This document provides an overview of clinical trials, including their purpose, classifications, terminology, design, phases, ethics, and impact. It discusses how clinical trials test interventions to collect data and further understanding, outlines the main types of research studies, and describes key components of clinical trial protocols including recruitment, informed consent, and oversight. The summary emphasizes that clinical trials aim to better understand health while protecting participants, through review boards and ethical standards.
The document summarizes key ethical principles for conducting clinical trials including: obtaining informed consent, minimizing risks and ensuring a favorable risk-benefit ratio for participants, selecting participants equitably, respecting privacy and confidentiality, having trials approved and monitored by an IRB, stopping trials if risks are found to outweigh benefits, and disseminating results. It also discusses ethical issues around placebos, randomization, choice of controls, recruitment, monitoring safety, authorship, and conflicts of interest.
This document discusses the history and importance of research ethics. It describes several infamous human experiments that violated ethics standards, including the Tuskegee Syphilis Study and Nazi experiments. Milestones in developing ethics guidelines are reviewed, such as the Nuremberg Code, Belmont Report, Declaration of Helsinki, and ICMR guidelines in India. The document emphasizes enforcing standards to protect human subjects and gain informed consent in research.
Pharmacoepidemiology is the study of the use and effects of drugs in large populations. It combines clinical pharmacology and epidemiology to study drug use, benefits and risks. Pharmacoepidemiology uses observational studies, experimental studies, and quantitative synthesis to generate and test hypotheses about drug risks and benefits. Common study designs include cohort studies, case-control studies, randomized controlled trials, meta-analyses and decision analyses. Pharmacoepidemiology aims to optimize the benefit-risk balance of drugs.
- Cohort studies follow groups of individuals over time to determine the incidence of an outcome. Prospective cohort studies enroll participants before the outcome occurs, while retrospective cohort studies enroll participants who already have the outcome.
- Case-control studies compare cases who have an outcome to controls who do not, and look back to examine risk factor exposure between the groups. This design is useful for rare outcomes or those with long latency periods.
- Both study designs can estimate relative risks but cohort studies directly measure incidence, while case-control studies estimate odds ratios to examine relationships between risk factors and outcomes. Selection bias, information bias, and incomplete control of variables are challenges for both.
Observational analytical and interventional studiesAchyut Raj Pandey
This document provides an overview of different types of epidemiological study designs, including observational analytical studies like cohort and case-control studies, as well as experimental studies. It describes key aspects of cohort and case-control studies such as their designs, advantages, disadvantages, examples, and considerations for conducting them. Cohort studies follow groups over time from exposure to outcome, while case-control studies identify cases and controls and look back from outcome to exposure. Experimental studies actively alter variables to assess relationships between them.
This document discusses ethics in health research. It provides an overview of the origins and principles of ethics, including teleological and deontological perspectives. It then discusses ethics specifically in the context of health research, including how research must be useful and avoid harm. The document outlines several historical examples of unethical human experimentation, such as the Nazi experiments and Unit 731 tests during WWII. It also discusses international efforts to establish ethical guidelines, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The core ethical principles of autonomy, beneficence, justice, and respect for the environment are covered. Elements of informed consent and protections for vulnerable populations are also summarized.
This document discusses experimental studies and randomized clinical trials. It defines clinical trials as medical research studies conducted with human subjects to evaluate new interventions. Randomized clinical trials are described as the gold standard for comparing an intervention to a placebo or control group by randomly assigning subjects to each. The basic steps of a randomized clinical trial are outlined as drawing up a protocol, selecting study populations, randomizing subjects, administering the intervention, follow up, and assessment of outcomes. Advantages include providing evidence of causality, while disadvantages include cost and sample size requirements. Methods to reduce bias like randomization and blinding are also described.
The document summarizes key ethical principles for conducting clinical trials including: obtaining informed consent, minimizing risks and ensuring a favorable risk-benefit ratio for participants, selecting participants equitably, respecting privacy and confidentiality, having trials approved and monitored by an IRB, stopping trials if risks are found to outweigh benefits, and disseminating results. It also discusses ethical issues around placebos, randomization, choice of controls, recruitment, monitoring safety, authorship, and conflicts of interest.
This document discusses the history and importance of research ethics. It describes several infamous human experiments that violated ethics standards, including the Tuskegee Syphilis Study and Nazi experiments. Milestones in developing ethics guidelines are reviewed, such as the Nuremberg Code, Belmont Report, Declaration of Helsinki, and ICMR guidelines in India. The document emphasizes enforcing standards to protect human subjects and gain informed consent in research.
Pharmacoepidemiology is the study of the use and effects of drugs in large populations. It combines clinical pharmacology and epidemiology to study drug use, benefits and risks. Pharmacoepidemiology uses observational studies, experimental studies, and quantitative synthesis to generate and test hypotheses about drug risks and benefits. Common study designs include cohort studies, case-control studies, randomized controlled trials, meta-analyses and decision analyses. Pharmacoepidemiology aims to optimize the benefit-risk balance of drugs.
- Cohort studies follow groups of individuals over time to determine the incidence of an outcome. Prospective cohort studies enroll participants before the outcome occurs, while retrospective cohort studies enroll participants who already have the outcome.
- Case-control studies compare cases who have an outcome to controls who do not, and look back to examine risk factor exposure between the groups. This design is useful for rare outcomes or those with long latency periods.
- Both study designs can estimate relative risks but cohort studies directly measure incidence, while case-control studies estimate odds ratios to examine relationships between risk factors and outcomes. Selection bias, information bias, and incomplete control of variables are challenges for both.
Observational analytical and interventional studiesAchyut Raj Pandey
This document provides an overview of different types of epidemiological study designs, including observational analytical studies like cohort and case-control studies, as well as experimental studies. It describes key aspects of cohort and case-control studies such as their designs, advantages, disadvantages, examples, and considerations for conducting them. Cohort studies follow groups over time from exposure to outcome, while case-control studies identify cases and controls and look back from outcome to exposure. Experimental studies actively alter variables to assess relationships between them.
This document discusses ethics in health research. It provides an overview of the origins and principles of ethics, including teleological and deontological perspectives. It then discusses ethics specifically in the context of health research, including how research must be useful and avoid harm. The document outlines several historical examples of unethical human experimentation, such as the Nazi experiments and Unit 731 tests during WWII. It also discusses international efforts to establish ethical guidelines, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The core ethical principles of autonomy, beneficence, justice, and respect for the environment are covered. Elements of informed consent and protections for vulnerable populations are also summarized.
This document discusses experimental studies and randomized clinical trials. It defines clinical trials as medical research studies conducted with human subjects to evaluate new interventions. Randomized clinical trials are described as the gold standard for comparing an intervention to a placebo or control group by randomly assigning subjects to each. The basic steps of a randomized clinical trial are outlined as drawing up a protocol, selecting study populations, randomizing subjects, administering the intervention, follow up, and assessment of outcomes. Advantages include providing evidence of causality, while disadvantages include cost and sample size requirements. Methods to reduce bias like randomization and blinding are also described.
This document discusses the history and importance of clinical research. It notes that while medical research has only recently emerged as a formal discipline, epidemiological practices date back centuries to figures like Hippocrates, James Lind, Edward Jenner, John Snow, Ignaz Semmelweis, and Joseph Goldberger. Their studies helped establish strong methodologies in the 1940s-1950s. The document outlines reasons for conducting research, including fulfilling degree requirements, advancing medical knowledge as the field continues expanding, and contributing to the art and science of medicine. It argues doctors should be trained in research to apply findings wisely, produce research that helps colleagues, and consume research accurately to treat patients. Finally, it describes seven key reasons related to
This study aims to prevent childhood obesity through early childhood feeding and parenting guidance. It will randomize pregnant women into an intervention and control group. The intervention group will receive home visits and guidance from community health workers, while the control group will only receive measurements. The study hypothesizes that fewer children in the intervention group will be overweight or obese due to differences in feeding practices and responsiveness to infant cues. Data on infant growth, diet, sleep and more will be collected to assess the effectiveness of the early intervention program in preventing childhood obesity.
This document provides guidance on how to conduct clinical research at KEMU. It begins by defining key terms like clinical trials and observational studies. It then discusses James Lind's seminal clinical trial from the 18th century that demonstrated citrus fruits could treat scurvy in sailors. The document outlines the basic building blocks of a clinical study, including developing a research question, hypothesis, methods, observations, results, and conclusions. It provides details on study types, the importance of IRB approval, randomization, recruiting participants, collecting and analyzing data, and reporting outcomes and adverse events. Finally, it summarizes a clinical trial that compared the direct thrombin inhibitor dabigatran to warfarin for treating venous thromboemb
This document contains a series of exercises on study design for epidemiological research. It provides examples of different types of studies including cohort studies, case-control studies, cross-sectional studies, and longitudinal studies. For each proposed research question, it identifies the most appropriate study design and describes how that design could be implemented to study the relationship of interest. The document also tests understanding of key characteristics and methodologies for different epidemiological study designs.
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 discusses different types of epidemiological studies including descriptive studies, analytical studies, and experimental studies. Descriptive studies are divided into population studies and individual studies. Analytical studies include case-control studies and cohort studies. Key aspects of case-control and cohort study designs such as selection of cases/controls, sources of information, issues in analysis/interpretation, and strengths/weaknesses are described.
This document discusses key concepts in clinical research and scientific inquiry. It defines research as a systematic investigation designed to contribute to generalizable knowledge. The anatomy of a research project includes a research question, background and significance, study design, subjects, variables, and statistical issues. A good research question should be feasible, interesting, novel, ethical, and relevant. The physiology of research relates to internal and external validity and minimizing random and systematic errors.
Experimental epidemiology aims to provide scientific proof of disease causes and evaluate health interventions. Randomized controlled trials are the gold standard for testing hypotheses. Key elements of RCTs include being prospective, having an intervention and control group, and being randomized and blinded. RCTs involve developing a protocol, selecting and randomizing populations, implementing interventions, following up on outcomes, and assessing results by comparing intervention and control groups. Non-randomized trials may also be used when RCTs are not feasible.
Clinical trials progress through phases (preclinical, I-IV) to evaluate treatments safely in humans. Preclinical testing occurs in labs and animals. Phase I studies evaluate safety in 20-80 healthy volunteers. Phase II expands to 100-300 patient volunteers to assess efficacy. Phase III further tests efficacy in 1,000-3,000 patients. FDA approval requires compliance with Good Clinical Practice guidelines to protect subject rights and ensure credible data. Key elements include oversight by independent review boards, informed consent, qualified investigators and sponsors, adherence to protocols, and comprehensive record keeping.
Jasmine should not have begun data collection without IRB approval. She will need to discard any data collected prior to receiving approval and restart the study only after obtaining approval. Researchers cannot apply for retrospective approval or use data collected without approval.
Guidelines for the preparation of protocol and documents in clnical trialsSachin Kumar
The document discusses documentation requirements for clinical studies, including Good Clinical Practice (GCP) guidelines and federal regulations. It provides examples of essential documents that must be maintained at different stages of a study, such as documents created before, during, and after a study. It also discusses source documents, progress notes, documentation of investigational drugs, and other sponsor-required documents like quality assurance and training records. Proper documentation is necessary to obtain useful study data and demonstrate compliance with regulations.
This document provides an introduction to medical research. It defines different types of research including primary and secondary research. It describes various research study designs such as in vitro studies, animal studies, case reports, observational studies including cross-sectional, case-control and cohort studies, as well as clinical trials. It also discusses different types of literature reviews including traditional reviews, systematic reviews and meta-analyses. Key differences between these review types include the use of checklists, inclusion/exclusion criteria, and quality assessments. The document concludes by outlining the typical sections of a research paper and listing some common medical databases.
Clinical trial protocol: strategy for successidkpharma
The document outlines the key elements of a successful clinical trial protocol. A protocol is a document that provides guidelines for a clinical trial, including its objectives, design, methodology, and organization. It aims to obtain appropriate data on a drug's clinical properties within the shortest timeline and at minimal cost, while ensuring patient safety and adherence to regulatory standards. The document discusses 10 essential elements for an effective protocol: medical expertise, prior experience, hypothesis, endpoints, safety measures, credibility, rationality, structure, simplicity, and legitimacy. It emphasizes the importance of a protocol in providing clear guidelines to ensure a clinical trial's objectives are achieved efficiently and ethically.
This document provides guidelines for evaluating patients with pulmonary nodules from the American College of Chest Physicians. It summarizes the guideline objectives, target population, diagnostic and management interventions considered, major outcomes, methodology, recommendations, and validation process. The guideline was developed through a systematic review of literature and expert consensus to provide evidence-based recommendations. It defines solitary pulmonary nodules and provides 12 major recommendations on pre-test probability assessment, imaging tests, PET scanning, discussion of risks/benefits with patients, and tissue diagnosis.
The document discusses various ethical considerations in clinical trials, including planning trials, conducting research ethically, analyzing and reporting results, and ensuring justice. It provides an overview of guidelines for ethical clinical practice and considers issues like informed consent, minimizing risks and benefits, and equitable participant selection. Ensuring ethical research requires following principles like transparency, minimizing harm, and respecting participants' autonomy and welfare.
History ethical guide lines to clinical trialAnju Thejkumar
The document summarizes the history of ethical guidelines for clinical trials. It discusses several key documents and events that shaped modern research ethics, including the Nuremberg Code established after World War 2 Nazi experiments, the Declaration of Helsinki, Belmont Report, ICH GCP guidelines, and India's Ethical Guidelines for Biomedical Research in Human Subjects. Overall it provides an overview of the evolution of clinical trial ethics from the 1940s to 2000 to protect human subjects and ensure scientific integrity.
Institutional review board by akshdeep sharmaAkshdeep Sharma
The Institutional Review Board/Independent Ethics Committee (IRB/IEC) serves as an independent body that reviews and approves clinical trials to protect participant safety and rights. The IRB/IEC consists of at least five members with diverse qualifications to evaluate scientific and ethical aspects of trials. The IRB/IEC's responsibilities include reviewing trials, providing continuing oversight, ensuring informed consent, and maintaining records for regulatory review.
Clinical Science for Medical Devices: A Guide for Entrepreneurs | Jim Gustafs...UCICove
This document provides an overview of clinical science for medical devices aimed at entrepreneurs. It discusses the importance of clinical studies to prove a device is safe, effective, and provides value. Key elements that are always part of clinical trial design are the patients in the study, the treatment being evaluated, and the outcomes being measured. The presenter emphasizes minimizing bias in studies and having an a priori analysis plan. Other topics covered include informed consent, oversight boards, executing studies properly, interpreting results, and lessons from experience. The goal is to help entrepreneurs appreciate the value and complexities of clinical research.
Drug Discovery, Development & Clinical trials: Current status and the way...JEETU GANGIL
India has become a top destination for clinical drug trials due to its large patient population, lower costs compared to Western countries, and adherence to international standards. The Indian pharmaceutical market is expected to triple in size to $20 billion by 2015, making it one of the top 10 markets globally. However, India faces some challenges like increasing its regulatory reputation and infrastructure to fully capitalize on the growing clinical research industry.
Lec 4 nutrition therapy that apply to specific situationsSiham Gritly
This document provides dietary advice and nutrition therapy for managing diabetes and related complications. It discusses recommendations for heart health, hypertension, dyslipidemia, pregnancy, the elderly, ethnic groups, and eating disorders. Specific advice is given for limiting saturated fats, sodium, added sugars and refined grains while emphasizing fruits, vegetables, whole grains, nuts seeds and plant-based oils. Tight glycemic control and medical nutrition therapy are important for improving health outcomes and reducing risks of diabetes complications.
This document discusses the history and importance of clinical research. It notes that while medical research has only recently emerged as a formal discipline, epidemiological practices date back centuries to figures like Hippocrates, James Lind, Edward Jenner, John Snow, Ignaz Semmelweis, and Joseph Goldberger. Their studies helped establish strong methodologies in the 1940s-1950s. The document outlines reasons for conducting research, including fulfilling degree requirements, advancing medical knowledge as the field continues expanding, and contributing to the art and science of medicine. It argues doctors should be trained in research to apply findings wisely, produce research that helps colleagues, and consume research accurately to treat patients. Finally, it describes seven key reasons related to
This study aims to prevent childhood obesity through early childhood feeding and parenting guidance. It will randomize pregnant women into an intervention and control group. The intervention group will receive home visits and guidance from community health workers, while the control group will only receive measurements. The study hypothesizes that fewer children in the intervention group will be overweight or obese due to differences in feeding practices and responsiveness to infant cues. Data on infant growth, diet, sleep and more will be collected to assess the effectiveness of the early intervention program in preventing childhood obesity.
This document provides guidance on how to conduct clinical research at KEMU. It begins by defining key terms like clinical trials and observational studies. It then discusses James Lind's seminal clinical trial from the 18th century that demonstrated citrus fruits could treat scurvy in sailors. The document outlines the basic building blocks of a clinical study, including developing a research question, hypothesis, methods, observations, results, and conclusions. It provides details on study types, the importance of IRB approval, randomization, recruiting participants, collecting and analyzing data, and reporting outcomes and adverse events. Finally, it summarizes a clinical trial that compared the direct thrombin inhibitor dabigatran to warfarin for treating venous thromboemb
This document contains a series of exercises on study design for epidemiological research. It provides examples of different types of studies including cohort studies, case-control studies, cross-sectional studies, and longitudinal studies. For each proposed research question, it identifies the most appropriate study design and describes how that design could be implemented to study the relationship of interest. The document also tests understanding of key characteristics and methodologies for different epidemiological study designs.
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 discusses different types of epidemiological studies including descriptive studies, analytical studies, and experimental studies. Descriptive studies are divided into population studies and individual studies. Analytical studies include case-control studies and cohort studies. Key aspects of case-control and cohort study designs such as selection of cases/controls, sources of information, issues in analysis/interpretation, and strengths/weaknesses are described.
This document discusses key concepts in clinical research and scientific inquiry. It defines research as a systematic investigation designed to contribute to generalizable knowledge. The anatomy of a research project includes a research question, background and significance, study design, subjects, variables, and statistical issues. A good research question should be feasible, interesting, novel, ethical, and relevant. The physiology of research relates to internal and external validity and minimizing random and systematic errors.
Experimental epidemiology aims to provide scientific proof of disease causes and evaluate health interventions. Randomized controlled trials are the gold standard for testing hypotheses. Key elements of RCTs include being prospective, having an intervention and control group, and being randomized and blinded. RCTs involve developing a protocol, selecting and randomizing populations, implementing interventions, following up on outcomes, and assessing results by comparing intervention and control groups. Non-randomized trials may also be used when RCTs are not feasible.
Clinical trials progress through phases (preclinical, I-IV) to evaluate treatments safely in humans. Preclinical testing occurs in labs and animals. Phase I studies evaluate safety in 20-80 healthy volunteers. Phase II expands to 100-300 patient volunteers to assess efficacy. Phase III further tests efficacy in 1,000-3,000 patients. FDA approval requires compliance with Good Clinical Practice guidelines to protect subject rights and ensure credible data. Key elements include oversight by independent review boards, informed consent, qualified investigators and sponsors, adherence to protocols, and comprehensive record keeping.
Jasmine should not have begun data collection without IRB approval. She will need to discard any data collected prior to receiving approval and restart the study only after obtaining approval. Researchers cannot apply for retrospective approval or use data collected without approval.
Guidelines for the preparation of protocol and documents in clnical trialsSachin Kumar
The document discusses documentation requirements for clinical studies, including Good Clinical Practice (GCP) guidelines and federal regulations. It provides examples of essential documents that must be maintained at different stages of a study, such as documents created before, during, and after a study. It also discusses source documents, progress notes, documentation of investigational drugs, and other sponsor-required documents like quality assurance and training records. Proper documentation is necessary to obtain useful study data and demonstrate compliance with regulations.
This document provides an introduction to medical research. It defines different types of research including primary and secondary research. It describes various research study designs such as in vitro studies, animal studies, case reports, observational studies including cross-sectional, case-control and cohort studies, as well as clinical trials. It also discusses different types of literature reviews including traditional reviews, systematic reviews and meta-analyses. Key differences between these review types include the use of checklists, inclusion/exclusion criteria, and quality assessments. The document concludes by outlining the typical sections of a research paper and listing some common medical databases.
Clinical trial protocol: strategy for successidkpharma
The document outlines the key elements of a successful clinical trial protocol. A protocol is a document that provides guidelines for a clinical trial, including its objectives, design, methodology, and organization. It aims to obtain appropriate data on a drug's clinical properties within the shortest timeline and at minimal cost, while ensuring patient safety and adherence to regulatory standards. The document discusses 10 essential elements for an effective protocol: medical expertise, prior experience, hypothesis, endpoints, safety measures, credibility, rationality, structure, simplicity, and legitimacy. It emphasizes the importance of a protocol in providing clear guidelines to ensure a clinical trial's objectives are achieved efficiently and ethically.
This document provides guidelines for evaluating patients with pulmonary nodules from the American College of Chest Physicians. It summarizes the guideline objectives, target population, diagnostic and management interventions considered, major outcomes, methodology, recommendations, and validation process. The guideline was developed through a systematic review of literature and expert consensus to provide evidence-based recommendations. It defines solitary pulmonary nodules and provides 12 major recommendations on pre-test probability assessment, imaging tests, PET scanning, discussion of risks/benefits with patients, and tissue diagnosis.
The document discusses various ethical considerations in clinical trials, including planning trials, conducting research ethically, analyzing and reporting results, and ensuring justice. It provides an overview of guidelines for ethical clinical practice and considers issues like informed consent, minimizing risks and benefits, and equitable participant selection. Ensuring ethical research requires following principles like transparency, minimizing harm, and respecting participants' autonomy and welfare.
History ethical guide lines to clinical trialAnju Thejkumar
The document summarizes the history of ethical guidelines for clinical trials. It discusses several key documents and events that shaped modern research ethics, including the Nuremberg Code established after World War 2 Nazi experiments, the Declaration of Helsinki, Belmont Report, ICH GCP guidelines, and India's Ethical Guidelines for Biomedical Research in Human Subjects. Overall it provides an overview of the evolution of clinical trial ethics from the 1940s to 2000 to protect human subjects and ensure scientific integrity.
Institutional review board by akshdeep sharmaAkshdeep Sharma
The Institutional Review Board/Independent Ethics Committee (IRB/IEC) serves as an independent body that reviews and approves clinical trials to protect participant safety and rights. The IRB/IEC consists of at least five members with diverse qualifications to evaluate scientific and ethical aspects of trials. The IRB/IEC's responsibilities include reviewing trials, providing continuing oversight, ensuring informed consent, and maintaining records for regulatory review.
Clinical Science for Medical Devices: A Guide for Entrepreneurs | Jim Gustafs...UCICove
This document provides an overview of clinical science for medical devices aimed at entrepreneurs. It discusses the importance of clinical studies to prove a device is safe, effective, and provides value. Key elements that are always part of clinical trial design are the patients in the study, the treatment being evaluated, and the outcomes being measured. The presenter emphasizes minimizing bias in studies and having an a priori analysis plan. Other topics covered include informed consent, oversight boards, executing studies properly, interpreting results, and lessons from experience. The goal is to help entrepreneurs appreciate the value and complexities of clinical research.
Drug Discovery, Development & Clinical trials: Current status and the way...JEETU GANGIL
India has become a top destination for clinical drug trials due to its large patient population, lower costs compared to Western countries, and adherence to international standards. The Indian pharmaceutical market is expected to triple in size to $20 billion by 2015, making it one of the top 10 markets globally. However, India faces some challenges like increasing its regulatory reputation and infrastructure to fully capitalize on the growing clinical research industry.
Lec 4 nutrition therapy that apply to specific situationsSiham Gritly
This document provides dietary advice and nutrition therapy for managing diabetes and related complications. It discusses recommendations for heart health, hypertension, dyslipidemia, pregnancy, the elderly, ethnic groups, and eating disorders. Specific advice is given for limiting saturated fats, sodium, added sugars and refined grains while emphasizing fruits, vegetables, whole grains, nuts seeds and plant-based oils. Tight glycemic control and medical nutrition therapy are important for improving health outcomes and reducing risks of diabetes complications.
The document provides a history of clinical trials and discusses several important studies that helped establish modern ethics guidelines for human subject research. It describes the unethical medical experiments performed by Nazi doctors on concentration camp prisoners. It then discusses the Nuremberg Code established after World War 2 that set the first comprehensive standards for ethical clinical research. Several controversial US studies from the mid-20th century are also summarized, including the Tuskegee Syphilis Study and experiments that deliberately infected children. This led to increased regulations and standards like the Belmont Report to better protect human research participants.
8 principle of epidemiology 11 community medicineSiham Gritly
Epidemiologic methods are used to identify disease risk factors and determine optimal treatments. There are two main types of epidemiologic studies: observational studies and experimental studies. Observational studies include descriptive studies, which observe disease distribution, and analytical studies like cohort and case-control studies, which analyze associations between exposures and disease. Experimental studies include randomized controlled trials, which randomly assign participants to test interventions, and non-randomized trials.
Application of a test or a procedure to large number of population who have no symptoms of a particular disease for the purpose of determining their likelihood of having the disease.
This document provides an introduction to epidemiological studies. It defines epidemiology as the study of disease distributions in populations and factors that influence distribution. It describes the hierarchy of evidence in epidemiology, including descriptive and analytical studies. Descriptive studies like case reports and prevalence surveys describe disease patterns, while analytical studies test hypotheses. The main analytical study designs are cross-sectional studies, case-control studies, and prospective cohort studies. Each design differs in sampling, time orientation, and ability to infer causality. Cross-sectional studies measure prevalence, case-control studies infer causality retrospectively, and prospective cohort studies follow exposed groups over time to measure incidence.
The document discusses randomized controlled trials (RCTs), which are considered the gold standard for evaluating causal relationships. It describes key aspects of RCTs such as randomization methods, blinding, allocation concealment, study populations, interventions, follow-up, and outcome assessment. RCTs follow a strict protocol and involve randomly allocating participants into study and control groups to receive different interventions/exposures. The results are then compared to determine the effectiveness of the new treatment or exposure being tested.
Clinical trials have a long history dating back thousands of years to ancient civilizations like Egypt, China, and India. In the early centuries AD, Hippocrates established the foundations of modern medicine by emphasizing clinical observation and documentation. During the Middle Ages and Renaissance, universities and hospitals advanced medicine. The 17th-18th centuries saw important early clinical trials on treatments for scurvy and the development of vital statistics. The 19th century brought large clinical observations and trials establishing germ theory and anesthesia. Major advances in the 20th century included regulations for ethics and informed consent in response to abuses and the growth of pharmaceutical industry-funded drug trials.
This document provides an overview of diagnostic testing and assessing diagnostic accuracy. It defines key concepts like sensitivity, specificity, predictive values, and likelihood ratios. Sensitivity measures the ability of a test to detect true positives, or people with the disease. Specificity measures the ability to detect true negatives, or people without the disease. Positive and negative predictive values depend on disease prevalence and estimate the probability of actual disease given a test result. Likelihood ratios quantify how much a test result changes the odds of disease. The document uses examples to demonstrate calculating and interpreting these performance measures.
Clinical trials have a long history dating back to Avicenna in the 11th century who established principles for testing drug effectiveness. Modern clinical trials involve extensive pre-clinical testing followed by 4 phases of human trials. Phase I trials in healthy volunteers establish safety. Phase II trials in patients provide preliminary efficacy and safety data. Phase III trials involve thousands of patients to confirm efficacy and monitor side effects. Phase IV occurs after approval to further monitor long-term safety. Randomization, blinding, and use of control groups aim to reduce bias in trial design and interpretation of results.
This document provides an overview of key statistical concepts for medical research including:
- Common measures like mean, standard deviation, confidence intervals, and p-values.
- Study designs such as randomized controlled trials.
- Tests for comparing groups like t-tests, ANOVA, and chi-square tests.
- Measures of disease frequency and test accuracy like sensitivity and specificity.
- The importance of understanding statistics for medical research and exams.
- Examples of choosing the appropriate statistical tests based on the study design and variables.
In 3 sentences or less, it orients the reader to fundamental epidemiological and biostatistical concepts for medical research and exam preparation.
The document discusses key concepts related to screening in preventive medicine. It defines screening as tests or examinations applied to apparently healthy individuals to detect disease in early stages. The biggest challenges are distinguishing individuals with and without disease given many diseases exist on a spectrum. An ideal screening test is inexpensive, easy to use, acceptable, valid, reliable and has high yield. The criteria for screening include the disease being an important health problem with a long preclinical stage and treatability. Screening programs must be continually evaluated to ensure benefits outweigh costs.
This document discusses key concepts regarding diagnostic and screening tests. It covers validity measures like sensitivity, specificity, predictive values, and receiver operating characteristic curves. It also addresses reliability through percent agreement and kappa statistics. The document contrasts sequential versus simultaneous use of multiple tests and examines how prevalence impacts predictive values. Finally, it outlines important factors for evaluating screening tests such as disease characteristics, test properties, and societal considerations.
This document describes different types of epidemiological study designs, including observational studies and experimental studies. It provides details on descriptive and analytical observational studies such as case reports, case series, cross-sectional studies, cohort studies, and case-control studies. Key aspects of study design covered include selection of cases and controls, measurement of exposure status, and measures of association such as odds ratios.
The document provides an overview of anger management. It defines anger, discusses how anger affects the body physically, and explains common signs of anger. It also explores reasons for expressing anger and how anger can negatively impact relationships. Finally, the document outlines steps for effectively dealing with angry feelings, such as relaxation techniques and improving communication skills, and preventing angry outbursts.
All about Clinical Trials_Katalyst HLSKatalyst HLS
Introduction to All about Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
This document outlines a presentation on clinical epidemiology. It begins with an introduction to clinical epidemiology, noting that it was introduced in 1938 as a "new basic science for preventive medicine" and shifted its focus to individual patients in the 1960s. The document then defines clinical epidemiology as "the science of making predictions about individual patients by counting clinical events in similar patients." It discusses why clinical epidemiology is important for clinical decision making and avoiding bias. The rest of the document outlines topics to be covered, including uses of clinical epidemiology, sensitivity and specificity, predictive values, ROC curve analysis, and likelihood ratios.
This document provides an overview of epidemiology and public health planning principles. It defines epidemiology as the study of distribution and determinants of health problems in populations and its application to control such problems. The key objectives of epidemiology are described as understanding disease causation, testing hypotheses, evaluating intervention programs, and informing public health administration. Effective public health planning requires defining goals, objectives, strategies, approaches, and approaches for monitoring and evaluation. Descriptive epidemiology involves observing the basic features of disease distribution by person, place, and time to identify problems and plan services. Developing hypotheses about potential causes involves interrogating usual suspects and looking for clues in patterns of who, where, and when individuals become ill.
Randomized controlled trials (RCTs) are experimental studies that assess the effect of an intervention by comparing outcomes between those who receive the intervention and a control group. RCTs minimize bias by randomly assigning participants to groups and concealing group assignments. Key factors in RCTs include sufficient sample size, stratified randomization to balance groups, blinding participants and assessors, and accounting for attrition. RCTs allow for causal inferences but have disadvantages like difficulty with some ethical questions and dropout.
This document defines and describes cohort studies. It notes that a cohort study is an analytical study used to provide evidence for or against an association between a suspected cause and disease. It examines populations that are exposed versus unexposed to a potential causative factor and follows them over time to compare disease incidence. The document outlines the key elements of cohort studies, including selection of study subjects, obtaining exposure data, follow up, analysis and comparison groups. It also discusses types of cohort studies, their advantages and disadvantages, examples, and potential biases.
This document provides an overview of clinical trials, including their purpose, classifications, terminology, design, phases, ethics, and protections for participants. Some key points:
- Clinical trials test interventions like drugs or procedures and compare them to standard practices or placebos. They progress through phases to test safety and effectiveness.
- There are three main types of research studies: observational studies that compare groups, analytic studies that test therapies, and clinical trials which are considered the "gold standard" experimental study.
- Protections like informed consent and institutional review boards ensure ethical treatment of human subjects and that risks are reasonable compared to potential benefits. Oversight protects participants' rights and welfare.
This document discusses various study designs and methodologies used in quantitative research. It begins by outlining the objectives and possible subsections of a methodology section. It then discusses study area, period, and population. The document explains how to choose study designs and describes descriptive, case-control, cohort, experimental, and mixed methods designs. It provides details on variables, sampling techniques, data collection tools, and analyses. Overall, the document serves as a guide for planning and conducting quantitative research studies.
Clinical trials are important for testing new medical treatments and determining their value. There are various phases of clinical trials, beginning with Phase 0 and Phase 1 safety trials with small groups, then Phase 2 dosage and efficacy trials with larger groups, and finally Phase 3 confirmatory trials with thousands of participants across many sites. Well-designed clinical trials utilize controls, randomization, blinding, predefined endpoints and stopping rules to reliably establish if new treatments are effective and safe for patients.
CCSC6142 Week 3 Research ethics - Long Hoang.pdfMyThaoAiDoan
The document discusses ethics in human research, outlining three key principles from the Belmont Report - respect for persons, beneficence, and justice. It provides examples of major historical events that shaped modern research ethics like the Nuremberg Code, Declaration of Helsinki, and Tuskegee Syphilis Study. The document also discusses how these principles apply to informed consent, assessing risks and benefits of research, and fair selection of study participants.
2. Unit 3 Part II - (c) Cross-sectional & longitudinal study 2022.9.19.pdfAshesh1986
Cross-sectional and longitudinal studies are two important observational study designs used in epidemiology. A cross-sectional study collects data on exposures and outcomes from a population at a single point in time, allowing researchers to examine the prevalence of diseases or risk factors. While easy to conduct, cross-sectional studies cannot determine causality. Longitudinal studies follow the same group of people over time, enabling researchers to better establish temporal relationships and causality but requiring more resources. Examples are provided to illustrate the differences between cross-sectional and longitudinal study designs.
A clinical trial is a controlled experiment conducted in humans to test new interventions such as drugs or devices. James Lind conducted the first systematic clinical trial in 1747 to test treatments for scurvy. Since then, clinical trials have evolved to their modern form involving control groups, randomization, and different phases. Clinical trials are conducted in four phases - Phase I tests safety in small groups, Phase II explores efficacy and optimal dosing, Phase III tests efficacy in large groups, and Phase IV occurs after approval to further monitor safety. Clinical trials are needed to develop and regulate new medical interventions and provide high-quality evidence on benefits and risks.
This document provides an overview of randomized controlled trials (RCTs). It begins with an introduction to RCTs, describing them as the gold standard for evaluating health care technologies. It then covers key aspects of designing and conducting RCTs, including developing a protocol, selecting and randomizing study populations, manipulating variables, follow-up, assessment, types of RCTs based on design and use, and ethical considerations. RCTs aim to provide scientific evidence of causal relationships and evaluate interventions through random assignment and control groups.
The document summarizes information about clinical trials and Clinical Trials Ontario (CTO). CTO aims to strengthen Ontario's clinical research capabilities by streamlining ethics reviews and trial agreements. It also works to increase public awareness of clinical trials and encourage participation. The summary describes key aspects of clinical trials such as phases, protocols, approval processes, and considerations for potential participants. Contact information is provided for CTO and the Canadian Cancer Survivor Network.
This document provides an overview of ethical issues in medical research. It discusses the history of unethical human experimentation including the Nazi experiments and the Tuskegee Syphilis Study. It outlines key documents that established ethical research standards like the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The Belmont Report identified three core ethical principles: respect for persons, beneficence, and justice. It also discusses the role of institutional review boards in protecting research participants and reviewing research proposals to ensure compliance with ethical standards.
The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles, or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context, “research” includes both medical and behavioral studies pertaining to human health. Usually “research” is modified by the adjective “biomedical” to indicate its relation to health.
This document provides an overview of experimental epidemiology. It begins with the introduction and history of randomized controlled trials (RCTs) including some of the earliest planned trials in the 15th and 18th centuries. It then describes the typical steps in an RCT: drawing up a protocol, selecting and randomizing populations, implementing interventions, follow up, and assessing outcomes. Next, it discusses types of RCTs including clinical, preventive, risk factor, and health services trials. The remainder of the document outlines threats to internal validity like history, maturation, testing, and placebo effects that can undermine the conclusions of an experimental study.
This document provides an overview of case control studies in epidemiology. It defines a case control study as a retrospective study that compares cases (people with a disease or condition) to controls (people without the disease or condition) to determine risk factors for the disease. The key steps outlined are: selection of cases and controls from the same study base; matching cases and controls on important characteristics; measuring exposure to suspected risk factors in the same way for both groups; and analyzing the data to compare exposure rates between cases and controls and estimate disease risk associated with exposure. Advantages are that case control studies are efficient for rare diseases, but limitations include potential for selection and recall bias.
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) that was held in Amman in June 2014.
This presentation outlines the ethical issues in research, especially the international research in low-middle income countries
This document describes different types of medical studies, including observational and experimental studies. It provides details on clinical trials, noting that they are the gold standard as they provide the greatest justification for concluding causality. The document outlines different types of observational studies like descriptive, analytical, cross-sectional, longitudinal, retrospective, and prospective studies. It also explains key aspects of experimental studies like clinical/community trials, with details on samples, randomization, interventions, controls, and measuring outcomes.
The document discusses the scientific and legal/procedural aspects of clinical trials. It defines clinical trials and describes the different phases of clinical trials (Phase I-IV). Phase I trials test safety in healthy volunteers, Phase II evaluates dosing and side effects in patients, Phase III tests efficacy in large patient groups, and Phase IV involves post-marketing surveillance. Clinical trials must follow scientific protocols and obtain regulatory and ethics approvals to protect participants. Placebos and blind/double-blind designs help ensure trial validity. The roles of investigators, sponsors, ethics committees and regulatory authorities are outlined to legally and ethically conduct clinical research.
Clinical trials involve testing investigational drugs or medical devices on humans to determine safety and efficacy. They are conducted in phases, starting with small healthy volunteer groups (Phase I) to test safety, then expanding to larger patient groups (Phase II) to determine dosing and side effects, and finally large multi-site trials (Phase III) to assess efficacy. Clinical trials require approval from ethics committees and regulatory authorities, and all participants must provide informed consent. Placebos are often used to blind both participants and researchers to reduce bias. Randomization assigns participants randomly to treatment or control groups. Together, these scientific and legal/procedural aspects aim to ethically and rigorously evaluate new treatments.
This document discusses different study designs used in epidemiology, including observational and experimental designs. Observational designs include descriptive studies like case reports and cross-sectional studies, and analytical studies like case-control and cohort studies. Experimental designs include randomized controlled trials (RCTs). Case reports provide detailed descriptions of individual cases but lack comparisons. Cross-sectional studies examine exposures and outcomes simultaneously. Case-control studies compare exposures between cases and controls. Cohort studies follow groups over time to compare outcomes. RCTs randomly assign interventions to evaluate efficacy and safety.
2. NY/VI AETC
Overview
• Purpose of Research Studies
• Classifications of Epidemiological Research
• Basic Research Terminology
• Features of Clinical Trials
• Design/Protocol
• Phases of a Study
• Ethics
• Protection of Participants
• Contributions of Clinical Trials
• Participating in a Trial
• Conclusion & Take Home Message
3. NY/VI AETC
Overview to Research Studies
Why Do Research Studies?
• To collect data on usual and unusual
events, conditions, & population groups
• To test hypotheses formulated from
observations and/or intuition
• Ultimately, to understand better one’s
world and make “sense of it”
4. NY/VI AETC
Overview to Research Studies
• Various types of research studies
• Many classified as “Epidemiological
Studies”
Epidemiology often is defined as:
The study of the distribution of a disease or
condition in a population and the factors that
influence that distribution.
5. NY/VI AETC
Classifications of Research Studies:
Three Main Types
Observational Studies:
• Groups are studied & contrasts made between groups
• The observed data collected are analyzed
Analytic Studies:
• Also called Experimental
• Study the impact of a certain therapy
• Ultimately the investigator controls factor being studied
Clinical Trial:
• Considered the “true” experimental study
• “Gold Standard” of clinical research
• Often a prospective study that compares the effect and value
of an intervention against a control in human subjects
6. NY/VI AETC
Another Classification System
• Non-directed Data Capture
• Ex: Vital Statistics
• Directed Data Capture & Hypothesis
Testing
• Ex: Cohort Studies, Case Control Studies
• Clinical Trials
• Ex: Investigation of Treatment/Condition
• Ex: Drug Trials
7. NY/VI AETC
The Different Study Designs
• Case-control • Cohort
• Case Reports • Case Series
• Outcomes Based: • Survey Research:
Quality of Life Questionnaires
Decision analysis Polls
Economic Analysis Surveys
• Meta Analyses
• Survival Analysis
• Randomized Clinical Trial
8. NY/VI AETC
Basic Research Terminology
• Retrospective: Refers to time of data
collection
• Prospective: Refers to time of data
collection
• Case Control Study: Persons w/ disease
& those w/out are compared
• Cohort Study: Persons w/ and/or w/out
disease are followed over time
9. NY/VI AETC
Terminology (Cont.)
• Cross-sectional Study: Presence or
absence of exposure to possible risk factor
measured at one point in time. Prevalence
obtained.
• Prevalence: The # of new cases and
existing cases during specified time period.
• Incidence: The # of NEW cases per unit of
a population at risk for disease occurring
during stated time period.
10. NY/VI AETC
Historical Minute
First “Clinical Trials”
• Clinical Trials have a long history – even
if not acknowledged as Clinical trials
• Formal record of clinical trials dates back
to the time of the “Trialists”:
• Dr. Van Helmont’s proposal for a therapeutic
trial of bloodletting for fevers [1628]
• Dr. Lind’s, a ship surgeon, trial of oranges &
limes for scurvy [1747]
11. NY/VI AETC
Historical Minute
First “Clinical Trials”
Historical Highlights of Drug Trials
• 1909: Paul Ehrlich - Arsphenamine
• 1929: Alexander Fleming - Penicillin
• 1935: Gerhard Domagk - Sulfonamide
• 1944: Schatz/Bugie/Waksman – Streptomycin
• By 1950, the British Medical Res. Council
developed a systematic methodology for studying
& evaluating therapeutic interventions
12. NY/VI AETC
Core Components of Clinical Trials
• Involve human subjects
• Move forward in time
• Most have a comparison CONTROL group
• Must have method to measure intervention
• Focus on unknowns: effect of medication
• Must be done before medication is part of
standard of care
• Conducted early in the development of
therapies
13. NY/VI AETC
Core Components of Clinical Trials
• Must review existing scientific data &
build on that knowledge
• Test a certain hypothesis
• Study protocol must be built on sound &
ethical science
• Control for any potential biases
• Most study medications, procedures,
and/or other interventions
14. NY/VI AETC
The Possible World of Clinical
Trial Designs
• Randomized/blinded trial
• Randomized/double blinded trial
• Non-randomized concurrent controlled
trial
• Placebo trial
• Historical controlled trial
• Crossover Trial
• Withdrawal trial
15. NY/VI AETC
Simplified
• Randomized:
Schemes used to
assign participant to
one group
o Ex: Every 3 gets higher
dose
• Nonrandomized: All
with Hep. C = cases;
others = controls
• Protocol: Study
design - instructions
• Blinded: Participants
do not know if in
experimental or control
group
• Double Blinded:
Participants AND staff
do not know group
assignment
• Placebo: Inactive pill
w/ no therapeutic value
16. NY/VI AETC
Components of Clinical Trial Protocols
• Investigating two or more conditions so
have two(+) groups
• Ex: drug vs. placebo; medicine vs. surgery;
low dose vs. high dose
• Specific inclusion/exclusion criteria
• Sample size & power calculations
• Plan re: potential biases
• Plan re: handling of attrition/loss to
follow up
17. NY/VI AETC
Study Participant Recruitment
• Identify eligible
participants
• Explain study
• Provide informed
consent
• Reassess eligibility
• Assign to one group
Participants should be told:
• May have side effects
(adverse effects)
• Time commitment
• Benefits & risks
• May withdraw at any time
• Enrollment 100%
voluntary
18. NY/VI AETC
Phases of Clinical Trials
• Most trials that involve new drugs go
through a series of steps:
– #1: Experiments in the laboratory
– #2: Once deemed safe, go through 1-4
phases
19. NY/VI AETC
Phases of Clinical Trials
• Phase I: Small group [20-80] for 1st time to
evaluate safety, determine safe dosage range &
identify SE
• Phase II: Rx/tx given to larger group [100-
300] to confirm effectiveness, monitor SE, &
further evaluate safety
20. NY/VI AETC
Phases of Clinical Trials (cont.)
• Phase III: Rx/tx given to even larger group
[1,000-3,000] to fulfill all of Phase II objectives
& compare it to other commonly used txs &
collect data that will allow it to be used safely
• Phase IV: Done after rx/tx has been marketed -
studies continue to test rx/tx to collect data
about effects in various populations & SE from
long term use.
21. NY/VI AETC
Summary of Phases I-III
# Subs. Length Purpose % Drugs
Successfully
Tested
Phase I 20 – 100 Several
months
Mainly Safety 70%
Phase II Up to
several
100
Several
months-
2 yrs.
Short term
safety; mainly
effectiveness
33%
Phase
III
100s –
several
1000
1-4 yrs. Safety, dosage
& effectiveness
25-30%
22. NY/VI AETC
Ethics of Clinical Trials:
Protection of Participants
3 ethical principles guide clinical research:
• Respect for Persons: Treatment of person
as autonomous
• Beneficence: Issue re: potential conflict
between good of society vs. individual
• Justice: Treatment of all fairly & all
equally share benefits & risks
23. NY/VI AETC
Ethical Norms of Clinical Trials
Sound study designs take into account:
• Randomization or sharing of risks
• Proper use of placebo
• Processes to monitor safety of rx/tx
• Competent investigators
• Informed consent
• Equitable selection of participants
• Compensation for study related injuries
24. NY/VI AETC
Ethical Issues:
Protection of Human Subjects
• Rely on integrity of Investigator but outside groups
also have oversight
• Participants’ rights protected by Institutional Review
Boards [IRBs]
o An IRB is defined as: "any board, committee or
other group formally designated by an institution to
review, to approve the initiation of, and to conduct
periodic review of biomedical research involving
human subjects"
25. NY/VI AETC
Human Subjects’ Protection
IRB responsible for such tasks:
• Review research to ensure that potential
benefits outweigh risks
• Develop and issue written procedures
• Review research for risk/benefit analysis &
proper protection of subjects
• Issue written notice of approval/disapproval to
the Investigator
• Review and respond to proposed protocol
changes submitted by the Investigator
26. NY/VI AETC
Human Subjects’ Protection
• Review reports of deaths, and serious and
unexpected adverse events received from
the Investigator
• Conduct periodic continuing review of
the study, study risks, selection of
subjects, privacy of
subjects, confidentiality of data, and the
consent process
IRB Responsibilities (continued):
27. NY/VI AETC
Historical Minute:
Origin of IRBs & Human Subject Code
• Attention to protecting participants began after
WWII w/ the Nuremberg Trials (1947)
• Out of those trials, key points were codified
28. NY/VI AETC
Historical Minute:
10 Key Points
• Voluntary informed consent
• Experiment must be for the good of society, & results not
obtainable by other means
• Experiment should be based upon prior animal studies
• Physical & mental suffering & injury should be avoided
• No expectation that death/disabling injury will occur from
the experiment
• Risk vs. benefit
• Protect subjects against injury, disability, or death
• Only scientifically qualified persons to be involved
• Subject can terminate her/his involvement
29. NY/VI AETC
Historical Minute:
Origin of IRBs & Human Subject Codes
• Since 1947, additional subject protection
requirements developed & implemented
• Latest additions: Year 2000 - President
Clinton & DHHS Secretary Shalala
announced additional study requirements
related to:
informed consent training req. adverse events
conflict of interest civil monetary penalties
improved monitoring of Phase I & II trials
30. NY/VI AETC
Informed Consent:
A Part of Human Subject Protection
Objectives of Informed Consent
To Ensure:
• Voluntariness
• Comprehension
• Information
To Demonstrate That:
• Person freely gave consent to participate
• Consent given by a competent person
• Person has been given all information
• Person knows this is research – not treatment
31. NY/VI AETC
Components of Informed Consent
• Must Include the Following Information:
• Why research being done?
• What researchers want to accomplish
• What will be done and for how long
• Risks & benefits of trial
• Other treatments available
• Can withdraw from trial whenever desire
• Compensation for unexpected injuries
32. NY/VI AETC
Vulnerable Populations
Groups thought not to have autonomy to give informed
consent:
• children
• mentally impaired, individuals with dementia
• Prisoners
OR
Who may be unduly influenced to participate:
• students
• subordinates
• pregnant women (actually, the fetuses)
• patients (care-giver vs. researcher)
33. NY/VI AETC
Vulnerable Populations
To safe guard these groups, special
requirements such as:
• Only parent can consent for minor
• Consents must be in subject’s native lang.
• Prisoners: only some types of research
allowed
34. NY/VI AETC
Inclusion in Clinical Trials
• NIH Revitalization Act of 1993: Guidelines
that require inclusion of women &
minorities in clinical studies
• New guidelines stipulate that:
o Women & minorities are to be included in all
human subject research
o They are to be included in Phase III trials to
allow sufficient power to note differences
o Cost cannot be a barrier
o Outreach activities must take place to include
& follow these groups
35. NY/VI AETC
Inclusion in Clinical Trials
• Historically women were excluded if of
reproductive age (ages 18-45)
• Fear of harm to potential unborn child
• In essence, excluded MAJORITY of
women
• New guidelines eliminates this stipulation
36. NY/VI AETC
Issues in Clinical Trials:
Use of Placebo Trials
On international realm, 1999 “Declaration of Helsinki”
revised to address use of placebos:
• Placebos not ethical in virtually all studies that involve
diseases with PROVEN tx
• Remain ethical in trials where no proven tx
• Revisions due to controversy over use of placebos in
attempting to find easy/cheap way to reduce HIV
perinatal transmission
• 1998 study in Ivory Coast, Uganda, & Thailand:
HIV+ pregnant women given either placebo or
shorter course of AZT
37. NY/VI AETC
Participation in Clinical Trials
Why Some Participate:
• Give back to society
• Exhausted all other txs
• Health care services
• Payment & incentives
• Support
• Others??
Why Some Do Not?
• Mistrust of studies
• Do not want to be
“guinea pig”
• Do not meet criteria
• Cannot give up time for
study visits
• Barriers: lang., distance
38. NY/VI AETC
Taking Part in Research Studies:
Questions to Ask
• What is study about?
• What are the goals?
• Study sponsor?
• Participant input into
protocols?
• Inclusion criteria?
• Benefits & risks
• Is there an incentive?
• How protected from
harm?
• What is required: # study
visit & what occurs?
• What happens after study
is over?
• How results will be
disseminated?
39. NY/VI AETC
The Impact of Studies
• Some clinical trials have been critical to
patient health & provision of health care
• For instance:
o Protocol 076: HIV perinatal transmission
o 1st trial of AZT
o Various cancer treatments
o Development of other HIV related
medications like PIs
40. NY/VI AETC
The Impact of Studies
Other clinical trials have not been as
successful for a variety of reasons:
• Medications did not work as in
laboratory
• Loss to Follow-Up of too many patients
• Harmful substance
• Unethical & poorly conducted study (Ex:
Tuskegee Study & recent Gene
Replacement Study)
41. NY/VI AETC
Conclusions &
Take Home Message
• Clinical trials often yield important results that
affect health and well being
• Must follow guidelines & protocol
• Must ensure well-being of participant
• Clinical trials are susceptible to human error
either on part of investigator or patient
• Research is soft science