RACE AND ETHNICITY REPORTING AND REPRESENTATION IN US CONTRACEPTIVE CLINICAL TRIALS FROM 2007-2024

Abstract

Objectives

Contraceptive clinical trials inform policy and practice changes, yet participants are often non-representative of the US population. We aimed to characterize race and ethnicity reporting among completed contraceptive trials.

Methods

We queried ClinicalTrials.gov for all completed trials (2007–2024) with keywords “contraception” or “contraceptive.” We extracted all race and ethnicity participant data. If this was not reported, we manually reviewed linked publications. We categorized trials as “representative” or “non-representative” of the US population if the proportion of non-White participants were within 30% of the 2020 Census estimates. We described and compared trial characteristics for reporting and representation using chi-squared tests (IBM SPSS Version 29). The study included only publicly available data and was deemed exempt by the Colorado Multiple Institutional Review Board.

Results

We reviewed 129 trials meeting initial inclusion criteria; 55 were excluded for including non-US sites or the study was not related to contraception, leaving 74 for the final analysis. Most reported race or ethnicity (85.1%) and occurred in the West region (32.4%); 43.2% evaluated pharmacokinetics, safety, or efficacy. 68.9% were non-representative of the US population. Of those, 82.4% had overrepresentation of non-White participants. Trial phase, funder type, completion year, contraceptive method, and study type did not differ between “representative” and “non-representative” studies.

Conclusions

Race and ethnicity of participants in contraceptive trials are not representative of the US. Deliberate and thoughtful recruitment strategies are needed to ensure that contraceptive trials are diverse, inclusive, have adequate representation, and are not unintentionally over-recruiting populations with historical mistreatment within the research community.