Racial and Ethnic Reporting and Representation in US Alzheimer Clinical Trials

What are the patterns and trends in racial and ethnic reporting and representation in US-based phase 3 Alzheimer disease (AD) clinical trials?In this systematic review including 71 published trials with publicly available results from 1997 to 2023, many AD trials did not report patient race or ethnicity, and when reported, practices were inconsistent and largely focused on White patients, with low representation of other racial and ethnic groups. Few trials examined treatment safety or efficacy by patient race or ethnicity; and reporting and representation showed little improvement over time.Findings indicate that persistent gaps in racial and ethnic reporting and underrepresentation in AD trials limit transparency and evaluation of treatment safety and efficacy for populations most affected by AD.

Corresponding Author: Xi Chen, PhD, Department of Health Policy and Management, Yale School of Public Health, 60 College St, New Haven, CT 06520 (xi.chen@yale.edu).

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