Endpoints in clinical research
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This document discusses various types of endpoints used in clinical research trials. It defines endpoints as the final outcomes measured to assess a drug's efficacy or safety. Endpoints are classified as primary or secondary. Primary endpoints directly answer the main trial questions, while secondary endpoints are analyzed post-hoc. Endpoints can also be hard or soft, composite, surrogate, clinical, or related to mortality, morbidity, quality of life, or patient-reported outcomes. The document provides examples of endpoints used in oncology trials like overall survival and progression-free survival.
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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.
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1) The document discusses a lecture on evidence-based medicine (EBM) and critical appraisal.
2) EBM involves integrating the best available research evidence with clinical expertise and patient values. It includes formulating clinical questions, searching for evidence, appraising research, and applying the evidence to patient care.
3) The lecture reviews the principles of EBM and critical appraisal, including how to formulate answerable clinical questions using the PICO framework, search for evidence, and appraise different types of research studies.
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Randomized controlled trials (RCTs) are considered the gold standard for evaluating clinical evidence because random assignment of subjects to experimental and control groups minimizes bias. RCTs manipulate the exposure by having the investigator assign subjects to different treatment groups. This allows for a direct assessment of causality between the exposure and outcome. Well-designed RCTs provide the highest quality level of evidence according to most evidence rating systems. However, RCTs also have some disadvantages such as complexity, expense, and ethical challenges of experimental research.
Xx..health related quality of lif e
This document discusses health-related quality of life (HRQOL) and how it is measured. Some key points:
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This document discusses evidence-based laboratory medicine (EBLM) and its key components. It explains that EBLM involves the conscientious, explicit and judicious use of current best evidence in making well-informed decisions in laboratory medicine. The main components of EBLM are individual expertise, best external evidence, and patient values and expectations. It also discusses how to practice EBLM by asking questions, acquiring evidence, critically appraising the evidence, and applying the information while evaluating the process.
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inclusion &exclusion criteria.pptx
The document discusses inclusion and exclusion criteria, as well as primary and secondary outcome measures for research studies. It provides examples of factors that may be considered for inclusion criteria, such as participant age and health status, and exclusion criteria, such as use of certain medications. Primary outcomes are the most important measures that define the main question of the study, while secondary outcomes provide additional supportive information about an intervention's effects. An example hip fracture trial is described that specifies its inclusion criteria, exclusion criteria, and primary and secondary outcomes.
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This document discusses response variables and outcomes for clinical trials. It provides guidance on selecting appropriate response variables that adequately address the study hypothesis. Key points include:
- Response variables should be well-defined, stable, reproducible, unbiased, and ascertainable for all participants.
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This document provides an overview of clinical trials and the role of statistics within clinical research. It discusses how clinical trials allow researchers to systematically study medical treatments and make evidence-based inferences about a treatment's effects. The document outlines the key elements of clinical trials, such as using a control group, randomization, blinding, and informed consent. It also discusses the history of clinical trials and how they became the preferred method for medical research due to providing a standardized and ethical way to study human subjects compared to observational studies. Finally, the document addresses some of the ethical considerations around clinical trials, such as balancing patient welfare with gaining scientific knowledge.
Clinical Trial phases.pptx
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health outcome measure
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Endpoints in clinical research
- 1. ENDPOINTS IN CLINICAL RESEARCH BY: DEEPAK SHARMA NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH, MOHALI
- 2. Table of Content • Introduction • Definition • Classification of endpoint • Other type of endpoint • Endpoint in oncology • Reference
- 3. Introduction • In a clinical research trial, endpoint generally refers to objective of a study or trial. • The primary endpoint of a clinical trial is the endpoint for which subjects are randomized and for which the trial is powered. Secondary endpoints are endpoints that are analyzed for which the trial may not be powered.
- 4. Definition • In clinical studies, end point is the final outcome, the researcher needs to measure while analyzing the overall efficacy or safety of a drug. • The variable capable of providing the most clinically relevant and convincing evidence related to the primary objective of the trial.
- 5. Classification of endpoint Types of endpoint- 1. Primary vs. secondary endpoints 2. Hard vs. soft endpoints 3. Composite endpoint 4. Direct vs. surrogate endpoints
- 6. Primary endpoint • Primary endpoint measure outcomes that will answer the primary (or most important) question being asked by a trial, such as whether a new treatment is better at preventing disease-related death than the standard therapy. • Example- fall in LDL level in cardiovascular disease
- 7. Secondary endpoint • Secondary endpoints that are analyzed post hoc for which the trial may not be powered nor randomized. • Example-Mortality study following MI, Incidence of cause-specific deaths, non-fatal events/ hospitalizations.
- 8. Hard endpoint • It is measured by observation. • It is quantitative in nature. • For example- Cardiovascular studies, death or MI.
- 9. Soft endpoint • It is often qualitative in nature. • It is more subjective. • For example- reduction in morning stiffness is a soft endpoint. It is equally important in the final assessment of the therapeutic effectiveness/ safety.
- 10. Composite endpoint • A combined or composite endpoint in a clinical trial is a clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints. • If a single primary endpoint is not suitable and cannot be selected from multiple measurements associated with the primary objective, then another strategy is to combine several measures.
- 11. Surrogate endpoint • The National Institutes of Health (USA) defines surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint". • In clinical research trials, a surrogate endpoint is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship.
- 12. Other type of endpoint 1. Clinical endpoint 2. Mortality 3. Intermediate and final outcomes 4. Patient reported outcomes 5. Morbidity health-related quality of life
- 13. Clinical endpoint • In a clinical research trial, a clinical endpoint generally refers to occurrence of a disease, symptom, sign or laboratory abnormality that constitutes one of the target outcomes of the trial.
- 14. Mortality • It is important to note that endpoints may include adverse reactions that reflect on the safety of the treatment. • Adverse reactions are often collected as secondary endpoints and there is likely to be variation across studies in how adverse events are reported in terms of both detail and terminology.
- 15. Intermediate and final endpoints • An intermediate endpoint is a clinical endpoint associated with the use of a pharmaceutical such as measure of a function or of symptoms (disease-free survival, angina frequency. • It is not the ultimate endpoint of the disease, such as survival or the rate of irreversible morbid events
- 16. Patient reported outcomes • A patient reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. • It specifically refers to "self-reporting" by the patient.
- 17. Morbidity health-related quality of life • Quality of life measures constitute clinical endpoints. • HRQOL measures result from assessment of multiple dimensions related to patients’ disease and its treatment, they may be susceptible to changes due to a variety of external factors.
- 18. Endpoints in oncology 1.Overall survival It is the time from randomisation to until death from any cause of patient. 2. Progression free survival It is the time from randomization to until disease progression or death of the patient.
- 19. Reference 1. Chin R, Lee BY. Economics and patient reported outcomes, Principles and practice of clinical trial medicine. London, Amsterdam, Burlington, San Diego: Elsevier Inc; 2008:145–166. 2. Kleist P. Composite Endpoints for Clinical Trials: Current Perspectives. International Journal of Pharmaceutical Medicine. 2006; 21(3):25-30.
- 20. Contd. 3. Rauch G, Beyersmann J. Planning and evaluating clinical trials with composite time‐to‐first‐event endpoints in a competing risk framework. Statistics in medicine. 2013; 32(21):3595-3608. 4. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled?. Annals of internal medicine. 1996; 125(7):605-613.
- 21. Contd. 5. Marquis P, Caron M, Emery M-P, Scott JA, Arnould B, Acquadro C. The role of health-related quality of life data in the drug approval processes in the US and Europe. Pharmaceutical Medicine. 2011;25(3):147-160. 6. Bottomley A, Aaronson NK. International perspective on health-related quality-of-life research in cancer clinical trials: the European Organisation for Research and Treatment of Cancer experience. Journal of Clinical Oncology. 2007; 25(32):5082-5086.
- 22. Thank you