Certified Clinical Research Coordinator (CCRC) Practice Exam

What is a "Comparator" in clinical trials?

1. A marketing strategy for clinical products

2. An investigational or marketed product used as reference

3. The primary medication being tested

4. A regulatory requirement for drug approval

The correct answer is: An investigational or marketed product used as reference

A "Comparator" in clinical trials refers to an investigational or marketed product that serves as a reference point against which the efficacy and safety of the experimental treatment are measured. In comparative studies, such as randomized controlled trials, the comparator allows researchers to evaluate the effects of a new treatment by comparing its outcomes with those of a standard treatment or placebo. This helps to determine how well the new intervention performs relative to existing therapies. In deciding the effectiveness of treatments in a clinical trial, the comparator is essential in establishing whether the new therapy has a clinically meaningful advantage or poses additional risks in comparison to what is already available in the market. Thus, the role of a comparator is fundamental in providing evidence necessary for regulatory bodies to assess the new treatment's performance and potential market approval.