A comprehensive overview of clinical research methodologies, emphasizing the design, conduct, and interpretation of studies, particularly the Randomized Control Trial (RCT). It discusses essential components like study designs (cohort, case-control, and RCTs), the critical role of statistical power and sample size calculation, and the interpretation of results using measures of association like relative risk (RR) and Odds Ratio (OR). Furthermore, the source addresses crucial issues such as ethical considerations in trials (including the use of placebos), the importance of recruitment and retention, and the challenges posed by bias, confounding, and the use of surrogate endpoints in establishing causal inference. Finally, the text touches on the regulatory framework, including the evolution of the FDA's requirements for drug approval following historical events, and the emerging field of implementation research.
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