Certified Research Administrator Practice Exam

Which phase of a clinical trial focuses on assessing efficiency and safety?

1. Phase 1

2. Phase II

3. Phase III

4. Phase IV

The correct answer is: Phase III

In a clinical trial, the phase that primarily focuses on assessing efficiency and safety is Phase II. During this phase, the treatment's effectiveness is evaluated in a larger group of participants following initial safety assessments in Phase I. The goal here is to determine if the treatment has the desired effects while closely monitoring for any adverse reactions or side effects, thereby providing critical data on both efficacy and safety. Phase I trials primarily concentrate on safety and dosing rather than efficacy, using a small group of participants to test the treatment's safety profile and how it is metabolized. Phase III further evaluates the treatment's effectiveness on a much larger scale, comparing it against standard treatments to determine overall efficacy. Phase IV occurs after a treatment has been approved and involves ongoing safety monitoring and post-marketing studies to identify any long-term effects or rare side effects in broader patient populations. By understanding these distinctions, it becomes clearer why Phase II is the appropriate answer when discussing the assessment of efficiency and safety in clinical trials.