Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What phase of a clinical trial is primarily focused on determining therapeutic benefit in wider populations?

1. Phase 1

2. Phase 2

3. Phase 3

4. Phase 4

The correct answer is: Phase 3

The focus of Phase 3 in a clinical trial is to determine the therapeutic benefit and safety of a new treatment in a larger and more diverse population. At this stage, the drug or intervention is tested on a significant number of participants, often with the aim of collecting enough data to demonstrate efficacy and monitor adverse reactions. This phase is critical because it helps establish how well the treatment works in comparison to standard therapies or a placebo, ensuring that the findings are robust and applicable to a general patient population. Phase 3 trials are typically randomized and controlled, which enhances the reliability of the results. If successful, the findings from this phase are crucial for regulatory submission to health authorities, leading to potential approval for wider use in clinical practice. In contrast, the earlier phases, such as Phase 1, focus more on safety and the pharmacokinetics of the treatment, while Phase 2 primarily seeks to assess the drug's efficacy and side effects in a smaller group. Phase 4 occurs after a drug has been approved and is available on the market, concentrating on long-term effectiveness and monitoring for any unforeseen effects in a broader population.