Certified Research Administrator Practice Exam

What phase of a clinical trial involves a new drug given to a large group of 100-300 to observe effectiveness and evaluate safety?

1. Phase I

2. Phase II

3. Phase III

4. Phase IV

The correct answer is: Phase II

The description provided corresponds to Phase II of a clinical trial, where a new drug is administered to a larger group of participants, typically ranging from 100 to 300 individuals. This phase primarily focuses on assessing the drug's effectiveness and further evaluating its safety after initial findings from Phase I trials. During Phase I, the primary goal is to assess the safety and dosage of the drug in a smaller group, usually consisting of 20 to 80 participants. Conversely, Phase III expands on Phase II results and involves a much larger population to confirm effectiveness, monitor side effects, and compare it to standard or equivalent treatments. Phase IV occurs after the drug has been approved and is on the market, involving post-marketing surveillance to track long-term effects and overall performance in broader populations. Understanding these distinctions is crucial for grasping the overall framework and objectives of clinical trials.