Public attention on the need for participant diversity is high, particularly in light of the recent wave of journal and governmental policies requiring studies to report varying elements of participant diversity (sex, race, age) and the FDA’s recent decisions to limit certain PrEP indications by sex. AIDS Treatment Activists Coalition (ATAC) is a US-based coalition of AIDS activists who meets regularly with pharmaceutical companies to bring an expert community perspective into the development of new HIV drugs and the utilization of HIV therapies. ATAC undertook a systematic analysis of participant diversity in Industry-sponsored studies for four active companies in HIV research and development (R&D): Gilead Sciences (Gilead), Janssen, Merck, and ViiV Healthcare (ViiV). The primary objective of this analysis was to characterize participant demographics in efficacy and registrational pharmaceutical studies (Phase II, III, IV, and Observational studies) from 2010–2020 that were sponsored by these four companies.
A systematic search of clinicaltrials.gov for any studies related to HIV drugs under development by the four companies during the study time period (2010-2020) was completed. Search results were screened for relevance. Registry listings for studies in final dataset (N=146) were reviewed, and study information (including phase, # of participants, dates, location, and demographics when available) were recorded. Analyses were performed in Excel to characterize trends in participant diversity by company, study phase, study location, and time period.
Participant sex, which was generally reported to clinicaltrials.gov, suggests that male participants are over-recruited by 34%. Race-specific data was unreported for 65% of studies, and, when reported, suboptimal. Geographic diversity was lacking, as a majority (75%) of study sites were in the United States.
ATAC recommends that industry: Enroll more cisgender and transgender women, ensuring women participants are representative of the global and local HIV epidemics in race, ethnicity, and age; Enroll participants that reflect the racial and ethnic diversity of PLWHIV – including Black, Hispanic/Latinx, and Native American participants in the United States; Disaggregate data by sex, gender, race, ethnicity, and age. Disaggregate transgender women from MSM in reporting; Replace upper age limits with specific health related exclusion criteria; Prioritize enrollment of participants from impacted communities