CITI Training Practice Exam

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What best describes the clinical phase of a study enrolling 55 patients in each arm for a new drug versus aspirin postoperative pain control?

Phase 1
Phase 2
Phase 3
Phase 4

The correct answer is: Phase 2

The clinical phase of a study enrolling 55 patients in each arm for a new drug versus aspirin postoperative pain control is best described as Phase 2. This phase focuses on evaluating the safety and efficacy of a new drug, typically with a larger sample size than Phase 1. Phase 3 is usually reserved for larger, more diverse patient populations, while Phase 4 is for post-market surveillance and ongoing monitoring of the drug's effects. Phase 1 is primarily concerned with determining the maximum safe dose of the drug.