Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response.

ABSTRACT: Although the number of countries participating in pivotal trials submitted to enable drug registration has nearly doubled over the past 25 years, there has not been a substantial increase in the diversity of clinical trial populations. In parallel, our understanding of factors that influence medicine response and variability has continued to evolve. The notion of intrinsic and extrinsic sources of variability has been embedded into different regulatory guidelines, including the recent guideline on the importance of enhancing the diversity of clinical trial populations. In addition to presenting the clinical and scientific reasons for ensuring that clinical trial populations represent the demographics of patient populations, this overview outlines the efforts of regulatory agencies, patient

SUBMITTER: Gross AS 

PROVIDER: S-EPMC9306578 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature