: randomized and non–randomized controlled trials [21]. Non–randomized trials (also called quasi–experiment) assign participants to the treatments, procedures, or interventions by methods that are not random. These trials are used when randomization is impractical and/or unethical. They are typically easier to set up than randomized trials which need random assignment of subjects. Lack of random assignment in ... Show more content on Helpwriting.net ... In the simplest case, a 2x2 factorial trial design generates four sets of data to analyze based on whether subjects receive interventions A only, B only, both A and B, or neither A or B. Thus, the factorial designs can evaluate not only the effects of each intervention but also the interaction that may exist between two interventions (or treatments). For this reason, this trial design can be viewed as an efficient way to conduct two trials in one. However, it is not recommended when comparing the two interventions to each other is considered as a primary purpose ... Get more on HelpWriting.net ...
  • 2. Symptoms And Treatment Of Clinical Trials Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. (NIH.gov, 2016). There are different types of clinical trials. –Natural history studies provide valuable information about how disease and health progress. –Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Better approaches may... Show more content on Helpwriting.net ... Phase II trials: The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety. Phase III trials: The experimental drug or treatment is administered to large groups of people (1000–3000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely. Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment's risk, benefits, and optimal use (NIH.gov, 2016). Migraine is a common episodic headache disorder often associated with an impaired quality of life. Preventive, prophylactic treatment of migraine should be considered for patients who are significantly disabled by attacks and unresponsive to acute rescue treatment, and for those who respond to acute treatment but experience frequent attacks, as there is an increased likelihood of drug induced (rebound) headache in this population. An example of a prevention trial is treating a group of patients with migraines with 100mg/day topiramate in double–blind, placebo–controlled trials (Silberstein, 2004). Response rates were high, and onset of action usually occurred within the first month of treatment. Evidence from large, well–conducted, ... Get more on HelpWriting.net ...
  • 3. The Impact Of Hiring A Crc On Patients, Physicians,... A Clinical Research Coordinator (CRC) is a research professional working under the immediate direction of a clinical Principal Investigator (PI). While the PI is primarily responsible for the overall design, execution, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical activities and plays a crucial role in the conduct of a clinical study. This business case will highlight the role of Clinical Research Coordinators and the impact hiring a CRC will have on the success of a clinical trial. Results will be used to determine the viability and financial feasibility for hiring a clinical research coordinator. The scope of this business case will highlight the impact of hiring a CRC on patients, physicians, provider sites, and clinical trials. Decision makers will understand the costs and benefits of CRC staffing and will use this guide in their hiring process. 2.2Opportunity The current market for clinical research trials is evolving towards increasing productivity in clinical trials. There is a demand for cost–effective, faster, and more efficient clinical trial processes. Clinician and regulatory agencies are requiring more data from clinical trials, increasing the complexity of clinical trials. Trends towards complex clinical trials have created a demand for increasing clinical trial staffing. In addition, companies aiming for more successful clinical trials have had an impact on staffing. Since 2008, ... Get more on HelpWriting.net ...
  • 4. Clinical Trials Evaluation And Treatment Of Her2... Tanzir Mortuza PHAR 7100 Project 2 Clinical Trial Evaluation Primary Article: Vogel, Charles L., et al. "Efficacy and safety of trastuzumab as a single agent in first–line treatment of HER2–overexpressing metastatic breast cancer." Journal of Clinical Oncology 20.3 (2002): 719–726. 1.0 Introduction: Breast cancer is the most diagnosed cancer in the US for women (http://www.breastcancer.org/symptoms/understand_bc/statistics). Even though the diagnosis and treatment of this condition has improved dynamically over the past few decades, it is still one of the leading causes of mortality among the women in USA and all over the world. There are usually four stages of breast cancer (http://www.breastcancer.org/symptoms/understand_bc /statistics). ... Show more content on Helpwriting.net ... Around 25–30% of the total breast cancer patients are diagnosed with HER2 gene amplification (Vogel, Charles L., et al, 2002). Patients with HER2 gene overexpression also produces a higher level of protein therefore, the patients with this condition are susceptible to decreased disease free and shorter overall survival rate(Vogel, Charles L., et al, 2002). The non–targeted cytotoxic chemotherapy has been used as a standard treatment of this condition. However, there are several side effects for these non–targeted therapies; such as vomiting, nausea, headache, fatigue, diarrhea, dizziness, anemia, thrombocytopenia, leukemia, anxiety, depression, anorexia and so on(O 'Shaughnessy, Joyce, et al, 2011). Therefore, a lot of patients are unable to use cytotoxic chemotherapy as a standard treatment. It is necessary to have a safe treatment that can serve the unmet purpose of these patients. Trastuzumab is a monoclonal antibody that recognizes the p185 site of HER2 (Vogel, Charles L., et al, 2002). As this is a humanized antibody, it reduces the chances of immunological response in the human body that may occur if a murine antibody was used. At the same time, this humanized monoclonal antibody initiates the maximum recruitment of patients' endogenous immune system to attack and destroy the overexpressed cells (Vogel, Charles L., et al, 2002). The efficacy of this therapeutic has been already evaluated with presence of chemotherapy in several clinical ... Get more on HelpWriting.net ...
  • 5. Evaluation Of A Clinical Trial Essay 1.3Clinical Trials A clinical trial is a prospective study comparing the effect and value of an intervention(s) against a control in human beings (Friedman & De Mets, 2010). It is an assured way of determining whether an intervention has the hypothesized effect since researchers have control of most of the cofounders involved in the studies. Each of the participants is followed onward in time from a defined point in time, which is the baseline for the study. Participants are randomly assigned to the various intervention options to create comparable intervention groups. A protocol is one of the requirements of a properly designed trial. A protocol, which is an agreement between the investigator, the participant and the scientific community, provides the background, objectives, design and organization of the trial. This is a document that is prepared way before participants are enrolled, and remains essentially unchanged unless for minor updates. Any major changes altering the direction of the trial need to be carefully justified; a rationale behind the changes should be clearly described. In clinical trials, an outcome is defined as a variable intended for comparison between groups in order to assess the efficacy or harm of an intervention (Chan, 2004). An outcome may be primary or secondary. A primary outcome, measured at the primary endpoint, is the variable that forms the basis of the study and is predetermined by the investigator at the design stage of the study. A ... Get more on HelpWriting.net ...
  • 6. Clinical Trials: A Kantian and Utilitarian Point of View... The first article is entitled "of mice but not men: problems of randomized clinical trials," is written by Samuel Hellman and Deborah S. Hellman discusses the issues of randomized medical testing and experiments on patients. The article describes the role of the personal physician and how the physician can take an ethical or unethical path of treating his/her patients. The relationship between the patient and physician is greatly emphasized because according to the article trust is very valuable in medicine especially when a patient's life is at risk. A Kantian and a Utilitarian view of randomized clinical trials are debated but the authors clearly steers towards a Kantian point of view. The author explains how randomized clinical... Show more content on Helpwriting.net ... The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society. Two completely different viewpoints of randomized clinical trials are given, article one is against the idea and article two is for it. Article one argues that when a patient sees a physician; the physician has the duty to provide the best treatment for that ... Get more on HelpWriting.net ...
  • 7. The Importance Of Tissue Engineering And Human Clinical... Tissue engineering has been an opportunity to restore the human condition from wounded to whole through the combination of biological, biochemical, and biomechanical concepts. Unlike traditional transplantation, tissue engineering and regenerative medicine uses a patient's own cells to fabricate new tissues which are then grafted back into his or her body. Of course, the goal is to apply the practices in the lab to the general public and to develop a new and more effective means to treat patients with severe tissue loss and/or organ failure. Each innovation requires a certain series of steps and regulations, from laboratory study to animal testing to human clinical trials. Unfortunately, a majority of tissue engineering trials fail to translate from lab to hospital because of a variety of issues, especially during clinical trials. According to Lanza et al., "Over the last decade, we have seen a number of tissue–engineered products that have either been abandoned following Phase I/II clinical trials, or have failed in Phase III clinical testing." The relatively high cost of these technologies and the lengthy experimentation lead to the question of how clinical trials are to be funded. For cases involving Investigational New Drugs (INDs), the U.S. Food and Drug Administration (FDA) allows sponsors of a research project to charge patients for the administration of investigational products during clinical studies. Traditionally, funding for clinical trials is provided by ... Get more on HelpWriting.net ...
  • 8. Clinical Trial Eligibility Criteria Clinical trials are the gold standard of experimental design to examine the effect of a clinical intervention on patients or populations. Recruiting targeted number of subjects in a timely manner is essential to the success of a clinical trial. Failure to enroll and retain expected number of participants could result in underpowered study (Page & Persch, 2013). One of the challenge for clinical trial recruitment is the clinical trial eligibility criteria are mostly written in free text, which cannot be easily interpreted by computer for automatic patient for the clinical trial. In order to utilize the electronic health record (EHR) system to match a patient to clinical trials, match patients to applicable clinical evidence and re–use of eligibility criteria from related clinical research studies on similar patients during the design of a new study, several eligibility criteria knowledge representations were developed(Weng, Tu, Sim, & Richesson, 2010), such as SAGE, Eligibility Rule Grammar and Ontology (EGRO) (Tu et al., 2011). Analysis of Common Eligibility Features (CEFs) (Boland & Weng, 2013) and clustering of similar eligibility criteria (Hao, Rusanov, Boland, & Weng, 2014; Luo, Yetisgen –Yildiz, & Weng, 2011) explored some applications of semantic similarity between clinical trial eligibility criteria. ... Show more content on Helpwriting.net ... It is the opposite of semantic similarity. Matching two clinical trial eligibility criteria can be seen as measuring the semantic distance between the two eligibility criteria documents. Matching a patient to a clinical trial can be seen as calculating the semantic distance between a clinical trial eligibility criteria document with a collection of medical documents of a ... Get more on HelpWriting.net ...
  • 9. Clinical Trials In Developing Countries Case Study Raye' Tabor November 15, 2017 Ethical Issues in Clinical Trials in Developing Countries Due to the lack of money but the high demand of need of specific regimens in developing countries, researchers from developed countries are allowed to conduct trials on those citizens. In this article, Baruch Brody argues against moral criticisms given towards clinical trials in developing countries. His three arguments are the subjects weren't treated unjustly (following an appropriate standard of justice), the subjects weren't coerced (in terms of any plausible interpretation of the word), and the subjects weren't being exploited (if they themselves gain access to the treatment after the study). While conducting the study, there are two groups:... Show more content on Helpwriting.net ... Lastly, Brody uses (for lack of a better term) a "legal loophole" to justify how those involved were not exploited. Critics believe since the treatments in the studies being conducted are not going to be available to those in the developing countries they are being tested in, the country is being exploited. To Brody, though, the issue does not lie in exploiting the country as a whole, but in exploiting those directly involved in the study. For him, this issue can be resolved by simply ensuring their future treatment. Of Brody's three arguments presented, the correction to exploitation is easily criticized. If we were to agree that the country as a whole cannot be considered when deciding whether or not exploitation is evident, and only focus on the participants, another issue arises. One can then say that those in the control group are being exploited, due to the lack of knowledge that they are not receiving the treatment being tested. Because the subjects agreed to participate on the basis that they would receive treatment, not giving them the treatment is the exact meaning of exploitation. Also, by being placed in the treatment group, they have not benefited from the study at all, making the treatment group the only subjects to not have been exploited. In response to this criticism, Brody explains that under the local standard of care, participants in these trials would not ... Get more on HelpWriting.net ...
  • 10. Process Of A Clinical Trial Working Title: TBD Authors: Aron Shapiro A search on clinicaltrials.gov for the term "retina" yields well over 800 on–going studies of alternative systems of drug delivery, gene therapy, stem cell treatments, imaging systems, and much more. While most retinal specialists are fully prepared to implement new techniques in the setting of a clinical trial, these new, sometimes invasive, protocols can seem daunting and scary to patients. To recruit subjects who will commit to a long–term study, it's vital to take the time to discuss the details of the trial in order to appropriately manage the patient's expectations. Starting Off Right Before the recruiting process begins, it's important for the investigator to "buy in" to the clinical rationale and approach: he or she must feel confident that the proposed intervention has meaningful potential in the treatment of the target disease. This belief can be based on preliminary studies, biological plausibility, and presence of a true unmet need. Without the investigator's commitment in the intervention at hand, it will be virtually impossible to recruit potential patients and come to an agreement with the patient that enrolling in a study is the most appropriate plan–of–action. If the investigator is enthusiastic about the potential of the therapy, the next step is deciding which patients are the most suitable candidates. The identification of ideal patients starts by matching candidates with the particular diagnosis and then ... Get more on HelpWriting.net ...
  • 11. Covance Leeds Clinical Trials For 25 Years Covance Leeds Clinical Trials The Covance UK Leeds Clinic has been conducting clinical trials for 25 years and has made quite the name for themselves with the world's leading medicinal companies. Because Covance Leeds does both Phase I and Phase II clinical trials, paid volunteers are accepted per clinical trial basis regardless of health. So healthy or patient, you can be paid to take part in their clinical trials. Getting to Know the Covance UK Leeds Clinic Established in 1986, Covance Clinical Research Unit at Leeds carries out Covance clinical trials for some of today's leading pharmaceutical and biotechnological companies. Covance Leeds Clinic works with these companies in Phase I and II testing such as drug absorption, reaction, ... Show more content on Helpwriting.net ... Although Covance clinical trials can carry some risk, you can trust the 25 years of experience that Covance UK has earned in safely conducting clinical trials. As well as having a team of medical experts to keep you healthy and safe, Covance UK also has the Research Ethics Committee and the UK Medicines and Healthcare products Regulatory Agency (MHRA) approve each Covance Leeds clinical trial before it starts to set up appropriate safeguards for all of their healthy and patient volunteers. Qualified doctors and nurses are on hand to monitor your safety at all times. The Covance UK Leeds Clinic Staying onsite for the duration of your Covance medical trial is mostly dependent upon the Covance clinical trial that you take a part in. Since a clinical trial can last from two nights to a month, the Leeds Clinic provides wonderful accommodations to all of their healthy and patient volunteers. These offers include satellite television, internet and wifi, a pool table, free arcade games, XBox 360 & PS3, board games, DVDs, a book library, daily newspapers, organized events (quizzes & bingo), quiet rooms, modern showers, 3 catered meals a day, and a smoking room (if allowed on your study). There are a few things you as a volunteer will have to bring in order to make your stay more comfortable. You should of course bring your own clothes and toiletries as well as ... Get more on HelpWriting.net ...
  • 12. Organizing A Global Clinical Trial Involving A New Serum... The topic of "organising a global clinical trial involving a new serum marker to detect the early onset of lung cancer" has numerous potential discussion points. Firstly, it is necessary to understand what is meant by "clinical trial". A clinical trial is any research or study which assigns human participants to one or more health related intervention3. These interventions are then evaluated to determine the effects on health outcomes, such as disease3. Since clinical trials are centred around human participants, human ethics underpin every aspect of the clinical trial. The aim of a clinical trial is to develop safe medical treatments and vaccines1, so human participation is essential to ensuring these drugs are safe and effective. In the ... Show more content on Helpwriting.net ... Global clinical trials are also necessary for rare diseases. This is because cases may be scattered across the globe, and to ensure enough participants are recruited to gain scientifically useful data, researchers are forced to look globally1. As such, increasing the number of global clinical trials has clear benefits to researchers and society. In addition to the advantages of ensuring a drug is safe in various populations, globalisation has wide reaching benefits. The greatest benefit to scientists and pharmaceutical companies is the reduced cost of conducting clinical trials in lower–income countries1. Clinical trials are driven primarily by the work of physicians, nurses and trial coordinators1, and in lower–income countries the salaries of these workers are far less than in high–income countries. The estimated cost of outsourcing clinical trials to clinics in these lower–income countries is between $1500USD and $2000USD2. This is substantially lower than in high–income countries. The added benefit to consumers of reduced clinical trial costs is the reduction in price of the trial drug. Globalisation of clinical trials shortens the period of time required to conduct clinical testing, which further reduces the costs of drugs2. This results from the increased ... Get more on HelpWriting.net ...
  • 13. Clinical Trials And Its Effects On The Public Health Care... Introduction Pharmacovigilance is "the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine related problem." Regulated in the US by the Food and Drug Administration (FDA) with the expectation of volunteer reporting by health care professionals (HCP) and mandatory reporting by drug developers/manufacturers, this field of study is essential in the improvement of patient outcomes and safety. Its peripheral importance lies in contributions to cost effectiveness and risk management in the public health care arena. Responsible and aggressive implementation of adverse event reporting procedures promote awareness and value to the importance of the identification of harmful effects of medication use. The stages of pharmacovigilance coincide with the stages of clinical trials. Each stage of a clinical trial has a pharmacovigilant component. The preclinical phase which is restricted to animal testing is the first stage of research and development that determines safety. Once a compound is determined to be safe in laboratory animals and has potential to be therapeutic in humans, it can be considered for Clinical Trials. Phase 1 of a clinical trial is primarily to evaluate a new compound's safety in general and therefore is conducted with less than 100 participants which are expected to be healthy. If the Phase 1 safety profile suggests a low risk factor for a drug, Phase 2 and 3 studies continue with the ... Get more on HelpWriting.net ...
  • 14. Grey's Anatomy Clinical Trial Participation Clinical Trial Participation In the popular television drama, Grey's Anatomy, the main stars conducted a series of clinical trials that introduced Seattle into a new form of research. After their trial called the "Shepard Method" grew into a success, the program's audience became aware of clinical trials in reality. In the previous years, clinical trials have evolved and made a big impact on society. However, there is controversy about whether or not one should take part in clinical trials. People should participate in clinical trials because they are safe, a way to earn money, a positive impact on the medical field, easy to perform in, and highly successful. A clinical trial is similar to a research study that is conducted for many reasons. ... Show more content on Helpwriting.net ... But, this is proven wrong because many studies do not consist of any long or hard tasks. According to the National Library of Medicine, a majority of trials require "minimal amounts of time and effort" ("Clinical Research"). One example of a research procedure is shown by Bridge, "right handed males aged 18 to 40 take part in a trial on the pain killing effects of Botox, which involves two outpatient visits." This case presents the low complexity of a trial; in this circumstance only two visits are needed. Also, the only qualifications needed to participate in this case include: being a middle–aged, right–handed male. A survey shows that studies are simple to take part in because the "most common discomfort is a headache from caffeine withdrawal" (Bridge). Bridge clarifies that studies do not involve many extreme responsibilities to be performed from the participant because the hardest task is to avoid drinking caffeine. A main reason for a trial to run smoothly and efficiently, without causing the patient to complete tough labor is due to the health professionals. The article titled Putting Yourself On Trial justifies, "hard work is carried out by our professional medical team, which leaves you free to relax and enjoy the facilities" (Bridge). Completing simple tasks is the key to participating in an easy clinical ... Get more on HelpWriting.net ...
  • 15. Clinical Trial and Joint Venture GENZYME/GELTEX PHARMACEUTICALS JOINT VENTURE In early 1997, Greg Phelps, EVP of Genzyme Corporation, met with members of a joint– venture negotiating team to develop proposed terms of a joint–venture agreement. The venture would combine capabilities of Genzyme and GelTex Pharmaceuticals to market GelTex's first product, RenaGel. GelTex was an early–stage biotech research company with two products in its pipeline. GelTex had neither the capital nor the marketing organization to launch RenaGel. Therefore, the company had been looking for a partner that would contribute cash and marketing expertise in exchange for a share of profits in a joint venture. Genzyme had revenues of $518 million in 1996, and had grown rapidly... Show more content on Helpwriting.net ... The drug was approved for sale in the United States in March 1991 to treat patients suffering moderate to severe symptoms of Gaucher's disease, a market of some 3,000 people. Two years later, the company launched a recombinant form of Ceredase and started to enter new markets–surgical, pharmaceutical, diagnostic, and genomic products–through strategic alliances, joint ventures, and acquisitions. Such diversity allowed Genzyme to play a leadership role in a broad range of cutting–edge technologies and therapies, according to Genzyme's chair, president, and CEO, Henri A. Termeer.2 The company's diversity came from its threea divisions–Genzyme General; Genzyme Tissue Repair; and a subsidiary, Genzyme Transgenics –each with its own common stock traded on the NASDAQ (Exhibit 1). The wide array of technologies provided Genzyme with an excellent platform for achieving breakthroughs in major unmet medical needs. Rather than concentrate efforts on the next big hit, however, the company had decided to manage its R&D like a portfolio by outsourcing innovations through partnerships. Genzyme's strategy was to supplement its internal R&D with strategic alliances with external ... Get more on HelpWriting.net ...
  • 16. Clinical Trials Are Medically Based Experiments 8CLINICAL TRIALS 8.1INTRODUCTION Clinical trials are medically based experiments undertaken on human subjects to systematically determine the effectiveness and/or safety of therapeutic interventions. Formal definitions of clinical trials are numerous, but they capture the concept of an organized, systematic study of human subjects in a treatment environment that is consistent.245 Studies are created to measure different things, such as determining whether a treatment is effective compared to a placebo or determining whether one treatment is more effective than another. Increasingly, the cost of therapy is also being added into the studies to create what are called cost effectiveness analyses, in which the effectiveness of various... Show more content on Helpwriting.net ... The Helsinki Declaration of 1964. The 1971 Guidelines by the US Department of Health Education and Welfare, codified into formal Federal regulations in 1974. The Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research is required reading for all researchers. This document provides the ethical underpinnings of most of the U.S. Federal regulations governing human research. The document sets out the difference between the practice of medicine and research, ethical principles including the principles of respect for individuals, beneficence and justice, and more specific the application of these principles to actual research. For example, the document discusses informed consent, the assessment of risks and benefits and the design of research, and the selection of subjects. The International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use guidance documents. Referred to usually as the International Conference on Harmonization, or ICH, this group developed international standards in the early 1990s that were adopted in large measure by the United States and once followed, permit the exportation of research results across international borders without the need for repetition or ... Get more on HelpWriting.net ...
  • 17. A Multistep Recruitment Strategy to a... Available online at www.sciencedirect.com Applied Nursing Research 23 (2010) 227– 232 www.elsevier.com/locate/apnr A multistep recruitment strategy to a participant–intensive clinical trial Kim Dupree Jones, PhD, RNCa,вЃЋ, Ann C. Reiner, RN, MN, OCNВ®b a Oregon Health & Science University, Schools of Nursing and Medicine, Portland, OR 97239–2941, USA b Oregon Health & Science University, School of Nursing, Portland, OR, USA Received 25 June 2008; revised 28 August 2008; accepted 2 September 2008 Abstract Adequate access to well –informed study participants is key to rapid recruitment and retention to randomized controlled clinical trials (RCTs). We describe a novel seven–step recruitment process for enrolling participants in... Show more content on Helpwriting.net ... Jones, A.C. Reiner / Applied Nursing Research 23 (2010) 227–232 employing traditional ways of recruiting. In FM RCTs, the most common way to recruit participants is through invitation letters mailed to potential participants who are patients in a rheumatology practice. Recruiting through this method, however, does not protect a study from high attrition; in one aerobic exercise study in patients with FM, attrition rates were as high as 67% (NГёrregaard, Lykkegaard, Mehlsen, & Danneskiod–SamsГёe, 1997). Another standard recruitment strategy is to employ a research assistant on site to wait for referrals from the FM provider. Appealing to referring clinicians to recommend patients to consider a study is also a commonly used strategy (Reisine, Fifield, & Winkelman, 2000; Veenhof, Dekker, Bijlsma, & van den Ende, 2005) but in our experience is less successful without immediate patient follow–up. There are several disadvantages, however, to all of these clinic–based recruiting approaches. One is that participants may believe that the research study is in the best interest of their clinical care. Another is that patients in a clinical setting may not have adequate time and energy to fully understand the study participant responsibilities or give informed consent due to the increasing length and complexity of consent forms. Consequently, participants may drop out when the study does not meet their expectations (e.g., they are randomized to the placebo group or they ... Get more on HelpWriting.net ...
  • 18. Registration Of Clinical Trial : Advantages,... Registration of Clinical Trial: Advantages, Disadvantages Industrial, and Consumer Perspective Introduction Registration of clinical trials has been a controversial issue for years. According to ICMJE, a clinical trial is any research project that prospectively allocates people or a group of individuals to intervention, with or without concurrent comparison or control groups, to study the cause and effect relationship between a health related, intervention and a health outcome. Health–related interventions are those used in the modification of biomedical or health–related outcomes such as drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and the... Show more content on Helpwriting.net ... The project intends to take the lead in setting international norms and standards for trial registration and reporting (World Health Organization). Additional the International Committee of Medical Journal Editors (ICMJE) made an announcement of a tough stance on trial registration. One regulation being that after 1 July 2005 trials that begin enrollment of patients must register in a public trials registry at or before the onset of enrollment to be considered for publication in those journals. Trials that began patient enrollment on or before 1 July 2005 must register before 13 September 2005 to be considered for publication Importance The need for trial registration received a lot of acknowledgment for years. However, it was not until in 2004 when the revelation that trial data on the harms of specific serotonin reuptake inhibitors in children went undisclosed that its urgency became especially evident. Legal action by the Attorney General of New York 's upon GlaxoSmithKline and the decision of medical journal editors not to publish any trial unless it is has been registered put emphasis on the importance of registering trials (Dyer). Considering that transparency in research and knowledge, sharing is now widely seen as a precondition for the success of the health research enterprise makes trial registries a valuable tool to help achieve this transparency. In the same way, advances in technology made research methodology evolve so are the Internet in making ... Get more on HelpWriting.net ...
  • 19. Clinical Trial Endpoints Case Topic: You are designing a clinical trial for a drug company. How would you identify study endpoints that are meaningful to patients? Statement of Problem: Treatment effectiveness has been defined as a clinically significant benefit to the patient, with the objective of the patient living for longer or better, or both, than if they did not receive the treatment (Wilson et.al., 2015). This measure of efficacy might be shown by symptomatic improvement, or improvement in established disease progression endpoints (Wilson et.al., 2015). Since clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics, the characteristics of the disease and ... Show more content on Helpwriting.net ... Finally, clinical trial endpoints and the standards to which they are held significantly impact the regulatory and approval process for new drug applications. References: 1. Casarett, D., Karlawish, J., Sankar, P., Hirschman, K., & Asch, D. A. (2001). Designing Pain Research from the Patient's Perspective: What Trial End Points Are Important to Patients with Chronic Pain? Pain Medicine,2(4), 309–316. doi:10.1046/j.1526–4637.2001.01041.x 2. Herzog, T. J., Armstrong, D. K., Brady, M. F., Coleman, R. L., Einstein, M. H., Monk, B. J., . . . Alvarez, R. D. (2014). Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper. Gynecologic Oncology,132(1), 8–17. doi: 10.1016/j.ygyno.2013.11.008 3. Minion, L. E., Coleman, R. L., Alvarez, R. D., & Herzog, T. J. (2016). Endpoints in clinical trials: What do patients consider important? A survey of the Ovarian Cancer National Alliance. Gynecologic Oncology,140(2), 193–198. doi: 10.1016/j.ygyno.2015.11.030 4. Wilson, M. K., Karakasis, K., & Oza, A. M. (2015). Outcomes and endpoints in trials of cancer treatment: the past, present, and future. The Lancet Oncology,16(1). ... Get more on HelpWriting.net ...
  • 20. Ethical Dilemma On Randomized Clinical Trials Ethical Dilemma on Randomized Clinical Trial Randomized clinical trial (RCT) is the most effective way of conducting research on the efficacy and safety of newly developed drugs and medical treatment for public consumption. Like most experiments, there are usually two groups in conducting an RCT: the placebo group and experimental group. In the placebo group, the subjects receive a placebo drug or a drug that is already available and is used to treat a particular disease and in the treatment group, the subject receives the newly developed drug or treatment. However, in the RCT, the subjects that agreed to participate in the clinical trial are randomly assigned in either placebo or experimental group in order to eliminate observer bias and distribute the subjects' variables evenly on all groups. Furthermore, RCT is either single–blinded or double–blinded. In single blinded RCT, the subjects cannot know if they are placed on placebo or experiment group. Moreover, the subject cannot know anything about the progress of the trial. As for the double–blinded RCT, both the subject and the physician–scientists who are conducting the trial do not know which subject are in which group and whether a particular treatment's progress. According to the Hellmans, because of the nature of RCT, physician–scientists are placed in a serious ethical bind that it poses to physician–scientists, therefore, we should abandon this practice altogether. In order to explain how this ethical dilemma ... Get more on HelpWriting.net ...
  • 21. Risks Associated With A Clinical Trial How a subject perceives the risks associated with a clinical trial is a critical piece of informed consent and has been shown to impact patients' willingness to participate in clinical research (Kim, Tanner, Friedman, Foster, & Bergeron, 2015; Monson, Parlour, Simcock, Fallowfield, & Jenkins, 2011). There are multiple items which can impact a patient's perception of risk including disease state, gender, ethnicity, age, and factual and subjective knowledge of clinical research. The impact disease state has on a patient's perception of risk varies with the type and severity of disease as well as the availability of alternate treatment. For example, patients view the discovery and development of new treatments for severe conditions as more important than the discovery and development of new treatments for mild or moderate conditions (Center for Information in Study on Clinical Research Participation (CISRP), 2015). This factor especially impactful in the research of oncology drugs where patients (often with severe conditions) are more inclined to participate the research of new treatments (Walsh & Sheridan, 2016). Because Prader–Willi syndrome is a currently incurable genetic disease with few treatments, this item is important for this study. The gender/sex of the patient may also impact his or her willingness to participate in a study. In cardiovascular prevention trials, "women perceived greater risk of harm and myocardial infarction" than men which resulted in women ... Get more on HelpWriting.net ...
  • 22. The Importance Of Post Clinical Trial Results In The... Background Information From 21 July 2014 it became compulsory to post clinical trial results in the European Clinical Trials Database (EudraCT) which is managed by the European Medicines Agency (EMA) and it is essential for clinical study information to be made more reachable and accessible. By saying 'Clinical Trial ' the agencies are referring to any trials on new drugs that are in preparation for a regulatory submission, drugs, devices or procedures on any medical interventions and any other investigations that involves of participants for research purposes, for example psychology studies. All of these clinical trials may generate numerous amounts of result or data. Traditionally only a few results were published in journals and they ... Show more content on Helpwriting.net ... This also avoids excessive research and expands the accessible evidence on an intervention. Four sets of information are needed: –Whether the trial has actually happened, which means it is necessary for the trial to be registered. Information such as the study protocol, analysis plan and possible completion date of the trial could be registered before the trial starts. This means the final result could be checked against the protocol and would be easier to find out about any 'non–published' trials. –Summary of the method and results – brief summary and result for every trial that was conducted. –Clinical Study Reports (CSR) – to see whether there were any amendments to the protocol during the course of the trial, which could mean that somebody has noticed something in the result and they want to change the analysis in a way that is more flattering. Often information on adverse events is very incompletely reported in journal articles but much more completed in CSR. Clinical Study Report (CSR) is a lengthy and comprehensive document that gives information in regards with the methods and results of a clinical trial. This document is submitted to regulatory by a company who is looking for approval to market a 'novel drug'. It is a source that addresses efficacy and safety. –Individual Patient Data (IPD) – this can be defined as the raw data from a clinical trial that has been treated to ... Get more on HelpWriting.net ...
  • 23. Issues of Clinical Trials in India by Vallinadh Karamcheti Clinical trials in INDIA– Legal issues By: Vallinadh Karamcheti Abstract: Clinical trials are conducted to ensure the safety and efficacy of the drug. They are conducted on the human subjects. Hence the clinical trials are liable to many legal aspects. Clinical trials are conducted in four phases. (Phase I, Phase II, Phase III, & Phase IV). All the phases of the clinical trials should comply with several legal aspects, as life of a person may be at risk if anything goes wrong with the clinical trials. They should comply with the Schedule Y of Drugs and Cosmetics Act, 1940, Drugs and Cosmetics (II Amendment Rules) Rules 2005, Good Clinical Practices guidelines, 2001 etc. What are clinical trials? Clinical trials are the tests conducted... Show more content on Helpwriting.net ... Pre–clinical trials includes Pharmacological testing to check that the drug do not produce any hazardous effects such as cardiac arrest, cardiac dysrhythmias, acute bronchoconstriction etc. Preliminary toxicological testing to eliminate genotoxicity and to determine the maximum non–toxic dose of the drug. As well as being checked regularly for weight loss and other gross changes, the animals so treated are at the end of the experiment to look for histological and biochemical evidence of tissue damage. Pharmacokinetic testing, including studies on the absorption, metabolism, distribution and elimination (ADME studies) in laboratory animals. Chemical and pharmaceutical development to assess the feasibility of large–scale synthesis and purification, to assess the stability of the compound under various conditions, and to develop a formulation suitable for clinical studies. Much of the work of preclinical development, especially that relating to safety issues, is done under a formal operating code, known as Good Laboratory Practice (GLP). The aim of GLP is to eliminate human error as far as possible, and to ensure the reliability of the data submitted to the regulatory authority, and laboratories are regularly monitored for compliance to GLP ... Get more on HelpWriting.net ...
  • 24. The Global Clinical Trial Is A Very Challenging Job The global clinical trial is a very challenging job; it involves strategic decision making which can affect drug development and approval process. Many factors should be considered in selecting countries, most common in feasibility studies include: the prevalence of the disease, regulatory requirement, patients' recruitment, experience clinical trial specialist availability, ethical issues, language barrier, and marketing strategy. In this report, we perform a thorough assessment of conducting clinical trials in countries such as Canada, Germany, Spain, Japan and the US. The criteria chosen for this assessment include disease prevalence, insurance coverage, patient enrollment rates, regulatory environment and finally costs associated with ... Show more content on Helpwriting.net ... Additionally, the rates of heart attack are 1.8 times higher among adults diagnosed with diabetes than those without a diagnosis. When compared with men, women of all ages diagnosed with T2DM have even a higher risk of heart disease (NIDKK, 2016). Why selection of Germany? According to traveler's digest, Germany's size is comparatively small to the state of California (2014). Despite its small size, Germany ranks amongst the worst for all things diabetes. As of 2008, 7.4 million (12% of the total population) adult citizens are plagued with diabetes in Germany with an additional 4.1 million citizens on the brink of having the condition with prediabetes. Type II diabetes accounts for about 80–90% of all diabetic cases in Germany. It 's also significant to note that 1/10 diabetes sufferers in Germany also have coronary heart disease (Novo Nordisk, 2008). Additionally, there have been a predicted 3 million undiagnosed cases of diabetes waiting to add to more startling statistics (Tenderich, 2011). When it comes to clinical research, it appears Germany has a legitimate presence and good rapport with industries that cater to healthcare. Germany's involvement in clinical studies far exceeds its demographics with a strong medical tradition as well as a ... Get more on HelpWriting.net ...
  • 25. Ethics of Offshoring: Novo Nordisk and Clinical Trials in... Ethics of Offshoring: Novo Nordisk and Clinical Trials In Emerging Economies Offshoring is a highly debatable topic throughout the country and the world. Many people base their opinions on different aspects of offshoring. Some people are against offshoring because they feel as if the working conditions in other countries aren't up to par and are unethical. Some people are against offshoring because they feel it is taking jobs away from people within their own country. Some people are for offshoring because they feel there is greater profit involved or that they can get harder workers in other countries. No matter what side of the debate, everyone can agree on a few things like there needs to be better standards for working conditions, ... Show more content on Helpwriting.net ... Another question that needs to be addressed is if trials are conducted in an emerging economy, how should they be managed and which standards should apply? I think medical ethics is a big issue when it comes to trials being conducted in an emerging economy. One famous incident of this was the Tuskegee syphilis study. This study left 400 African Americans untreated in order to research how they obtained the disease. The cure for syphilis, penicillin, had already been found in the 1940s. To prevent this from happening again, professional medical organizations developed guidelines and principles of ethics to guide their research, notably the Helsinki Declaration. I believe Novo Nordisk does a great job of adhering to these guidelines by putting safety measures in place. Emerging economies like India and China are attractive places to have clinical trials because of how much cheaper it is, the willingness to try new things as an emerging economy, and because a possible lack of standards. Novo Nordisk only conduct trials in countries where they have affiliates with necessary competence to arrange and monitor the trials. Also, they conduct clinical trials globally to test the safety and efficacy of new drug candidates in order to obtain global marketing authorization. These trials always have the same standards at all trial sites. The standards in ... Get more on HelpWriting.net ...
  • 26. Animal Models And Clinical Trials (WY Mak et. Al, 2014) discusses the concerns of the fact that many drugs that are successful in animal trials are not successful in clinical trials, most specifically, drugs used in cancer treatments. Animal models have been an important factor in the testing of a new drug before it is used in clinical trials, but many drugs that are approved in animal models are not successful in human models. It has been shown that 85% of early clinical trials for novel drugs are not successful and from the remaining 15%, only half are approved for human use. The reason there is a difference in results between animal models and clinical trials have to do with the inability of animals to identically mimic human body functions. An example of a trial that had a difference in results is the TGN1412 trial. TGN1412 was a drug used to treat diseases such as MS, rheumatoid arthritis, and certain cancers. Before used in clinical trials, this drug was first tested in mice. There were no complications shown in mice that would indicate complications in humans. Humans in clinical trials were given a dose 500 times lower than the dose given to mice and it resulted in catastrophic organ failure. Another study involving IPI–296 in patients with advanced chondrosarcoma was ended early due to the fact that it had no effect shown in clinical trials. When IPI–296 was used on mice, they were shown to have an increase in survival rate. This showed that the effects of the drug on animal models was different ... Get more on HelpWriting.net ...
  • 27. Clinical Trials These events are just a few examples of the ways that medical companies might take advantage of people in developing countries in order to further their research more quickly and increase their profit. An ever increasing number of trials are being held overseas; in 2008, nearly 65 percent of trials on products registered from within the United Sates were conducted in other countries. With this growth, the need to make sure that vulnerable communities are not exploited also increases; while the FDA did inspect roughly two percent of domestic trials, the number of overseas trials which were inspected was less than half that number. (Wechsler, 2011) These are worrisome examples and statistics which all need to be addressed as the medical community... Show more content on Helpwriting.net ... A group of researchers sought to get a closer look at how clinical trials were carried out by talking to nurses who were working with drug trials. While participants in this study were all located in the United States, their experiences are pertinent when considering the ethical concerns involved in all clinical trials. The nurses who participated voiced a variety of concerns while they were working with clinical trials. They reported that despite consent being voluntary, and patients being told that they could discontinue a study at any time, there were some conflicts between this and the actual practice. Nurses who lost subjects in the study were often penalized and reprimanded, seemingly encouraged to sacrifice the patient's rights and desires in order to keep them in the trial. They also talked about how higher ups, who might be in charge of funding or the legalities, are often out of touch with what is actually ideal in the practical sense, rather than the bottom line. One nurse gave the example of how legally, one official might want the consent form to be three pages long, another might want it cut down considerably, and the nurse, who is actually performing the study, wants a consent form which is both thorough as to protect the patient, but concise and clear enough to be easily understood by the patient. Furthermore, nurses might be asked about their own opinions by their patients, which leaves them in a difficult situation where they could be using their authority to pressure someone into a study. All of these are difficult things to balance, and very valid concerns brought forward by individals with hands on knowledge of these trials. (DeBruin, Fisher & Liaschenko, ... Get more on HelpWriting.net ...
  • 28. The Total Number Of Clinical Trials The total number of clinical trials in Portugal has recently experienced a reduction in a 12 13worrying trend revealing a significant loss of competitiveness in this field. Between 2006 and 142012 the number of trials decreased by 26%, i.e. from 160 to 118 studies. The trough in these 16numbers only arrived in 2011, when just 88 studies took place. This trend shall only either 17 18prevent or hinder the achievement of social and/or political benefits, such as the improvement 19 20of medical and supportive care, job creation, the organization of health facilities and early 21access to innovative medicines and research methodologies 1. The reasons for this decrease 22 23stem from numerous aspects, including the cost and difficulties of attracting volunteers to 24 25participate in such studies. 26 27 28The effectiveness of a clinical trial depends on the size of its sample, sample homogeneity, 29 30the similarity of the results and the differences among the mean values for each group. In this 31kind of study, it proves very difficult to achieve the minimum participant numbers required to 32 33obtain the ideal sample size. This situation occurs for various reasons including the study cost, 34 35the low frequency of certain diseases, uncertainty about the effects of treatment, and among 36others 2. 37 38
  • 29. 39 40Considering this framework, certain actions might be implemented in order to reverse this 41scenario. Some techniques and marketing strategies ... Get more on HelpWriting.net ...
  • 30. The Ethics Of The Clinical Trials In recent years, the number of clinical trials increased significantly. With an increasing number of clinical trials, the ethical issues related to clinical trials have also increased. Furthermore, the ethics of the clinical trials were violated on several occasions in last few decades. Nazi experiments with World War II initiated the world leaders to implement a code of conduct that protects the autonomy of theclinical trial subjects. Therefore, the Nuremberg Code was initiated in the year of 1949. However, this Code failed to protect the human subjects in clinical trials. Tuskegee syphilis trial was one of the few incidents that were exposed in front of the entire country. The regulatory agencies and the government then realized that there should be better regulations to protect the human subjects in the clinical trials. A series of codes and regulations were established to protect the subjects in the clinical trial after the Tuskegee incident. The Belmont report (1979), International Conference on Harmonization guideline for Good Clinical Practice (1996), the Declaration of Helsinki (2000), and CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) are the main guidelines in recent years. There are also federal regulations to protect human subjects in the clinical trials. They are USCFR Title21 Part 50, 56 (Protection of Human Subjects and Institutional Review Boards, 1991), and USCFR Title 46 (The Common Rule, 1981). These federal ... Get more on HelpWriting.net ...
  • 31. Taking a Look at Clinical Trials Every medical innovation starts with an idea or vision, and goes through several developmental stages, namely, basic research, translational research and clinical research before being able to market the treatment. (4) This treatment can be a drug, a medical device, a vaccine, a blood product or gene therapy. (3) The basic research is done in a laboratory, where cell function is studied, and it is determined under what conditions the treatment could cause cells to function more effectively. The treatment is then tested in animals to see the effect, and to test possible toxicity. Once the treatment has been named safe for use in animals, it can then be tested in humans. (4) Clinical research, or clinical trials, involves the testing of the treatment in human volunteers, working towards the approval of the treatment to be marketed. (3) The research that bridges the gap between studies done in the laboratory and clinical trials is then known as translational research. (4) The main purpose of a clinical trial is to determine if the treatment is safe and effective for human use, and is required by the Food and Drug Administration (FDA) before a treatment can be approved. There are, however, other reasons these trials are performed. They can be used to compare the new treatment to an already existing one to determine which is more effective, and to determine different ways in which to use current treatments in order for them to be most effective, easiest to use and provide the ... Get more on HelpWriting.net ...
  • 32. Case Study Of The KIWI Clinical Trial subjects 6–11 years old (ppFEV1=95.8% at baseline) and a more progressed disease state in the adult subjects (ppFEV1 = 64.5% at baseline).(36) The KIWI clinical trial was a two–part, open–label, phase 3 study to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of ivacaftor in CF patients between two and five years old with at least one CFTR gating mutation. Results from this study expanded the use of ivacaftor to patients as young as two years old (Table 1).(15) Despite in vitro results demonstrating an increased Isc in F508del–CFTR expressing FRT and HBE cells upon forskolin stimulation,(22) no therapeutic benefit was observed in CF patients homozygous for F508del–CFTR. The DISCOVER trial was a phase 2 study to test ... Show more content on Helpwriting.net ... Part 2 assessed multiple ascending doses of D9–ivacaftor (75mg, 150mg, and 225mg), each administered daily after a high–fat meal for 7 days, compared to placebo.(68) Results presented during the 39th European Cystic Fibrosis Conference demonstrated improved PK of D9–ivacaftor compared to KalydecoВ®, including a 40% increase in half–life (D9–ivacaftor t1/2 of ~15hrs; KalydecoВ® t1/2 of ~11hrs), reduced clearance rate (D9–ivacaftor CL/F of 3.8L/hr vs. KalydecoВ® CL/F of 13.3L/hr), approximately 3–fold increase in exposure (D9–ivacaftor AUC0–inf of 44,916ng*hr /mL vs. KalydecoВ® AUC0–inf of 12,925ng*hr/mL), and approximately 3–fold increase in plasma concentrations at 24–hours (D9–ivacaftor C24hrs of 712ng/mL vs. KalydecoВ® C24hrs of 169ng/mL). Data shown here are for 150mg doses of both D9–ivacaftor and KalydecoВ®.(14, 26, 77) The improved PK profile of D9–ivacaftor along with a safety profile comparable to that of KalydecoВ® has allowed progression of D9–ivacaftor into a phase 2 clinical trial to evaluate its safety and efficacy in CF patients with CFTR gating mutations.(69) QBW–251 QBW–251 is a CFTR potentiator developed by Novartis Pharmaceuticals Inc. In vitro results showed QBW–251 to be an effective potentiator for CFTR gating mutations, including F508del–CFTR. Promising in vitro results led to the initiation of a ... Get more on HelpWriting.net ...
  • 33. The New Eu Regulation For Clinical Trials The new EU Regulation for clinical trials (EU Regulation 536/2014) is expected to be implemented in May 2016. This governs research on 'investigational medicinal products' –which could be new medicines or off license use of an authorised product. Whilst it is widely recognised that clinical trials are needed to develop new medicines, they also lead to an improvement in medical care more generally. The new regulation aims to remove the barriers to clinical research across Europe by– 1. Speeding up of the process for authorising new clinical trials and reducing the administrative burden associated with the conduct of these studies. 2. Developing a single EU portal for applications, allowing all member states to participate, which should allow tightly defined subgroups (i.e based on genomics) to be recruited in adequate numbers. There will also be an EU database for safety reporting, preventing researchers from having to submit largely identical information on the conduct of the study separately to various national bodies. 3. Increasing the number of applications to carry out clinical trials 4. Reducing costs and delays associated with launching a clinical trial 5. Reducing the amount of regulation for trials of medicines which are already authorised and which pose only minimal risk compared to normal clinical practice 6. Formally recognising co–sponsorship, facilitating NHS/University cooperation. 7. Encouraging greater transparency in trial milestones and in the ... Get more on HelpWriting.net ...
  • 34. Clinical Trials Regulations Clinical trials regulations aim to create an environment that is favorable for conducting clinical trials, with the highest standards of patient safety. Guidance documents have been issued by the regulatory departments to assist in the interpretation of policies and regulations and to ensure a uniform application of the legislations on clinical trials. Although regulatory departments in Canada, U.S., and Europe, follow the same principles to ensure the safety and wellbeing of the research participants and the integrity of the clinical research, their regulations for conducting clinical trials may have differences that need to be considered when sponsors are conducting multisite international trials. The variations in the regulatory requirements ... Get more on HelpWriting.net ...
  • 35. Globalization Of Clinical Trials And The Pharmaceutical... Name; Layth Al–Kinani, Globalization of clinical trials, Globalization has been adopted in many industries, in the pharmaceutical world, efforts around globalizing clinical trials into emerging markets have increased significantly. Noticeably there is increase in numbers of trials in areas like Asia Pacific, Central and eastern Europe, Latin America, and Middle East. Since 2002, 15% annual growth has been observed in the number of active FDA– regulated investigators bases outside the United State, while the number of U.S. based investigators has decreased by 5.5%. One explanation for this dramatic shift in the location of clinical trials is that, the pharmaceutical companies, realized the coast saving effect of conducting trials in developing countries, as affected by the lower salaries of physicians, nurses, and study coordinators in developing countries; a reason for moving phase 2 and 3 trials to places such as India and South America. Another important factor, is the large pool of potential research participants, provides opportunities to accelerate recruitment. Furthermore, what also attract the pharmaceutical companies to conduct their trails in developing countries is the less regulatory barriers for drug approval, in which the population size alone, offers the promise of expanding markets. Global trials are also necessary to find patients for rare disease studies, and in response to the spread of Western diseases such as heart disease and cancer. Outsourcing of ... Get more on HelpWriting.net ...
  • 36. Clinical Trials And The Medical Field Clinical trials are research processes that test the safety and effectiveness of various medical treatments using ethical means ("What are Clinical Trials"). They are performed to discover new, effective, and practical cures for many conditions including cancers. Whenever a new possible drug or potential cure is introduced into the medical field, it enters the clinical process in order to be analyzed and assessed for possible flaws and to maximize effectiveness. Clinical trials are essential to development in medicine because of their capability to discover new and more efficient cures for serious conditions and to improve on past solutions to make them easier and faster to perform. The impact of clinical trials in the medical field has ... Show more content on Helpwriting.net ... There are many different forms of clinical trials, each designed for separate medical purposes. The most common form of a clinical trial is a treatment trial, designed for cancer patients. This trial is designed to test the safety and effectiveness of new treatments ("Types and Phases of Clinical Trials"). This type of research is very prevalent in medicine and is used often to discover new possible cures. Diagnostic trials analyze new processes or technology that can aid in diagnosing forms of cancer with more ease and in a more accurate way. They help develop newer technology which can allow cancers to be detected more efficiently. Similarly, there are also screening trials which examine new technology to diagnose cancers earlier than previous methods. They are a form of diagnostic trials which can help spot cancers in earlier phases to prevent metastasis and allowing for proper treatment to be administered as soon as possible. In addition, there are prevention trials which investigate new processes to prevent cancers from originating in the first place. These trials try new methods and products to avert healthy citizens from developing serious conditions. Various trials are used for different purposes so the proper cure or method of prevention can be developed for a target group or sample. A clinical trial is designed by scientists in order to test the impact of ... Get more on HelpWriting.net ...
  • 37. Clinical Trials : Pediatric Cancer I)Introduction 1.Pediatric cancer 1)Approximately 70% of children diagnosed with cancer in the United States are cured, with a 5–year event–free survival rate of 80%1 2)Pediatric cancer is relatively rare – around 12,000 new cases diagnosed each year in the United States1 3)Pediatric oncology trials typically have high rates of accrual2 1.High accrual must be balanced with ethical treatment2 2.Overall goal is "optimal recruitment", which focuses on allowing families to make informed decisions2 4)Drugs are typically tested and approved in the adult population before being introduced to children3 1.Children are pharmacologically different than adults, thus a need exists for pediatric clinical trials – possibility of different adverse event profile, etc.3 2.Challenges involving pediatric cancer trials 1)Ethics of phase I trials in children 1.Definition of phase I trial (i)Purpose is to determine the safety (maximum tolerated dose), toxicity, and pharmacokinetics4 (ii)Phase I trials do not assess efficacy of the drug4 2.Safety of phase I trials (i)Treatment–related mortality rate of 0.5%4 (ii)Overall well–tolerated – only 25% of patients typically experience a grade 3 or higher toxicity4 3.Understanding of risks and benefits of phase I trial (i)Phase I trials can involve toxicity and only provide a minimal chance of direct benefit to the child – 6.8% for single novel agent and 20.1% for novel agent/known anti–cancer drug combination4 (ii)Potential benefits ... Get more on HelpWriting.net ...
  • 38. The Alliance For Clinical Trials The Alliance for Clinical Trials in Oncology is a collaborative effort that is committed to developing and conducting clinical trials to reduce the impact of cancer in patients from all over the world. In recent years this group was formed by three different cooperative groups creating a strategic alliance by combining forces to provide the best services for customers. The customer base in this industry is patients diagnosed with cancer who are seeking cutting edge and experimental treatment options. There are over 10,000 cancer specialists that collaborate in this mission to discover, validate and disseminate effective strategies for the prevention and treatment of cancer. It is important to conduct these clinical trials to save the... Show more content on Helpwriting.net ... Another way that clinical trials are sponsored within the Alliance for Clinical Trials in Oncology is through pharmaceutical companies such as Novartis, Celegene, Exelixis, etc. This creates an entirely different route for value analysis, although this is done on the pharmaceutical company side as they are sponsoring the Alliance to conduct the trials. The pharmaceutical companies tend to ask for more in–depth cleaning of the data so priorities can differ from that of the Alliance sponsored trials. I work on trials that are Alliance funded but I have spent most of my time within Mayo Clinic's Cancer Center working on industry sponsored trials. I recently worked on a Novartis funded trial that developed a drug undergoing FDA approval to treat patients diagnosed with Acute Myeloid Leukemia. Supply Chain The first step in developing a clinical trial is the doctor's idea for a new treatment. Once it is determined to be scientifically viable and after several committee meetings, a protocol is developed. A protocol is the official playbook or system of rules governing each step of treatment or intervention from beginning to end. The protocol also explains the history of the disease and the treatment drug being used in the trial. Also discussed are the primary endpoint and all endpoints thereafter and lays out the statistical considerations before the trial begins. This is a very intricate part of creating clinical trials ... Get more on HelpWriting.net ...
  • 39. Outsourcing of Clinical Trials to Developing Countries This paper explores outsourcing of clinical trials to developing countries focusing on current trend and providing brief overview of the clinical trials. The paper covers major reasons for outsourcing of trials to developing countries especially focusing on India with ethical and scientific concerns raised in conduct of clinical trials at foreign sites, throwing a light on growing career opportunities in developing countries and steps for ethical conduct. Introduction: Clinical Trial Outsourcing: Global Drug and Medical Device makers based in developed countries are now focusing on developing countries to carry out their clinical trials. These players (pharmaceutical and device makers) have embraced outsourcing as a core ... Show more content on Helpwriting.net ... Clinical Trials are used to determine whether new drugs or treatments are both safe and effective. A clinical trial that is regulated by the U.S. Food and Drug Administration (FDA) involves drug, biologic or medical device and fall into four phases each having different goals and designed to answer specific questions. The four different phases involved in clinical trials are: Phase I: These studies are designed to test the safety of treatment. In detail, these studies are conducted to determine metabolic and pharmacologic actions of interventions, the safety in human subjects and also to determine some evidence on efficacy. Phase I studies are conducted commonly in healthy volunteers; however, there are some exceptions where studies are performed on actual patient population (e.g., cancer therapies). This phase studies involve 20–100 subjects. Phase II: These studies are conducted to test effectiveness of treatment and identify common side effects along with continuous assessment of safety. These studies are conducted in patients who suffer from the condition which the drugs are intended to treat. This phase is involves several hundred subjects. Phase III: Phase III trials are designed to confirm whether the interventions are ... Get more on HelpWriting.net ...
  • 40. The Benefits Of Incentives For Clinical Trial Participation In the Product factor, the "Relevance of the product" presents the highest mean (4.217) and 6the "Method of data collection" variable the lowest (3,646). The "Product" dimension spans 7 8innovation, relevance and the testing methodology; the mean for this factor (4.007) ranks it as 9of intermediate importance in comparison with other factors. 11 12 13In the Incentives factor, the aspect "To have access to free examinations" gains the highest 14mean value (4.239) with the "Payment/financial incentives" variable presenting the lowest 16(4.024). The factor "Incentives" derives its name from grouping variables such as the 17 18opportunity to receive free health care, financial incentives and other incentives (offers, 19 20samples, vouchers, etc.); its mean score (4.114) turns out one of the highest and thereby 21emphasising the influence of incentives to clinical trial participation. 22 23 24 25 26Contact forms and communication tools 27 28 29 30Questionnaire analysis allowed us to infer that higher education students prefer the 31Internet/Social Networks/Blogs (86%) as a means of contact for raising awareness and/or 32 33participating in a clinical trial; however, that health professionals attain a considerable
  • 41. 34 35percentage (73%), as does email (68%), is also noteworthy. When asked about the 36media/tools that might increase their interest and/or participation in clinical trials or ... Get more on HelpWriting.net ...