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

What type of study design is most likely used if a sponsor has a new product that is believed to be as effective as an existing treatment?

1. Equivalence

2. Superiority

3. Non-Inferiority

4. Exploratory

The correct answer is: Non-Inferiority

The most likely study design used when a sponsor has a new product believed to be as effective as an existing treatment is non-inferiority. This type of study is specifically designed to determine whether the new treatment is not significantly worse than the existing treatment, within a predefined margin. Non-inferiority trials are conducted to demonstrate that the new treatment can offer equivalent benefits, thereby providing evidence that it holds its own against the standard treatment. In this context, the focus is on proving that the new product's effectiveness is not inferior to that of the existing treatment, which aligns seamlessly with the goal of the sponsor who believes in the new product's equivalence. This study design is widely used in clinical research, particularly when the aim is to show that a new drug or therapy can be considered a viable alternative while potentially offering additional benefits such as improved side effect profiles or ease of administration. This approach contrasts with superiority trials, which specifically aim to demonstrate that one treatment is better than another, and equivalence studies, which are designed to show that two treatments are essentially the same. Exploratory studies, on the other hand, are more focused on generating hypotheses rather than confirming specific differences in effectiveness.