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Epidemiology & Survival Analysis
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Module 4
Design and Interpretation of Clinical Trials
1
Clinical Trials: Ethics and Regulatory Phases
Describe the ethical principles and regulatory phases (I-IV) of clinical trials.
2
Phases of Clinical Trials
Describe the objectives of Phase I (safety), Phase II (efficacy), and Phase III (comparative efficacy) trials.
3
Phase III Trial Design: Randomization, Blinding, and Controls
Describe key design features of Phase III trials, including randomization, blinding, and control groups.
4
Understanding Statistical Power and Sample Size Calculation
Explain the importance of statistical power and the factors influencing sample size calculations.
ITT vs. Per-Protocol Analysis: Key Differences
Distinguish between intention-to-treat and per-protocol analysis principles.
6
Understanding Phase III Trial Results
Interpret primary efficacy and safety results from a published Phase III trial.
7
Assessing Clinical Trial Validity
Evaluate the internal and external validity of a clinical trial.
Previous module
Addressing Confounding and Effect Modification
Next module
Fundamentals of Survival Analysis