University:
University of Wolverhampton
Course:
4PY019 | Pharmacy
Academic year:

2024
Views:

182

Pages:

2
Author:

Sara

Clinical Trials Experiments to test efficacy and safety of new treatments James Lind Performed first clinical trial in 1753, curing scurvy with citrus fruits Lady Mary Wortley Montagu Historical figure in clinical trials Edward Jenner Historical figure in clinical trials Nuremberg Code 1949 ethical guidelines for research, emphasizing voluntary consent Declaration of Helsinki 1964 ethical guidelines for research, emphasizing informed consent Drug Development Risky, expensive, and time-consuming process Randomisation Assigning patients by chance to treatment groups to avoid bias Blinded Studies Studies where patient or physician is unaware of treatment assignment Informed Consent Ensures voluntariness, comprehension, and information in research participation Placebo Inert substance used in controlled studies for comparison Voluntary Consent Subjects' agreement to participate in research willingly Phases of Clinical Trials Sequential stages of testing new treatments for efficacy and safety Benefit and Risk Assessing the advantages and potential harm of treatments Drug Development Cost Average $55M to $800M per drug, reaching market in 7-10 years Blinded Studies Purpose To prevent bias in reporting treatment effects Unblinding Revealing treatment assignment if medically necessary before study end 1/2 Components of Informed Consent Information on why research is conducted and its purpose Arms in Clinical Trials Groups in a trial receiving different treatments Research Studies Collecting data on events, conditions, and populations for hypotheses testing Economics of Pharmaceutical Develop- Costly and time-consuming process with ment high incentives for efficiency New Treatment Types Includes drugs, combinations, surgical procedures, and device innovations Timeframe for Drug Development Average 7-10 years from initial tests to market Autonomy Ability to make independent decisions Undue Influence Coercion or pressure to participate in a study Placebo Trials Studies using placebos in absence of proven treatment Protocol 076 Study reducing HIV perinatal transmission using AZT Cytokine Release Syndrome Overreaction of immune system causing severe symptoms Phase I Trial Initial study to evaluate safety and dosage of a drug Data Safety Monitoring Ongoing safety surveillance during a clinical trial Phase IV Post-marketing surveillance for rare or adverse effects Black-Box Warning Serious warning on drug labels about potential risks 2/2