R-index: a standardized representativeness metric for benchmarking diversity, equity, and inclusion in biopharmaceutical clinical trial development.

ABSTRACT:

Background

Diversity, equity, and inclusion pertaining to race, ethnicity, and related concepts have historically been underrepresented in clinical trials for pharmaceutical drug development, although this is an increasing topic for regulators, payers, and patient advocacy groups. We aimed to develop a summary statistical measure to assess such representativeness.

Methods

A statistical measure using population demographic parameters derived from performance metrics through verbal autopsy research was proposed for using population frameworks in the UK. The summary measure, R-index, was demonstrated using simulation data with population frameworks from the UK (116 Roche UK clinical trials 2013-2022) and then using published clinical trial results (NCT02366143 [March 1, 2015-Se

SUBMITTER: James SL 

PROVIDER: S-EPMC11833413 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature