Good Clinical Practice (GCP) Practice Exam

A comparator in the context of a clinical trial refers to an investigational or marketed product that is used as a reference against which the effects of a new treatment or intervention can be measured. In clinical trials, comparators are critical for determining the efficacy and safety of the new product being tested, since they allow researchers to establish a baseline for comparison.

When using a comparator, the outcomes of the new treatment can be evaluated not only in terms of efficacy but also in relation to any potential benefits or harms compared to the existing standard of care or a placebo. This helps ensure that the results are meaningful and can guide healthcare decisions.

In contrast, a placebo is just one type of comparator, but the term "comparator" is broader and includes any relevant standard treatment, thus allowing for comparisons that could also include active medications or other therapeutic options. The other options reflect aspects that do not directly align with the definition of what a comparator is within the context of clinical trials.