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Statistical Biology Part 2 : Epidemiology, Study Designs, Clinical Trials, Genetics Statistics & Advanced Biostatistics
Question 13 / 60
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STAT-063
What are PHASES of clinical trials (Phase I, II, III, IV)?
A. Phase I: large efficacy trial; Phase IV: safety testing
B. Phase I: safety in healthy volunteers (dose-finding); Phase II: preliminary efficacy and safety in small patient group; Phase III: definitive efficacy and safety (large RCT); Phase IV: post-marketing surveillance
C. All phases test the same things, only in different populations
D. Phase II is the most important for regulatory approval
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