Comparator (Product) is a standard or reference product used in clinical trials to assess the safety, efficacy, or other characteristics of an investigational product, typically a new drug or medical treatment. This reference product may be an established medication or a placebo, depending on the study design. Comparators enable researchers to make valid comparisons between the investigational product and an existing standard, aiding in the evaluation of the new product's performance.
Definitions
ICH E6
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial [1].
See also
Links to this page
- Glossary:Comparator (redirect page) (← links)
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf