Clinical trials are essential for testing new medical treatments and ensuring their safety and efficacy. They involve dividing patients into groups that receive either an experimental treatment or the standard treatment in a controlled manner. The clinical trial process is carefully designed and regulated to obtain reliable results while protecting patients' rights and well-being. Large numbers of patients are needed to statistically prove whether a new treatment is better or worse than existing options. While new therapies may help future patients, there are no guarantees of success or improvement, so participation in clinical trials always involves some unknown risks.
This document summarizes an introduction to clinical trials presented by Jan B. Vermorken. It outlines the process of moving new cancer therapies from the laboratory to clinical trials, including preclinical testing requirements, phases of clinical trials (I-III), response criteria, and considerations for trials of non-cytotoxic agents. It also discusses the roles and functions of ethics committees in overseeing clinical trials to protect participants.
The document discusses key concepts in clinical trial designs, including types of trials, phases of trials, and protocol requirements according to ICH-GCP guidelines. It describes the various types of clinical trial designs such as treatment, prevention, diagnostic, and screening trials. It also outlines the different phases of clinical trials from phase I to phase IV and summarizes the key elements that must be included in a clinical trial protocol according to ICH-GCP, such as the trial design, randomization, blinding, treatment regimens and stopping rules.
Clinical trials are scientific studies that test new drugs in human subjects. This document discusses the multi-phase clinical trial process, from pre-clinical animal studies through post-approval monitoring. It notes that trials progress from small Phase I safety studies in healthy volunteers to large Phase III efficacy trials in patients. The goal is to demonstrate a drug's benefits outweigh its risks before regulatory approval and marketing.
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016wef
Clinical trials are research studies that test new medical treatments and are conducted according to a research plan called a protocol. A clinical trial has a principal investigator and research team who are responsible for overseeing the trial. Participants must meet eligibility criteria and provide informed consent to enroll. The trial follows a treatment plan, which may involve experimental treatments, standard treatments, or placebos. Participants are monitored by an Institutional Review Board to ensure safety and ethical treatment. Clinical trials provide information about new treatments and help advance medical knowledge, but may not directly benefit participants.
This document provides definitions for over 50 terms related to clinical trials. It begins with definitions for terms like adverse reaction, advocacy and support groups, approved drugs, arm (of a clinical trial), and baseline. It then continues to define important clinical trial concepts in alphabetical order, ending with definitions for randomized trial and quality of life trials.
This document discusses clinical trials, including their objectives, key aspects, and participating parties. The main points are:
Clinical trials examine and evaluate the safety and efficacy of therapies in human subjects. Their objectives include developing protocols, screening and enrolling participants, monitoring safety, and generating reports. Key elements are experimental units (subjects), treatments being tested, and ways of evaluating outcomes. Clinical trials involve various parties like sponsors, investigators and their teams, reviewing ethics boards, institutions hosting the trials, and regulatory authorities. They progress through defined pre-clinical and phases I-IV to develop therapies and ensure subjects' protection.
Clinical trial designs can be categorized in several ways:
1. Based on the method used to allocate participants such as randomized controlled trials, non-randomized controlled trials, parallel group designs, crossover designs, and withdrawal designs.
2. Based on awareness of participants and researchers, such as blinded, unblinded, and double-blinded trials.
3. Based on the magnitude of activity being tested, such as superiority, inferiority, equality, and dose-response relationships.
Common trial types include pilot studies, which test experimental design on a small scale, and placebo-controlled trials, which compare an intervention to a placebo. Randomized controlled trials are considered the gold standard for assigning participants randomly to treatment or
1) The document describes the phases of clinical trials, from Phase I to Phase III. Phase I trials involve small numbers of patients and evaluate safety, Phase II evaluates efficacy and identifies groups likely to benefit, and Phase III further evaluates efficacy and safety in large randomized controlled trials.
2) The document provides examples of Phase I, II, and III clinical trial designs and goals. Phase III trials are typically multicenter, randomized controlled trials used to generate evidence for marketing approval of new drugs. Control groups are important to account for factors like natural disease progression.
3) Clinical trials progress from exploratory Phase I safety studies to definitive Phase III trials evaluating efficacy versus a control as the standard for regulatory approval of new interventions.
This document summarizes an introduction to clinical trials presented by Jan B. Vermorken. It outlines the process of moving new cancer therapies from the laboratory to clinical trials, including preclinical testing requirements, phases of clinical trials (I-III), response criteria, and considerations for trials of non-cytotoxic agents. It also discusses the roles and functions of ethics committees in overseeing clinical trials to protect participants.
The document discusses key concepts in clinical trial designs, including types of trials, phases of trials, and protocol requirements according to ICH-GCP guidelines. It describes the various types of clinical trial designs such as treatment, prevention, diagnostic, and screening trials. It also outlines the different phases of clinical trials from phase I to phase IV and summarizes the key elements that must be included in a clinical trial protocol according to ICH-GCP, such as the trial design, randomization, blinding, treatment regimens and stopping rules.
Clinical trials are scientific studies that test new drugs in human subjects. This document discusses the multi-phase clinical trial process, from pre-clinical animal studies through post-approval monitoring. It notes that trials progress from small Phase I safety studies in healthy volunteers to large Phase III efficacy trials in patients. The goal is to demonstrate a drug's benefits outweigh its risks before regulatory approval and marketing.
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016wef
Clinical trials are research studies that test new medical treatments and are conducted according to a research plan called a protocol. A clinical trial has a principal investigator and research team who are responsible for overseeing the trial. Participants must meet eligibility criteria and provide informed consent to enroll. The trial follows a treatment plan, which may involve experimental treatments, standard treatments, or placebos. Participants are monitored by an Institutional Review Board to ensure safety and ethical treatment. Clinical trials provide information about new treatments and help advance medical knowledge, but may not directly benefit participants.
This document provides definitions for over 50 terms related to clinical trials. It begins with definitions for terms like adverse reaction, advocacy and support groups, approved drugs, arm (of a clinical trial), and baseline. It then continues to define important clinical trial concepts in alphabetical order, ending with definitions for randomized trial and quality of life trials.
This document discusses clinical trials, including their objectives, key aspects, and participating parties. The main points are:
Clinical trials examine and evaluate the safety and efficacy of therapies in human subjects. Their objectives include developing protocols, screening and enrolling participants, monitoring safety, and generating reports. Key elements are experimental units (subjects), treatments being tested, and ways of evaluating outcomes. Clinical trials involve various parties like sponsors, investigators and their teams, reviewing ethics boards, institutions hosting the trials, and regulatory authorities. They progress through defined pre-clinical and phases I-IV to develop therapies and ensure subjects' protection.
Clinical trial designs can be categorized in several ways:
1. Based on the method used to allocate participants such as randomized controlled trials, non-randomized controlled trials, parallel group designs, crossover designs, and withdrawal designs.
2. Based on awareness of participants and researchers, such as blinded, unblinded, and double-blinded trials.
3. Based on the magnitude of activity being tested, such as superiority, inferiority, equality, and dose-response relationships.
Common trial types include pilot studies, which test experimental design on a small scale, and placebo-controlled trials, which compare an intervention to a placebo. Randomized controlled trials are considered the gold standard for assigning participants randomly to treatment or
1) The document describes the phases of clinical trials, from Phase I to Phase III. Phase I trials involve small numbers of patients and evaluate safety, Phase II evaluates efficacy and identifies groups likely to benefit, and Phase III further evaluates efficacy and safety in large randomized controlled trials.
2) The document provides examples of Phase I, II, and III clinical trial designs and goals. Phase III trials are typically multicenter, randomized controlled trials used to generate evidence for marketing approval of new drugs. Control groups are important to account for factors like natural disease progression.
3) Clinical trials progress from exploratory Phase I safety studies to definitive Phase III trials evaluating efficacy versus a control as the standard for regulatory approval of new interventions.
This document outlines the key steps in conducting a clinical trial:
1. Drawing up a detailed research protocol that serves as the trial's operating manual.
2. Selecting and screening participants according to eligibility criteria to identify the study population. Sample size is also calculated.
3. Randomly allocating the study participants into experimental and control groups through a process like randomization to reduce bias.
Clinical trials are conducted to test new drugs, treatments or medical devices in humans to assess their safety and efficacy. There are four main phases of clinical trials:
Phase I trials involve small groups of people to determine basic safety and dosing requirements. Phase II trials expand the testing to more people to determine efficacy and further evaluate safety. Phase III trials involve large groups of people to confirm effectiveness, monitor side effects, compare to commonly used treatments and collect information to allow safe use of the intervention. Phase IV trials occur after the intervention has been marketed to gather information on effects in various populations and any long-term side effects.
1) Clinical trials involve prospectively assigning human participants to health interventions to evaluate effects on outcomes. They aim to carefully and ethically answer precisely framed questions.
2) Clinical trials are classified into phases based on goals, with Phase 0 trials involving small doses and numbers of participants to assess safety.
3) Randomization, blinding, inclusion/exclusion criteria, and sample size are important design considerations to reduce bias and ensure results reflect the interventions rather than other factors. Statistical analysis then determines if any effects seen are real or due to chance.
This document provides definitions for various clinical trial terms. It defines terms like adverse reaction, approval, arm, baseline, bias, blinding, case control study, clinical, clinical investigator, clinical research associate, and many others. For each term there is a brief 1-2 sentence definition explaining the meaning in the context of clinical research.
This document discusses various types of clinical trial designs. It begins by defining clinical trials and describing key elements like the PICO framework. It then covers ways to reduce bias through randomization and blinding. The document categorizes clinical trials based on factors like number of centers, control groups, randomization, and blinding. It provides details on traditional study designs like parallel group designs and crossover designs. It also discusses special designs for small populations and miscellaneous designs. Overall, the document provides an overview of different clinical trial designs, methods to reduce bias, and ways to categorize trial types.
This document discusses key considerations for clinical trial design, size, and study population. It outlines common trial designs like parallel group, crossover, and factorial designs. Appropriate study design and adequate sample size are important to achieve study objectives and answer key questions. Sample size calculations should account for the primary endpoint, expected treatment effect, variability, type I and II errors. Selection of subjects and controls also impacts trial validity. An independent data monitoring committee provides trial oversight.
The document provides an overview of the clinical trial process for new drugs. It discusses the various phases of clinical trials including preclinical testing in animals, Phase 0 microdosing studies, Phase I safety trials in healthy volunteers, Phase II small efficacy trials in patients, and Phase III large randomized controlled trials to confirm efficacy. The goal of clinical trials is to systematically evaluate a new drug's safety and efficacy in humans at various dose levels before it can be approved for marketing. Each phase addresses different objectives and increases in size and scope as the trials progress from preclinical to final approval stages.
Clinical trials and pharmacovigilance aim to ensure safety and efficacy of medical treatments. Various events highlighted the need for standards in clinical research involving human subjects. The International Conference on Harmonization developed the Good Clinical Practice guidelines addressing ethics, informed consent, data quality assurance and other principles. Clinical trials typically proceed through four phases to evaluate treatments, from initial small-scale testing in humans to larger confirmatory studies. Pharmacovigilance involves continually monitoring medicines for safety issues post marketing. Regulatory agencies provide oversight of clinical research and pharmacovigilance in India.
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
The Breast International Group (BIG) is the largest international network of academic breast cancer research groups. Facilitating international clinical trials is BIG's core expertise and for that reason, we have developed a slideshare presentation to explain the basics of clinical trials.
Some types of studies require unblinded personnel at the site and a matching unblinded monitoring and study management team. This presentation provides a little background on blinding and then reviews best practices for unblinding.
process of discovery of a new drug
what are clinical trials
why clinical trials are conducted
overview of phases in a clinical trial
details about every phase
focus and purpose of conducting clinical trial
This document outlines a clinical research protocol template. It begins with an introduction section defining clinical research and clinical trials. It then describes the purpose and contents of a clinical research protocol, including sections for objectives, background/rationale, study design, eligibility criteria, treatments, assessments, data collection and analysis, monitoring, ethics and regulations. The protocol template provides guidance on the level of detail needed for each section to clearly explain the research question, methodology, and procedures to ensure scientific validity and participant safety.
This document provides an overview of clinical trial design. It discusses the typical phases of clinical trials including:
- Phase I which focuses on safety and dose escalation
- Phase II which screens for therapeutic activity and further evaluates toxicity
- Phase III which uses a proper control group to further evaluate efficacy and monitors long-term safety
It also describes various study designs including randomized controlled trials, parallel designs, cross-over designs, and cohort studies. Key aspects of each design like advantages, disadvantages, and implementation are covered. The document provides a comprehensive yet concise primer on clinical trial methodology.
This document discusses the key features of clinical trials. It describes clinical trials as research studies that explore whether medical treatments are safe and effective for humans. The document outlines the various phases of clinical trials, from phase 1 to 4. Phase 1 trials focus on safety, while phase 2 assesses effectiveness and phase 3 involves large-scale trials. Phase 4 occurs after marketing approval to study long-term effects. Key parties involved in clinical trials are patients, investigators, sponsors and regulatory authorities. Clinical trials help develop new drugs and advance medical care, but must protect participant welfare and follow guidelines.
This document provides information about types of experimental studies and clinical trials. It discusses randomized controlled trials as the best way to test new treatments. The key steps in a RCT are described including developing a protocol, obtaining informed consent, randomization of participants, intervention, follow up, and assessment. Sources of bias in clinical trials and different trial designs such as parallel groups and cross-over designs are also summarized.
About Clinical Trials and Its Potential Benefits of ParticipatingVial Trials
Are you interested in clinical testing and want to learn about its phases and the potential benefits of participating? Then you must go through this blog right here!
The document provides an overview of clinical trials, including:
1) Clinical trials involve studying new drugs, procedures, or therapies on human subjects to test safety and efficacy.
2) Trials are organized into phases from 0 to IV, with Phase 0 involving microdosing and Phase I-III testing in larger groups.
3) Phase IV trials monitor safety after approval and can find rare side effects.
4) Trials must follow ethics guidelines to protect participants and receive oversight from institutional review boards.
Clinical trials involve several phases:
- Phase I trials involve small groups of healthy volunteers or patients and aim to determine the safety and tolerability of a new drug.
- Phase II trials involve larger groups of patients and aim to determine efficacy and further evaluate safety. These trials provide preliminary data on effectiveness.
- Phase III trials involve even more patients and aim to confirm effectiveness, monitor side effects, and compare the new treatment to standard treatment. These trials provide the primary data to support effectiveness. Regulatory approval is based on positive Phase III results showing safety and effectiveness.
This document outlines the key steps in conducting a clinical trial:
1. Drawing up a detailed research protocol that serves as the trial's operating manual.
2. Selecting and screening participants according to eligibility criteria to identify the study population. Sample size is also calculated.
3. Randomly allocating the study participants into experimental and control groups through a process like randomization to reduce bias.
Clinical trials are conducted to test new drugs, treatments or medical devices in humans to assess their safety and efficacy. There are four main phases of clinical trials:
Phase I trials involve small groups of people to determine basic safety and dosing requirements. Phase II trials expand the testing to more people to determine efficacy and further evaluate safety. Phase III trials involve large groups of people to confirm effectiveness, monitor side effects, compare to commonly used treatments and collect information to allow safe use of the intervention. Phase IV trials occur after the intervention has been marketed to gather information on effects in various populations and any long-term side effects.
1) Clinical trials involve prospectively assigning human participants to health interventions to evaluate effects on outcomes. They aim to carefully and ethically answer precisely framed questions.
2) Clinical trials are classified into phases based on goals, with Phase 0 trials involving small doses and numbers of participants to assess safety.
3) Randomization, blinding, inclusion/exclusion criteria, and sample size are important design considerations to reduce bias and ensure results reflect the interventions rather than other factors. Statistical analysis then determines if any effects seen are real or due to chance.
This document provides definitions for various clinical trial terms. It defines terms like adverse reaction, approval, arm, baseline, bias, blinding, case control study, clinical, clinical investigator, clinical research associate, and many others. For each term there is a brief 1-2 sentence definition explaining the meaning in the context of clinical research.
This document discusses various types of clinical trial designs. It begins by defining clinical trials and describing key elements like the PICO framework. It then covers ways to reduce bias through randomization and blinding. The document categorizes clinical trials based on factors like number of centers, control groups, randomization, and blinding. It provides details on traditional study designs like parallel group designs and crossover designs. It also discusses special designs for small populations and miscellaneous designs. Overall, the document provides an overview of different clinical trial designs, methods to reduce bias, and ways to categorize trial types.
This document discusses key considerations for clinical trial design, size, and study population. It outlines common trial designs like parallel group, crossover, and factorial designs. Appropriate study design and adequate sample size are important to achieve study objectives and answer key questions. Sample size calculations should account for the primary endpoint, expected treatment effect, variability, type I and II errors. Selection of subjects and controls also impacts trial validity. An independent data monitoring committee provides trial oversight.
The document provides an overview of the clinical trial process for new drugs. It discusses the various phases of clinical trials including preclinical testing in animals, Phase 0 microdosing studies, Phase I safety trials in healthy volunteers, Phase II small efficacy trials in patients, and Phase III large randomized controlled trials to confirm efficacy. The goal of clinical trials is to systematically evaluate a new drug's safety and efficacy in humans at various dose levels before it can be approved for marketing. Each phase addresses different objectives and increases in size and scope as the trials progress from preclinical to final approval stages.
Clinical trials and pharmacovigilance aim to ensure safety and efficacy of medical treatments. Various events highlighted the need for standards in clinical research involving human subjects. The International Conference on Harmonization developed the Good Clinical Practice guidelines addressing ethics, informed consent, data quality assurance and other principles. Clinical trials typically proceed through four phases to evaluate treatments, from initial small-scale testing in humans to larger confirmatory studies. Pharmacovigilance involves continually monitoring medicines for safety issues post marketing. Regulatory agencies provide oversight of clinical research and pharmacovigilance in India.
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
The Breast International Group (BIG) is the largest international network of academic breast cancer research groups. Facilitating international clinical trials is BIG's core expertise and for that reason, we have developed a slideshare presentation to explain the basics of clinical trials.
Some types of studies require unblinded personnel at the site and a matching unblinded monitoring and study management team. This presentation provides a little background on blinding and then reviews best practices for unblinding.
process of discovery of a new drug
what are clinical trials
why clinical trials are conducted
overview of phases in a clinical trial
details about every phase
focus and purpose of conducting clinical trial
This document outlines a clinical research protocol template. It begins with an introduction section defining clinical research and clinical trials. It then describes the purpose and contents of a clinical research protocol, including sections for objectives, background/rationale, study design, eligibility criteria, treatments, assessments, data collection and analysis, monitoring, ethics and regulations. The protocol template provides guidance on the level of detail needed for each section to clearly explain the research question, methodology, and procedures to ensure scientific validity and participant safety.
This document provides an overview of clinical trial design. It discusses the typical phases of clinical trials including:
- Phase I which focuses on safety and dose escalation
- Phase II which screens for therapeutic activity and further evaluates toxicity
- Phase III which uses a proper control group to further evaluate efficacy and monitors long-term safety
It also describes various study designs including randomized controlled trials, parallel designs, cross-over designs, and cohort studies. Key aspects of each design like advantages, disadvantages, and implementation are covered. The document provides a comprehensive yet concise primer on clinical trial methodology.
This document discusses the key features of clinical trials. It describes clinical trials as research studies that explore whether medical treatments are safe and effective for humans. The document outlines the various phases of clinical trials, from phase 1 to 4. Phase 1 trials focus on safety, while phase 2 assesses effectiveness and phase 3 involves large-scale trials. Phase 4 occurs after marketing approval to study long-term effects. Key parties involved in clinical trials are patients, investigators, sponsors and regulatory authorities. Clinical trials help develop new drugs and advance medical care, but must protect participant welfare and follow guidelines.
This document provides information about types of experimental studies and clinical trials. It discusses randomized controlled trials as the best way to test new treatments. The key steps in a RCT are described including developing a protocol, obtaining informed consent, randomization of participants, intervention, follow up, and assessment. Sources of bias in clinical trials and different trial designs such as parallel groups and cross-over designs are also summarized.
About Clinical Trials and Its Potential Benefits of ParticipatingVial Trials
Are you interested in clinical testing and want to learn about its phases and the potential benefits of participating? Then you must go through this blog right here!
The document provides an overview of clinical trials, including:
1) Clinical trials involve studying new drugs, procedures, or therapies on human subjects to test safety and efficacy.
2) Trials are organized into phases from 0 to IV, with Phase 0 involving microdosing and Phase I-III testing in larger groups.
3) Phase IV trials monitor safety after approval and can find rare side effects.
4) Trials must follow ethics guidelines to protect participants and receive oversight from institutional review boards.
Clinical trials involve several phases:
- Phase I trials involve small groups of healthy volunteers or patients and aim to determine the safety and tolerability of a new drug.
- Phase II trials involve larger groups of patients and aim to determine efficacy and further evaluate safety. These trials provide preliminary data on effectiveness.
- Phase III trials involve even more patients and aim to confirm effectiveness, monitor side effects, and compare the new treatment to standard treatment. These trials provide the primary data to support effectiveness. Regulatory approval is based on positive Phase III results showing safety and effectiveness.
Rappuoli slide scienza e industria 27:11:2013ridScienzainrete
This document discusses the potential for vaccines to serve global health and outlines Rino Rappuoli's talk on this topic. It notes that vaccines have allowed people to live longer and have been a paradigm of research in service of global health. New technologies over the last 30 years have made possible vaccines that were previously difficult or impossible. These include conjugate vaccines, reverse vaccinology, adjuvants, and synthetic biology.
This document discusses the phases of clinical trials. It begins by defining a clinical trial and explaining their importance. It then outlines the typical phases:
Phase I trials involve small groups of healthy volunteers and focus on safety, tolerability and pharmacokinetics. Phase II trials enroll larger numbers of patients to study efficacy and further evaluate safety. Phase III trials involve thousands of patients and aim to confirm efficacy and further monitor safety. Phase IV trials occur after marketing approval to further monitor long-term safety and efficacy.
The document provides details on the objectives, features, sample sizes, and information gained from each phase of trials. It discusses microdosing studies, pharmacogenomics studies, and post-marketing surveillance. In summary
This document discusses various clinical trial designs including parallel, crossover, factorial, and adaptive designs. It describes key elements of clinical trial methodology such as randomization, blinding, placebos, and controls. The document also outlines how clinical trial designs are applied differently in each phase of drug development from Phase 0 microdosing to Phase III confirmatory trials. Key challenges in clinical trial design like controlling bias and complex statistical analysis of factorial designs are also summarized.
The drug development process involves several phases of clinical trials overseen by regulatory agencies. Drugs must first show safety in pre-clinical animal and lab testing before entering human trials. Clinical trials involve 3 phases - Phase I tests safety in small groups, Phase II assesses efficacy and optimal dosing in larger groups of patients, and Phase III confirms efficacy in even larger groups. If results are positive, the drug company submits a New Drug Application to the regulatory agency which can take 2-3 years to review before approving the drug for the market. Post-market studies in Phase IV further monitor long-term safety and efficacy. The entire process from discovery to market approval takes an average of 10-15 years and over $1 billion
The document discusses the process of drug discovery, including target selection, lead discovery, medicinal chemistry, in vitro and in vivo studies, and clinical trials. Target selection involves identifying cellular or genetic targets involved in disease through techniques like genomics, proteomics, and bioinformatics. Lead discovery focuses on identifying small molecule modulators of protein function through methods like synthesis, combinatorial chemistry, assay development, and high-throughput screening. Medicinal chemistry then works to optimize these leads. [/SUMMARY]
Worldwide comprehensive study of guideline on clinical trialRGPV BHOPAL
The document provides information on various aspects of clinical trials including:
- The different phases of clinical trials from Phase 0 to Phase V
- Key elements of a clinical trial protocol such as objectives, design, and methodology
- Regulatory requirements for conducting clinical trials including compliance with ICH GCP guidelines
- Common recruitment strategies and important documents required for clinical trial authorization applications such as the clinical trial protocol, investigator brochure, and informed consent forms.
Audio and slides for this presentation are available on YouTube: http://youtu.be/NzJ_fvSxwGk
Sara Tolaney, MD, MPH, a breast oncologist with the Susan F. Smith Center for Women's Cancers at Dana-Farber Cancer Institute, gives an overview of phase I clinical trials and some of the new drugs being tested to treat breast cancer. This talk was originally given at the Metastatic Breast Cancer Forum at Dana-Farber on Oct. 5, 2013.
This document discusses pharmacokinetics, which is the quantitative study of how the body affects drugs. It covers key pharmacokinetic processes like absorption, distribution, metabolism and excretion. Absorption depends on factors like drug properties, route of administration and physiological factors. Distribution is the movement of drugs from blood to tissues. The extent of distribution is determined by properties like lipid solubility and protein binding.
The document summarizes Schedule Y of the Drugs and Cosmetics Act, which covers requirements for permission to import or manufacture new drugs in India and conduct clinical trials. It discusses rules for applications, responsibilities of sponsors, investigators and ethics committees. It also outlines the regulatory authorities involved and fees for applications. Requirements include preclinical and clinical data to be submitted along with applications for marketing approval or conducting trials.
This document provides definitions for key terms related to clinical trials and good clinical practice. It defines 58 terms, including adverse event, protocol, investigator, informed consent, monitoring, quality assurance and quality control. The definitions aim to clarify the proper conduct of clinical research and protection of trial subjects, according to international ethical and regulatory standards.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
This document discusses how PROC SQL can be useful for traditional SAS programming. It offers several advantages over procedural code, including easily accessing and combining data from multiple datasets, performing Cartesian products, fuzzy matching, and summarization. The document provides examples of using PROC SQL to solve problems involving these tasks more easily than procedural code. It also discusses how PROC SQL and macros can interact powerfully to solve complex programming problems.
This document provides guidance on interviewing basics, including the purpose of an interview, how to prepare, what to expect during the interview process, common question types, and follow-up steps. The main points covered are that the purpose of an interview is to receive a job offer, research the company and position thoroughly, prepare answers to common questions using the STAR technique, expect a variety of question types including behavioral and case questions, follow up with a thank you note within 48 hours.
This document is a problem report submitted by Harini Vaidyanath to West Virginia University in partial fulfillment of the requirements for a Master of Science degree in Statistics. The 38-page report discusses approximating probability density functions for aggregate claims in collective risk models. It covers risk theory concepts, methods for obtaining aggregate claims distributions like moment generating functions and direct convolutions, and using recursive techniques like the Panjer recursion formula to compute probability functions for different classes of claim distributions. Examples and R code are provided. The goal is to recursively compute probability functions and compare to normal and translated gamma approximations.
Controlled clinical trials are the best way to test new treatments and assess their efficacy and safety compared to existing treatments or no treatment. Clinical trials follow strict protocols to assign patients randomly to treatment groups, protect patient safety, obtain informed consent, and keep participant identities confidential. Registers of clinical trials are available online to help patients find trials that may suit their medical needs and preferences.
Controlled clinical trials are important for testing new treatments and improving existing ones. They allow treatments to be examined in a safe and efficient manner on large numbers of patients. New treatments must be evaluated through clinical trials to properly assess their efficacy and safety before being made available to patients. Controlled clinical trials help researchers learn about both the positive and negative effects of treatments.
This document discusses navigating patients to clinical trials. It defines what clinical trials are, which include testing new interventions to treat disease, assessing safety of new drugs, and evaluating quality of life. It outlines the different types and phases of clinical trials. It then specifically discusses the clinical trials available at Florida Hospital Cancer Institute, the benefits of participating in clinical trials, and how to navigate patients to clinical trials by being an advocate, calling the research department, and overcoming barriers like lack of awareness or access issues.
This document provides information about clinical trials and options for breast cancer patients. It discusses how clinical trials work, including the different phases of trials and protections for participants. Key points covered include how trials are regulated to protect participants, the voluntary nature of participation, and factors to consider when deciding whether to enroll in a trial such as potential benefits and drawbacks. Resources for finding current breast cancer trials are also mentioned.
Exploring Clinical Trials: How Research Can Help Us Better Detect, Diagnose, ...Ruchi Vahi
The exploration of clinical trials has become increasingly important in the medical field, with each trial providing insight into how we can better detect, diagnose and treat diseases. In this article, we will be looking at the different aspects of clinical research and trial processes, as well as discussing the importance of these studies in advancing healthcare treatments.
Visit us: https://mprex.in/project/late-phase-clinical-trials-and-research/
This document discusses common interview questions and answers related to clinical trial management jobs. It begins by defining key terms like clinical trials and their various types. It then addresses questions about participant eligibility, the trial process, informed consent, safety monitoring, and data management. Specific topics covered include trial phases, the purpose of placebos and control groups, adverse event reporting, and the responsibilities of clinical research coordinators.
SHARE Presentation: Maximizing Treatment Options -- What to Know When Conside...bkling
Current and former clinical trial participants discuss decision-making from a patient's perspective. What factors should you consider when choosing a clinical trial? What are the potential benefits of participating? What misconceptions might discourage people from seeking clinical trials? When is it best not to participate? Panelists include women living with metastatic breast and ovarian cancers.
Clinical trials are research studies that test whether medical treatments, procedures, devices, or lifestyle changes are safe and effective for humans. They can determine which approaches work best for certain conditions or groups of people. Without clinical trials, it would not be possible to develop new drugs or improve medical care. Clinical trials involve giving precise interventions to participants according to the study design and comparing outcomes. The results of clinical trials contribute significantly to medical knowledge and help improve future patient health by providing information on the benefits and risks of new and existing treatments. It is important for potential volunteers to research all aspects of a clinical trial, such as its purpose, procedures, risks, time commitment, and compensation, before agreeing to participate.
When you have a rare cancer like mesothelioma, it can be challenging to find treatment options as well as hope for your future. Clinical trials offer patients the opportunity to try the latest medications, surgical procedures or diagnostic screening tools which do provide realistic hope for longer, better quality of life. Many patients have questions about how to find clinical trials that they may be eligible for, understanding the different phases of a clinical trial and what to expect throughout the process. During our January session, we will discuss this and more!
Clinical trials are essential for testing the safety and efficacy of new drugs and medical devices. There are typically 4 phases of clinical trials for drugs, beginning with small safety trials and progressing to large efficacy trials. Medical device trials follow a similar progression but do not use placebos and must compare to existing standards of care. Clinical trials are expensive, with medical device trials costing on average $30,000-$40,000 per enrolled patient. Careful design and management can help minimize costs while still obtaining necessary data.
From History to Application Procedure OF CLINICAL TRIALS IN INDIA. PHASES 0,1,2,3,4 & 5.IMPORTANCE, advantages, guidelines global and India. Types, Design & blinding technique.
This document provides an overview of clinical research and clinical trials. It defines clinical research and clinical trials, discusses the importance of research. It describes the different types and phases of clinical trials, from phase 0 to phase IV. It outlines the key players involved in clinical trials and provides an overview of the clinical trial process from study design to statistical analysis and reporting.
Clinical trials are conducted to collect safety and efficacy data on health interventions such as drugs and devices. They begin with small pilot studies in healthy volunteers and/or patients, then expand to larger studies comparing the new intervention to standard treatments. Clinical trial design aims to limit bias through randomization, blinding, and placebos. Trials progress through phases from initial safety testing to confirmation of effectiveness in large populations. Systematic reviews then synthesize evidence from multiple high-quality randomized controlled trials.
Seriously Ill Patients Access To Experimental TherapiesRyan Witt
There are four main methods for terminally or seriously ill patients to access experimental therapies: clinical trials, expanded access programs, compassionate use protocols, and emergency use. However, few patients enroll in clinical trials or access experimental therapies through other means due to various barriers. These barriers include lack of awareness about opportunities, concerns from drug companies about liability and bad publicity, limitations on access to early-stage experimental therapies, and lack of incentives for drug companies to provide access. Efforts are needed to help more patients learn about and navigate options to access potentially life-saving experimental treatments.
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
Anyone intererested in participating in a clinical study should feel comfortable about the study and know as much as possible regarding participation in clinical research.
Adithyaelearning provides SAS CDM Online Training to the candidates having knowledge in the SAS. Throughout this course the participants will become qualified on the Clinical programming models as well as their usage in field of clinical research. The center areas for the course incorporate data integration, data manipulation, data listings production, figures and tables as per Statistical Examination Plan, as well as generation of reports and graphs. Besides this participants can be trained based on fundamental principles as well as concepts in the statistical methodology as well as clinical trials.
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Cosa conosciamo dell'interno del nostro Pianeta? L'accesso diretto alle viscere della Terra si limita a soli 11 km, lo 0.17% dei 6370 km del raggio terrestre.
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Scientific research in China has grown significantly in recent decades due to support from the Chinese government. The government has invested billions in research programs and developing universities as hubs for industry and academic collaboration. This has led to achievements like China sequencing the rice genome in 2002 at the Beijing Genomic Institute. The team of over 100 scientists published the draft genome sequence in Science, establishing China as a leader in genomic sequencing. Additionally, China is conducting extensive research on genetically modified plants for applications like increasing nutrition, crop hardiness, and producing vaccines and industrial chemicals. One breakthrough was the development of "Golden Rice" engineered to produce beta-carotene by researchers in Switzerland and China.
Giuseppe Brillante, giornalista e fotoreporter, e Stefano Brambilla, giornalista, autori del libro Birdwatching In Europa (Muzzio), illustrano alcune delle mete irrinunciabili dove osservare gli uccelli nel vecchio continente. Capiremo i trucchi per diventare birdwatcher provetti, senza dimenticare il galateo e il rispetto per l’ambiente.
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Il consumo energetico è la questione del futuro. Dipendiamo sempre più da fonti di energia che scarseggiano. D'altro canto il consumo di energia ha influenze drammatiche sui cambiamenti climatici. E' necessario affrontare la questione della riduzione dei consumi, soprattuto nel settore delle comunicazioni. Qui presentati e analizzati i consumi della telefonia mobile e del network.
Ospiti discreti nei parchi italiani - Laura FlorisScienzainrete
In occasione degli incontri "In viaggio con la natura" promossi da "Il Centro Studi Faunistica dei Vertebrati" della "Societa` Italiana di Scienze Naturali" Laura Floris, giornalista e condirettore della Rivista della Natura (Edinat), descrive le caratteristiche della Rivista della Natura e delle Guide alle aree protette italiane (Edinat).
- TP53 somatic mutations are frequent in many types of human cancer, occurring in approximately 50% of cancers.
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International Workshop of Bioethics on “Brain Death and Organ Donation: Ethical and Scientific Issues”, di G. Boniolo, H.R. Doyle, B. Fantini, J. Harris, I.R. Marino,
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The document discusses the relationship between universities and industry in the United States. It notes that federal research support is shifting to more industrial and private support. This represents a sea change in research funding models. The document advocates for organizing university research around "grand challenges" and "use-inspired basic research," with energy and health cited as examples. It also discusses models of collaborative research between universities, government and industry.
Cover Story - China's Investment Leader - Dr. Alyce SUmsthrill
In World Expo 2010 Shanghai – the most visited Expo in the World History
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China’s official organizer of the Expo, CCPIT (China Council for the Promotion of International Trade https://en.ccpit.org/) has chosen Dr. Alyce Su as the Cover Person with Cover Story, in the Expo’s official magazine distributed throughout the Expo, showcasing China’s New Generation of Leaders to the World.
Ellen Burstyn: From Detroit Dreamer to Hollywood Legend | CIO Women MagazineCIOWomenMagazine
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Navigating the world of forex trading can be challenging, especially for beginners. To help you make an informed decision, we have comprehensively compared the best forex brokers in India for 2024. This article, reviewed by Top Forex Brokers Review, will cover featured award winners, the best forex brokers, featured offers, the best copy trading platforms, the best forex brokers for beginners, the best MetaTrader brokers, and recently updated reviews. We will focus on FP Markets, Black Bull, EightCap, IC Markets, and Octa.
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NIMA2024 | De toegevoegde waarde van DEI en ESG in campagnes | Nathalie Lam |...BBPMedia1
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In a world where the potential of youth innovation remains vastly untouched, there emerges a guiding light in the form of Norm Goldstein, the Founder and CEO of EduNetwork Partners. His dedication to this cause has earned him recognition as a Congressional Leadership Award recipient.
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On episode 272 of the Digital and Social Media Sports Podcast, Neil chatted with Brian Fitzsimmons, Director of Licensing and Business Development for Barstool Sports.
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Industrial Tech SW: Category Renewal and CreationChristian Dahlen
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Dive into this presentation and learn about the ways in which you can buy an engagement ring. This guide will help you choose the perfect engagement rings for women.
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Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
2. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Introduction
Clinical Trials are the best way to test
whether a treatment is effective and
better than other treatments (or no
treatment).
New treatments or drugs for
diseases‘ prevention, early diagnosis
or cure are examined in a safe and
efficient way.
3. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Introduction
Clinical studies are the fastest
and safest way to find innovative
therapies and new effective
treatments.
4. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Introduction
As a patient, you might be
considering enrolling in a clinical
trial or you might be offered to by
your physician.
If you are interested in the
development of innovative
treatments, you can also be
proactive and increase your
knowuledge about clinical trials
by yourself.
5. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Introduction
This tutorial will teach you the
most important facts about
clinical trials.
Finally we hope to answer any
questions you might have
about this topic.
7. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical research aims to improve
existing therapies or to replace
them with new and better ones.
Before a new treatment is made
available for patients, it must be
tested in a clinical trial for safety
and efficacy.
8. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials are designed for
learning more about the
positive and negative effects
of a treatment.
Treatment‘s efficacy and
safety, however, can be totally
assessed only by long-term
use on patients in the daily
clinical practice.
9. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Before being tested on
patients in a clinical trial, new
treatments must be carefully
evaluted in the laboratory.
If labs results are promising, a
clinical trial can be designed
for studing efficacy and safety
of the new treatment.
10. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials are the only effective
and safe way to test a treatment
after it has been carefully
evalutated by laboratory analyses.
Clinical trials aim to assess not
only treatments‘ efficacy but also
all the possible risks.
11. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
New therapies need to be
statistically evaluated by clinical
trials on very large group of
similar patients (differences
among patients affected by the
same disease can quite big and
could affect the results of the
clinical trial).
Results must be systematically
reviewed and carefully
analysed.
12. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials conducted on large
number of patients are essential for
proving the safety and the efficacy
of a new therapy or drug.
True False
13. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials conducted on large
number of patients are essential for
proving the safety and the efficacy
of a new therapy or drug.
True False
Your choice is
correct!
14. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials conducted on large
number of patients are essential for
proving the safety and the efficacy
of a new therapy or drug.
True False
Your choice is
not correct!
15. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
New treatments that have
been tested in a laboratory
have no risks whatsoever
when used in clinical trials.
True False
16. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
If a new treatment has been
previously tested in laboratory
there is no risks whatsoever
when used in clinical trials.
True False
Correct! Laboratory tests help
designing new treatments but
cannot reveal risks for patients.
17. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
If a new treatment has been
previously tested in laboratory
there is no risks whatsoever
when used in clinical trials.
True False
Wrong!
New treatments can always
have unknown and
unpredictable risks.
19. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Why are Clinical Trials important?
Clinical trials help developing
new and better treatments for
patients.
Assessing safety and efficacy of
a new therapy is a very rigorous
and long process. For this
reason, new treatments usually
take a lot of time before
becoming available for the
public.
20. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Why are Clinical Trials important?
Clinical trials aim to enhance new
or already existing treatment
strategies or to check out new
therapeutic/diagnostic methods.
21. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Why are Clinical Trials important?
Clinical trials also important because
they investigate the causes of
diseases and their findings are
essential for enhancing the medical
progress.
23. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in Clinical Trials?
Patients enroll in clinical trials
for several reasons.
Many people hope to benefit
from having access to a new
treatment.
24. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
In order to avoid disappointment
you should remember that new
treatments are not automatically
better than standard ones in
terms of efficacy and safety (and
that‘s why a clinical trial is
needed!).
25. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Patients should be selected for a
clinical trial if they are likely to
benefit the the most from the new
treatment.
Clinical studies give them the
opportunity to get innovative and
experimental therapies not yet
available on the market.This is
especially true for diseases with no-
known cure.
26. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Some other participants wish to
contribute to medical research
and to help other patients by
voluntarily participating to a
clinical trial.
27. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Clinical trials‘ results always represent
an improvement of the standard
available treatment.
True False
28. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in Clinical Trial?
Clinical trials‘ results always represent
an improvement of the standard
available treatment.
True False
No!
Even if many clinical trials result in an
improvement of a therapy there is no
guarantee for success.
A new therapy could be as good as or
even worse the standard treatment.
29. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Clinical trials‘ results always represent
an improvement of the standard
available treatment.
True False
Yes!
Most but NOT all of the treatments
have turned out to be better than
the standard treatment.
30. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Researchers conducting a clinical trial
hope that their new treatment is better or
at least as good as the standard one
already available.
True False
31. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Researchers conducting a clinical trial
hope that their new treatment is better or
at least as good as the standard one
already available.
True False
Your choice is not correct.
Reseachers always conduct a
clinical trial to improve a
treatment or to find at least an
equally good one.
32. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Researchers conducting a clinical trial
hope that their new treatment is better or
at least as good as the standard one
already available.
True False
Correct!
Although disappointment is possible,
researchers always intend to achieve
an improved or at least an equally
good treatment.
34. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Every clinical trial is designed to
answer a series of scientific
questions about the tested
treatment.
The quality of a clinical trial and its
results heavily depends on a well
chosen clinical trial design.
35. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
When conducting a clinical trials,
researchers must always follow a
written study plan also called study
protocol.
The protocol both ensure patients‘
safety and is essential for achieving
high quality and reliable results.
36. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Some clinical trials are conducted
on one group of patients only, whilst
others compare two groups.
Patients of different groups must be
as much as possible similar e.g.
they must have the same medical
conditions and the same stadium of
the disease.
37. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Patients are assigned to one group or
another (therefore receiving the new
treatment or the standard one) by a
method called randomisation, i.e the
choice is made by chance through a
random generator.
38. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
When the study is conducted on two
group of patients, the first group is
called “controI group“ and often
receive the standard available
therapy, while the other one is called
“active group“ and is given the new
treatment.
This type of clinical trial is called
controlled trial.
39. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
The control group in a clinical trial is
treated with the same care as the
active.
If possible, neither the researchers nor
the patients should know which group
every participant has been assigned.
This special type of randomised trial is
called double-blind randomised trial
and ensure equal treatments for both
groups.
40. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
For many diseases there are no
standard treatment available yet. In
this case the control group receive
a dummy treatment called placebo
such as a sugar pill.
Important: For ethical reasons,
placebo control groups are not
allowed if a treatment already exists
and patients can benefit from it!
41. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Clinical trials firstly consider patients‘
safety and well being when testing a new
treatment.
True False
42. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Clinical trials firstly consider patients‘
safety and well being when testing a new
treatment.
True False
Correct!
43. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Clinical trials firstly consider patients‘
safety and well being when testing a new
treatment.
True False
Incorrect!
Clinical trials are firstly commited
to patients‘ safety and only in
second instance to scientific
results.
44. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
The control group always receives the
less effective treatment.
True False
45. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
The control group always receives the
less effective treatment.
True False
Incorrect!
Before the clinical trial is completed, it
is not possible to tell which treatment
will be better, whether the standard
therapy or the new treatment.
Both treatments could be equally
good for the patient.
46. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
The control group always receives the
less effective treatment.
True False
Correct!
When starting a clinical trail,
researchers cannot know yet whether
the standard therapy or the new
treatment will be better. Both
treatments could be equally good.
47. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
For ethical reasons, if during a clinical
trials clearly one treatment clearly
shows to be better than the other one,
the study is stopped and all the
participants are given the same
treatment.
48. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Patients should only enroll in a clinical
trial after having clearly understood
the benefits they could get and risks
they might incur in.
It is therefore essential that patients
are given clear and exhaustive
information before they agree to
partecipate.
50. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
The informed consent gives you all
the important information about any
aspects of the clinical trial before
deciding to enroll.
51. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
As a first step, every patient meets one
of the clinical trial researcher who will
explain in detail the possible benefits
but also risks in one-to-one talks.
52. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
After the meeting, the researcher will
hand you out the detailed information
about the trial in written form,
because you should carefully think
about a participation.
If you decides to enroll in, you must
return the informed consent signed
and personally dated.
Of course you always have the right
to refuse taking part in the trial.
53. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Informed consent ensures that nobody
enrolls in a clinical trial without having
received detailed information and having
personally given the consent to take part.
True False
54. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Informed consent ensures that nobody
enrolls in a clinical trial without having
received detailed information and having
personally given the consent to take part.
True False
Correct!
The informed consent protects
the patient‘s right for
information and ensures the
consent to the trial.
55. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Informed consent ensures that nobody
enrolls in a clinical trial without having
received detailed information and having
personally given the consent to take part.
True False
Incorrect!
The informed consent protects the
patient‘s right for information and
ensures the consent to the trial.
56. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
When you are partecipating to a
study, you will be countinuosly
updated with all the relevant
information about the trial which may
influence your decision to remain in
the trial.
The informed consent does not
obligate you to remain in the trial by
any means.
You can leave the clinical trial at any
time without giving any explanation!
57. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Once a participant has signed the
informed consent form, it is not possible
to leave the clinical trial anymore.
True False
58. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Once a participant has signed the
informed consent form, it is not possible
to leave the clinical trial anymore.
True False
Correct!
Participation is voluntary and
can be quit at any time.
59. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Once a participant has signed the
informed consent form, it is not possible
to leave the clinical trial anymore.
True False
Incorrect!
Despite a signed informed
consent, it is possible to quit a
clinical trial at any time.
60. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
You should ask any questions or
doubs you might have about the
clinical trial to the study team.
It is essential that you understand the
key statements in the informed
consent about the treatment, benefits
and risks.
62. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
Basic ethical principles and legal
codes which rule the medical
practice are also valid for clinical
trials!
In addition clinical trials are
governed through further
international guidelines and UK
legislations to protect participants
and to ensure their safety.
63. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
Every clinical trial is checked for
patients safety and scientific
contents by an ethics committee
and the competent authority before
it can start.
Every good study undergoes strict
quality controls by the competent
research body.
64. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
Results from progressing clinical
trials are published on scientific
conferences, in journals and
reported to the authorities.
The names of the participants are
subject to data privacy. It is not
allowed to publish names of study
participants.
65. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
It is standard that names of clinical trial
participants are kept secret.
True False
66. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
It is standard that names of clinical trial
participants are kept secret.
True False
Incorrect!
The names of study
participants cannot be
revealed for privacy reasons.
67. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
It is standard that names of clinical trial
participants are kept secret.
True False
Correct!
It is standard in clinical trials that
names of participants are subject
of data privacy.
68. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Where Can I Find Clinical
Trials?
-Trials Register –
change on the right!
69. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Trials Register
If you are looking for a particular clinical trial you can
directly ask your doctor.
In addition you can search the website of the
National Health Service for relevant trials
http://www.nhs.uk/Conditions/Clinical-
trials/Pages/clinical-trial.aspx/
or the website of the ISRCTN
http://www.controlled-trials.com/ukctr/
70. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Trials Register
Registers contain public information
about recruiting and running studies,
about the place, the aim of the
study, its design and the information
about patients‘ selection criteria.
The trials register should also
contain contact information for
patients interested in partecipating.
72. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Summary
A clinical trial is a research study
conducted in oreder to test new
treatments on patients.
Clinical trials have precise and well
defined aims whose details are
detscribed by the study plan (protocol).
73. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Summary
Clinical Trials are the fastest and
safest way to make new treatments,
which are better than the standard
ones, available to the public.
Clinical studies must be approved by
ethics committee and competent
authorities which review the study plan
and give their authorization.
74. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Summary
Participating to clinical trials is always
voluntary.
You can quit a clinical trial at any time
– despite having signed the informed
consent.
Your personal rights and data are
protected.
75. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Summary
We hope you liked this short tutorial and
found it useful. Keep exploring the
ECRAN website and learn even more
about clinical trials!
Thank you for your kind attention!