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

What do superiority studies aim to demonstrate in clinical trials?

1. That two treatments are equivalent

2. That one treatment is superior to another

3. That a treatment causes no adverse effects

4. That a treatment is safe for all patients

The correct answer is: That one treatment is superior to another

Superiority studies are designed specifically to demonstrate that one treatment is more effective than another treatment. The primary goal of these studies is to provide evidence that the experimental treatment is superior in achieving a particular outcome compared to a control or existing standard treatment. This is achieved by statistically analyzing the results to determine if the experimental treatment produces significantly better effects in terms of efficacy. In the context of clinical trials, establishing superiority can lead to important implications, including the potential for the new treatment to be adopted as a standard of care if it shows clear benefits. The design of superiority trials typically incorporates methods to minimize bias and ensure that the observed effects are indeed due to the intervention being tested. This focus on establishing an advantage over alternatives distinguishes superiority studies from other types, such as equivalence or non-inferiority studies, which have different aims regarding treatment effectiveness or safety.