Integrate eConsent PR-03_03 August.pdf
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This should be included in site-selection questionnaires, and checklists should be in place to help identify any challenges to eConsent adoption concerning experience, patient population, SOPs, technology, and connectivity.
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Embrace different country strategies for eConsent
Integrate eConsent in trial planning
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Recruitment & Retention: Breaking Down the Barriers to eConsent Adoption
Provided by ACRP's Clinical Researcher Magazine. Original at https://www.acrpnet.org/2017/04/01/recruitment-retention-breaking-barriers-econsent-adoption/
For more information on electronic informed consent visit www.crfhealth.com
eConsent: Five (5) Key Areas of Preparation
Site recruitment and retention of an adequate study population remains a major determinant of the success of a clinical trial. A recent survey to gather opinions on informed consent related to participant understanding, subject recruitment, and retention from 105 respondents' across site-based roles revealed 5 key areas that all sites should consider when preparing an eConsent.
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· Executive Summary· Summary of RecommendationWith the vis.docx
· Executive Summary
· Summary of Recommendation
With the vision of Panther Memorial Hospital in mind and their patients’ ease of accessibility to their health plans we recommend the development and implementation of a patient portal system constructed through the organization’s internal resources. From our feasibility matrix we found that weighted score of an internally created patient portal is higher than a commercial bought one; 89.25 vs 63.75. Per the finance department, this patient portal system is projected to yield a positive return of $400,000 annually over a 10 year lifespan with a payback of 4 years. There will be considerable savings in administrative costs, office supplies, and employee wages due to less paperwork and less face-to-face interaction at the hospital’s office; savings are projected to be 50%. Not only does Panther Memorial Hospital save in cost of operations but their quality of care is also improved for their patients through faster and more efficient management of care. The most positive outcome of this patient portal is the improvement of care and satisfaction for the patients, increase revenue, and a decrease in administrative cost.
· Summary of Problems, Opportunities, and Directives
The problems associated with patient to healthcare provider and patient to hospital hinders the fluidity of care for the patient. Paying medical bills through mail slows the collection of service render for the organization and may also cause problems if lost through the mailing process. Getting in touch with your primary care doctor when questions and concerns arise will have to go through a hospital operator lowering quality of care. Scheduling appointment will have to been done through office visits or by phone which problems may arise through miscommunication between patient and loss of written appointment dates. To view the results to tests, examinations, and procedures are limited to request and face-to-face communication with a healthcare provider. Refilling prescriptions is to slow due to the process of going to the hospital and having the provider write out another prescription. Personal insurance updates and adjust are slow and hinder due to the process of changing it at the administrative desk or through the hospital operator. Personal reminder are to slow through mail and phone which could get lost or missed. Registration and patient history are hard to obtain and may cause confusion for the patient of their plan of care. With all of these problems associated with patient to provider and patient to hospital there are opportunities for improvement through the creation of a patient portal system. The patient portal system will be a web-based applications that enables patients to access important information, conduct transactions of payment, and communicate with healthcare providers.
· Brief Statement of System Improvement Objectives
We established that some of our system objectives would be decreasing the time required f.
online food delivery system projects.docx
Rapid technological advancements have disrupted multiple sectors, including communication, banking, and business. Before the Web's advent, businesses were confronting obstacles in connecting with the customers, boosting service speed, and monitoring the business climate. The Web bridged the gap and played a crucial role in transforming the business climate completely. Also, emerging technological trends are forcing companies to adopt and integrate new technologies to improve customer experience.
Though technology disrupted conventional business practices, it also empowered small businesses to strive to broaden their horizons. The feeders attempt to leverage the Web's potential for bridging the gap between customers and business. Big players like Uber Eats have adopted technologies that quickly address and resolve customer's issues. Feeders.com is an effort to boost the capabilities of a newly launched restaurant that provides online food delivery services. Feeders currently are being operated in a single city. They don't have much muscle in allocating massive sums of money for improving customer experience, and their complaint management is also incapable of managing compliments quickly. The venture is in infancy; therefore, the quick attention to complaints can provide a competitive advantage. Also, having a well-functioning complaint management system can facilitate a healthy flow of information within the organization.
Feeders will integrate an online complaint management system in the form of a portal on its site. With the site, users will be able to provide feedback related to the taste, food delivery, and any other issues. The integrated mechanism, then, automatically sorts the complaints. Moreover, the constructed portal will serve as a bridge between customers and the restaurant staff. Presently, the team manages complaints manually, which consumes a considerable amount of time.
The website of the restaurant is also not upgraded. So, the team is required to redesign the site and in order to improve its user experience. The program will automatically schedule the complaints to notify the right person. Proven and time-tested methods were utilized in the design and development of feeders.com. Languages like HTML, CSS, PHP, and MySQL are widely popular languages that are commonly used to execute such operations.
To execute the project on time with no errors, a significant amount of attention has been given to each and every phase of the project. Effective project management, neat and clean coding, excellent test planning, and detailed documentation helped the team deliver a high-quality, fully functioning web portal.
DataArt Healthcare & Life Sciences
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Embrace different country strategies for eConsent
Integrate eConsent in trial planning
Optimize informed consent form digitization timelines
Train and communicate
Build a monitor advocacy program
Recruitment & Retention: Breaking Down the Barriers to eConsent Adoption
Provided by ACRP's Clinical Researcher Magazine. Original at https://www.acrpnet.org/2017/04/01/recruitment-retention-breaking-barriers-econsent-adoption/
For more information on electronic informed consent visit www.crfhealth.com
eConsent: Five (5) Key Areas of Preparation
Site recruitment and retention of an adequate study population remains a major determinant of the success of a clinical trial. A recent survey to gather opinions on informed consent related to participant understanding, subject recruitment, and retention from 105 respondents' across site-based roles revealed 5 key areas that all sites should consider when preparing an eConsent.
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A collaboration between Cognizant, the New England Healthcare Exchange Network and Informatics In Context is demonstrating how a real-time prior authorization (PA) system for medical and administrative processes saves time and money.
· Executive Summary· Summary of RecommendationWith the vis.docx
· Executive Summary
· Summary of Recommendation
With the vision of Panther Memorial Hospital in mind and their patients’ ease of accessibility to their health plans we recommend the development and implementation of a patient portal system constructed through the organization’s internal resources. From our feasibility matrix we found that weighted score of an internally created patient portal is higher than a commercial bought one; 89.25 vs 63.75. Per the finance department, this patient portal system is projected to yield a positive return of $400,000 annually over a 10 year lifespan with a payback of 4 years. There will be considerable savings in administrative costs, office supplies, and employee wages due to less paperwork and less face-to-face interaction at the hospital’s office; savings are projected to be 50%. Not only does Panther Memorial Hospital save in cost of operations but their quality of care is also improved for their patients through faster and more efficient management of care. The most positive outcome of this patient portal is the improvement of care and satisfaction for the patients, increase revenue, and a decrease in administrative cost.
· Summary of Problems, Opportunities, and Directives
The problems associated with patient to healthcare provider and patient to hospital hinders the fluidity of care for the patient. Paying medical bills through mail slows the collection of service render for the organization and may also cause problems if lost through the mailing process. Getting in touch with your primary care doctor when questions and concerns arise will have to go through a hospital operator lowering quality of care. Scheduling appointment will have to been done through office visits or by phone which problems may arise through miscommunication between patient and loss of written appointment dates. To view the results to tests, examinations, and procedures are limited to request and face-to-face communication with a healthcare provider. Refilling prescriptions is to slow due to the process of going to the hospital and having the provider write out another prescription. Personal insurance updates and adjust are slow and hinder due to the process of changing it at the administrative desk or through the hospital operator. Personal reminder are to slow through mail and phone which could get lost or missed. Registration and patient history are hard to obtain and may cause confusion for the patient of their plan of care. With all of these problems associated with patient to provider and patient to hospital there are opportunities for improvement through the creation of a patient portal system. The patient portal system will be a web-based applications that enables patients to access important information, conduct transactions of payment, and communicate with healthcare providers.
· Brief Statement of System Improvement Objectives
We established that some of our system objectives would be decreasing the time required f.
online food delivery system projects.docx
Rapid technological advancements have disrupted multiple sectors, including communication, banking, and business. Before the Web's advent, businesses were confronting obstacles in connecting with the customers, boosting service speed, and monitoring the business climate. The Web bridged the gap and played a crucial role in transforming the business climate completely. Also, emerging technological trends are forcing companies to adopt and integrate new technologies to improve customer experience.
Though technology disrupted conventional business practices, it also empowered small businesses to strive to broaden their horizons. The feeders attempt to leverage the Web's potential for bridging the gap between customers and business. Big players like Uber Eats have adopted technologies that quickly address and resolve customer's issues. Feeders.com is an effort to boost the capabilities of a newly launched restaurant that provides online food delivery services. Feeders currently are being operated in a single city. They don't have much muscle in allocating massive sums of money for improving customer experience, and their complaint management is also incapable of managing compliments quickly. The venture is in infancy; therefore, the quick attention to complaints can provide a competitive advantage. Also, having a well-functioning complaint management system can facilitate a healthy flow of information within the organization.
Feeders will integrate an online complaint management system in the form of a portal on its site. With the site, users will be able to provide feedback related to the taste, food delivery, and any other issues. The integrated mechanism, then, automatically sorts the complaints. Moreover, the constructed portal will serve as a bridge between customers and the restaurant staff. Presently, the team manages complaints manually, which consumes a considerable amount of time.
The website of the restaurant is also not upgraded. So, the team is required to redesign the site and in order to improve its user experience. The program will automatically schedule the complaints to notify the right person. Proven and time-tested methods were utilized in the design and development of feeders.com. Languages like HTML, CSS, PHP, and MySQL are widely popular languages that are commonly used to execute such operations.
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1) Identify best practices and learnings from how a large integrated health system is driving a multi-year digital transformation roadmap
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DeactivatedKelie Hein 3 posts ReTopic 1 DQ 1Two GCU lib.docx
Deactivated
Kelie Hein
3 posts
Re:Topic 1 DQ 1
Two GCU library scholarly databases that will help me find the best research articles for my proposal are two databases that I appreciate, and currently use often: CINAHL Complete and PubMed. I like CINAHL Complete because it is quite specific to nursing. It also provides many full text articles free of charge, which is unfortunately not that common. Some databases provide only abstracts, and some require one to purchase the article (which can be 50 dollars!). I like PubMed because it has a wide array of health science articles that are peer-reviewed, but often have language that is easier to understand. PubMed is also quite user friendly.
These two databases are better than Google Scholar and/or a general internet search, for several reasons. While Google Scholar provides scholarly articles, it can sometimes be difficult to limit the search. Inexperienced users an easily become overwhelmed with the amount of data the search returns. A general internet search is not only daunting in terms of qualified research, but can be dangerous as well: Wikipedia sources, the evil of internet research, are often returned with general internet searches. Anyone can post on Wikipedia (and the internet in general). Scholarly databases are the safe way to go: safe for the researcher, and safe for the patients under the researcher’s
1
3
Strategies That Facilitate Influencing Power
AcelRx Pharmaceuticals Inc Company
STRATEGIES THAT FACILITATE INFLUENCING POWER
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Strategies to Adapt Organizational Change
To adopt the online marketing and networking with customers then the Acel Rx Pharmaceuticals Inc. has to undergo some organizational change. Though the internet is the Internet could enable profound changes in the nature and structure of the healthcare industry and, ultimately, the delivery of healthcare services its adaptions should be strategic. First, there is need to carry out the change in phases with the start-up phase being clarifying the expectations and roles, assessing readiness, contracts and getting buy-in. In this phase is usually where the relationship between you (the initial change agent) and your client starts, whether you are an external or internal consultant. This means that Acel has to establish who its clients actually are, define the project conduct field research on the opinions of the customers after which they have to make the customers feel the problem at hand and the need to adopt this new technology which is aimed at making things better. It is important that the change agent should have good communication skills both verbal and non-verbal and a good listener.
Second in line is a jo.
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Contact info@trialjoin.com for more information about patient recruitment help, obtaining new studies or help with site management.
Enterprise Digital Transformation: The Geisinger Experience
In early 2020, Geisinger Health launched a multi-year digital transformation program to transform patient and caregiver experiences. The program sought to harness best-in-class technology solutions and innovation from the digital health ecosystem, and also envisioned the transformation of IT infrastructure to support digital health experiences. When the pandemic struck in early 2020, Geisinger’s leadership reaffirmed their commitment to the digital transformation road map and the strategic technology investments required to accelerate the transformation. To implement the road map, Geisinger established a Digital Transformation Office (DTO) to oversee the implementation of the road map, provide centralized governance, and enable technology partner selection for key aspects of the proposed road map. With broad cross-functional involvement and collaboration, the DTO was able to accelerate the transformation journey, improve digital engagement, and deliver millions of dollars in benefits.
Learning objectives
1) Identify best practices and learnings from how a large integrated health system is driving a multi-year digital transformation roadmap
2) Discover how technology is enabling digital transformation at the front and back end of healthcare operations and best practices in technology strategy and technology partner selection
3) Recognize how centralized governance can accelerate transformation and maximize value from technology investments
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Ultimately, the key to success in a dynamic market environment is data, both financial and clinical. Practices must be able to demonstrate their value empirically. Anesthesia practices have more and better data about what happens in the operating rooms and delivery suites than any other source in the facility. The most successful practices have learned to use this to demonstrate their value to the facility. ABC’s suite of technology products allow practices to easily integrate the data they have into tools designed to collect more, provide insight and aid in decision making.
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Main themes of the webinar included:
• Laying the appropriate groundwork in order to develop a world-class healthcare website
• How to use unified approaches to support scalable, multi-facility operations
• How to complete a large Web project while limiting timeline and budgeting risk
• Other helpful website tips, tricks and recommendations
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1. Selecting Electronic Data Capture Tools
2. Determining the EDC Budget
3. Usability and flexibility of the system
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Find out the best practices for implementing Electronic Data Capture systems in clinical trials http://bit.ly/2beFVmV
Customer Success Maturity Model
Customer success continues to be an emerging practice as both technology companies and nontraditional industries move to a new subscription revenue model. A maturity model framework helps companies establish their customer success organizations and initiatives, as well as allowing them to see where they stand and how they can improve as they move through the stages of maturity. www.tsia.com.
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DeactivatedKelie Hein 3 posts ReTopic 1 DQ 1Two GCU lib.docx
Deactivated
Kelie Hein
3 posts
Re:Topic 1 DQ 1
Two GCU library scholarly databases that will help me find the best research articles for my proposal are two databases that I appreciate, and currently use often: CINAHL Complete and PubMed. I like CINAHL Complete because it is quite specific to nursing. It also provides many full text articles free of charge, which is unfortunately not that common. Some databases provide only abstracts, and some require one to purchase the article (which can be 50 dollars!). I like PubMed because it has a wide array of health science articles that are peer-reviewed, but often have language that is easier to understand. PubMed is also quite user friendly.
These two databases are better than Google Scholar and/or a general internet search, for several reasons. While Google Scholar provides scholarly articles, it can sometimes be difficult to limit the search. Inexperienced users an easily become overwhelmed with the amount of data the search returns. A general internet search is not only daunting in terms of qualified research, but can be dangerous as well: Wikipedia sources, the evil of internet research, are often returned with general internet searches. Anyone can post on Wikipedia (and the internet in general). Scholarly databases are the safe way to go: safe for the researcher, and safe for the patients under the researcher’s
1
3
Strategies That Facilitate Influencing Power
AcelRx Pharmaceuticals Inc Company
STRATEGIES THAT FACILITATE INFLUENCING POWER
Acel Rx Pharmaceuticals Inc. has always provided quality service to its clients but the adoption of an online drugstore is a project that could make the services even better. However, various measures have to be put into place to facilitate the success of the project.
Strategies to Adapt Organizational Change
To adopt the online marketing and networking with customers then the Acel Rx Pharmaceuticals Inc. has to undergo some organizational change. Though the internet is the Internet could enable profound changes in the nature and structure of the healthcare industry and, ultimately, the delivery of healthcare services its adaptions should be strategic. First, there is need to carry out the change in phases with the start-up phase being clarifying the expectations and roles, assessing readiness, contracts and getting buy-in. In this phase is usually where the relationship between you (the initial change agent) and your client starts, whether you are an external or internal consultant. This means that Acel has to establish who its clients actually are, define the project conduct field research on the opinions of the customers after which they have to make the customers feel the problem at hand and the need to adopt this new technology which is aimed at making things better. It is important that the change agent should have good communication skills both verbal and non-verbal and a good listener.
Second in line is a jo.
Community health plan improves cost containment results by $11 million
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Planning Clinical Trial in USA.pdf
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
Real-World Evidence Studies_ Introduction, Purpose, and Data Collection Strat...
The first image that comes to mind when one thinks of where safety and
efficacy data for a new treatment is generated is a randomized controlled
trial (RCT) at a central site. Although RCTs remain the gold standard for
evidence generation of new treatments, they are limited in terms of their
applicability to broader patient populations with different demographics
such as age, ethnicity, and comorbidities thus limiting their
generalizability. RCTs are carried out under strict conditions and dosing
schedules which are often not observed in the real world and are
conducted for limited time periods which are usually not sufficient to
capture adverse events, especially in the case of chronic diseases. This
has led to a shift in the thinking of sponsors, drug developers, payers,
and regulators to consider the use of real-world data and
real-world-evidence studies to inform decisions related to the product as
well as to support reimbursement decisions.Real-world evidence (RWE) is the clinical evidence regarding the usage
and potential benefits or risks of a medicinal product obtained from
real-world data (RWD). RWD is regarded as observational data that is
collected outside of a traditional RCT (1). Although the terms RWD and
RWE are used interchangeably they are two distinct concepts. Not all
RWD translates into RWE. RWE is obtained by detailed analyses of data
from different types of trials such as pragmatic trials, observational
studies which can be prospective or retrospective, late-phase trials, or
hybrid trials which are designed to collect data from patients in a
real-world setting. The data that is collected can be in various forms such
as electronic health records (EHRS), claims and billing data, product and
disease registries, prescription data, data collected from routine hospital
and physician visits, patient-reported outcomes (PROs), and mobile and
wearable devices. Recently, data from biobanks and ‘-omics’ data is
becoming a valuable source of RWD. RWE studies are intended to
complement data generated from RCTs by providing a detailed view of
the actual use of the product and effectiveness and safety data that RCTs
are unable to capture.There has been a recent upward trend in the number of RWE trials
conducted. In 2021, the Global Data Clinical Trials Database recorded
194 RWE trials and the Food and Drug Administration (FDA) published
90 examples of the use of RWE to support regulatory decisions (2). Since
2018, the FDA has released several pieces of guidance to support the
use of RWD and RWE for regulatory decision-making for drugs and
medical devices and the type of data to be submitted to support these
applications. The two main drivers for recent interest and uptake of RWE
studies are:
IND Data Requirements and US FDA Submission.pdf
A clinical trial is a culmination of the several stages of a drug or medical
device development program that begins with the discovery of a
candidate molecule followed by preclinical toxicology studies in ex vivo, in
vitro, and animal models. Once the candidate molecule shows promising
results in these stages, the next step involves clinical studies on human
subjects. Drug testing in humans is often the most lengthy and expensive
phase of the drug development timeline, and therefore requires extensive
effort and careful execution to maximize the candidate’s chances of
success. In addition to scientific evaluation, clinical studies require
approval by the United States Food and Drug Administration (US FDA),
the regulatory authority in the United States to administer the
experimental drug in humans as well as ship it across state lines. This
approval comes in the form of an Investigational New Drug (IND FDA)
application that is required to be submitted by sponsors, investigators, or
research institutes to the FDA to commence studies on human
participants. The following figure shows the various stages of the drug
development program (Figure 1) marking IND submission on the timeline.
The US Food and Drug Administration (FDA) has established a comprehensive drug
development strategy for US FDA. This strategy is designed to ensure that the drugs
being developed meet the highest standards of safety and efficacy.The IND is a comprehensive document that contains all the information
gained from preclinical and other studies in an organized format. The
FDA reviews and makes the decision to support further clinical studies
from information in the IND that ultimately forms the basis of marketing
approval. INDs can be submitted at any phase during clinical
development to protect the safety and rights of subjects (Phase I) and to
assure adequate scientific evaluation of the drug’s effectiveness and
safety (Phase II and III). The Code of Federal Regulations CFR Title 21.
Part 312 Investigational New Drug Application contains information on
INDs as well as their content and format and should be reviewed
thoroughly by sponsors or investigators prior to submission of an IND
application.
The IND data requirements are important for the development of new drugs and
medical devices. They provide detailed information about the safety and efficacy of a
drug or device before it can be approved for use by the public
Cancer Clinical Trials_ USA Scenario and Study Designs.pdf
Clinical trials in oncology are vital for the advancement of cancer treatments and
care. The US is at the forefront of these clinical trials, with many different study
designs being used to assess the efficacy and safety of new treatments. This article
will explore the current state of oncology clinical trial services in the US, as well as
discuss different types of study designs that are commonly used. It will provide
insight into how these trials are conducted, what data is collected, and how this
information can be used to improve patient care.
The United States Food and Drug Administration (FDA) has released
several guidance documents over the years through the Oncology Center
of Excellence to support the development of oncologic treatments and
diagnoses. Furthermore, information on the clinical trials for the treatment
of different types of cancer or specific interventions can be found on the
National Cancer Institute (NCI) website and Clinical Trials. Currently,
ClinicalTrials.gov, a website maintained by the National Library of
Medicine (NLM) and the National Institutes of Health (NIH) contains
listings of publicly and privately sponsored trials and includes information
on 91,937 studies related to cancer indicating the high volume of
research being conducted in this field.According to the World Health Organization (WHO), cancer is the leading
cause of death worldwide, with a death rate of one in six in 2020 (1).
Aside from the high mortality rate and morbidity associated with cancer, it
also negatively impacts the quality of life and poses a significant financial
burden on patients and payers making it imperative to develop effective
treatments for the disease. According to Global Cancer Observatory
(GLOBACAN), the United States accounted for 13.3% of all estimated
new cases of cancer in 2020 (2). In 2020, the single leading type of
cancer in the United States was breast cancer (11.1%) followed by lung
cancer (10%), prostrate (9,2%), colorectum (6.8%), and melanoma of the
skin (4.2%). Despite the significant prevalence of cancer and numerous
clinical trials conducted for oncology treatments, data have shown an
almost 95% attrition rate for anticancer drugs from Phase I trials until
marketing authorization. Various factors such as inaccurate preclinical
models, lack of suitable biomarkers in clinical trials, and a disconnect
between industry, academia, and regulators are responsible for the high
attrition rate (3). Therefore, it is vital to develop suitable study designs
and protocols for candidate molecules such that they obtain regulatory
approval and can be marketed. In addition to these challenges, the
development of anti-cancer agents comes at a monumental cost of an
estimated $2.8 billion. Several factors such as the choice of relevant
endpoints, the choice of appropriate biomarkers that are guided by tumor
biology, and careful patient selection are expected to improve the overall
fate of oncologic agents in the clinical trial phase
Slider post_PR-07_14 Sep 1.pdf
Benefit-Risk Determination is defined as “the
analysis of all assessments of benefit and risk
of possible relevance for the use of the device
for the intended purpose, when used in
accordance with the intended purpose given
by the manufacturer
_Slider post_PR-05_30 August.pdf
The EU’s Medical Device Regulation (MDR) is a hot topic in
healthcare since it was officially published on 5th May 2017
and came into effect on 25 May 2017. The MDR replaces the
EU Medical Device Directive (93/42/EEC) and the Directive
on active implantable medical devices (90/385/EEC).
Slider post_PR MDR REF.-07_14 Sep.pdf
Risk is defined as “the combination of the probability
of occurrence of harm and the severity of that harm
Copy of Slider post_PR-06_07 Sep (1).pdf
The PMS process is focused on the collection and analysis of the data that comes from various sources and is carried out according to a PMS plan to be established for each MD in order to:
More from ProRelix Research (10)
Advancing Healthcare_ The Rise of Hybrid Virtual Clinical Trials.pdf
Advancing Healthcare_ The Rise of Hybrid Virtual Clinical Trials.pdf
Unlocking Opportunities in Online Clinical Research Courses.pdf
Unlocking Opportunities in Online Clinical Research Courses.pdf
Real-World Evidence Studies_ Introduction, Purpose, and Data Collection Strat...
Real-World Evidence Studies_ Introduction, Purpose, and Data Collection Strat...
Cancer Clinical Trials_ USA Scenario and Study Designs.pdf
Cancer Clinical Trials_ USA Scenario and Study Designs.pdf
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- 1. www.prorelixresearch.com How to Integrate eConsent in Trial Planning
- 2. This should be included in site-selection questionnaires, and checklists should be in place to help identify any challenges to eConsent adoption concerning experience, patient population, SOPs, technology, and connectivity. www.prorelixresearch.com Commitment to eConsent success begins at trial planning.
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