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

What is the main purpose of Phase III clinical trials?

1. To evaluate safety in a larger population

2. To determine the ideal dose for a new treatment

3. To compare a new treatment to existing treatments or placebo

4. To gather post-marketing surveillance data

The correct answer is: To compare a new treatment to existing treatments or placebo

The primary purpose of Phase III clinical trials is to compare a new treatment to existing treatments or a placebo. This phase is crucial in determining the effectiveness of the new intervention within a larger patient population. By conducting these trials, researchers can assess not only how well the treatment works compared to what is already available but also gather data on its safety and side effects in a more diverse group of participants. Phase III trials often involve large numbers of patients and are conducted across multiple sites to ensure that the results are robust and representative. The comparative nature of these studies helps regulatory agencies, like the FDA, make informed decisions about whether to approve a new treatment for public use based on its relative efficacy and safety profile compared to standard care or placebo. This rigorous evaluation is essential for establishing guidelines for the treatment of a condition and ensures that any new therapy adds value to patient care. In contrast, evaluating safety in a larger population typically occurs in Phase II trials, determining the ideal dose is a focus of earlier phases, and post-marketing surveillance data collection happens after a treatment has been approved and is available in the market.