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Codex of clinical research
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Comparator

From Codex of clinical research

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

References

  1. 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

External links