POP-REFINE: A Comprehensive Framework for Evaluating and Optimizing Representativeness in Clinical Trials.

ABSTRACT: Clinical research has historically failed to include representative levels of historically underrepresented populations and these inequities continue to persist. Ensuring representativeness in clinical trials is crucial for patients to receive clinically appropriate treatment and have equitable access to novel therapies; enhancing the generalizability of study results; and reducing the need for post-marketing commitments focused on underrepresented groups. As demonstrated by recent legislation and guidance documents, regulatory agencies have shown an increased interest in understanding how novel therapies will impact the patient population that will receive them. Despite these efforts, a systematic approach to measure and optimize representativeness remains underdeveloped. Here, we introdu

SUBMITTER: Benedum CM 

PROVIDER: S-EPMC11924170 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature