Regulatory Affairs Certification (RAC) Practice Exam

What phase of clinical trials typically involves a larger number of patients to confirm efficacy and monitor side effects?

1. Phase 1

2. Phase 2

3. Phase 3

4. Phase 4

The correct answer is: Phase 3

The phase of clinical trials that typically involves a larger number of patients to confirm efficacy and monitor side effects is Phase 3. This phase is crucial as it aims to gather more comprehensive data about the drug's effectiveness across diverse populations and conditions, as well as further assess its safety. During Phase 3 trials, the treatment is compared against standard care or a placebo in a randomized manner. This helps in establishing a clear understanding of the drug's benefits and risks, thus supporting regulatory approval applications. The larger patient population allows for a more robust assessment of the treatment's therapeutic effects and detection of any rare side effects that may not have been observed in earlier phases, which had smaller sample sizes. Phase 1 typically involves a small group of healthy volunteers to assess safety and dosage. Phase 2 expands the study to patients who have the condition but is still relatively small in number, focusing mainly on efficacy and side effects. Phase 4 occurs after the drug has been approved and marketed, involving post-marketing surveillance to monitor long-term effectiveness and safety in a broader patient population.