What question did this study set out to answer?

This research aims to evaluate how the type of Institutional Review Board (IRB) influences participant demographics in clinical trials between 2020 and 2024.

July 13, 2026

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Impact of Institutional Review Board Type and Food and Drug Administration Diversity Action Plan Draft Guidance on Demographics of Participants Enrolled Clinical Trials Conducted from 2020 to 2024

KWKersten WheelerUniversity of Jamestown AEAnn‐Margret ErvinJohns Hopkins University MEMarilisa ElrodChesapeake Public Schools

Key Points

This research aims to evaluate how the type of Institutional Review Board (IRB) influences participant demographics in clinical trials between 2020 and 2024.
Analyzed 211 phase 3 clinical trials registered on clinicaltrials.gov in the U.S.
Compared demographics of participants based on IRB type including commercial, academic, and medical center IRBs.
Assessed changes in demographics pre- and post-implementation of FDA Diversity Action Plan guidance.
Commercial and unknown IRBs had lower Black (10.4-12.1%) and Asian (3.1-3.8%) participation compared to Academic IRBs (Black: 13.7%, Asian: 9.4%, p < 0.01).
Medical Center IRBs reported the highest Hispanic enrollment (23.2%) versus commercial (16.8%) and other IRBs (18.3%).
Post-Diversity Action Plan implementation, demographic representation became more varied (p < 0.01).

Abstract

We assessed participant representation in phase 3 clinical trials registered on clinicaltrials.gov that were conducted in the U.S. between 2020 and 2024. From the 211 clinical trials analyzed, most relied on commercial IRBs (23.2%). Most of the trials in the “unknown” category were sponsored by pharmaceutical companies which likely relied on commercial IRBs. Trials relying on commercial and other/unknown IRBs had the least Black (10.4 −12.1%) and Asian (3.1–3.8%) participation as compared to Academic IRBs which had the highest Black (13.7%) and Asian (9.4%) enrollment (p < .01). Medical Center IRBs had the highest Hispanic enrollment (23.2%) compared to commercial (16.8%) and other IRBs (18.3%). When assessing the impact of the DAP, demographic composition was more varied after the DAP (p < .01). NIH and other sources of funding had greater overall participant representation, by ethnicity and race compared to industry funded trials (p < .01).

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Cite This Study

Wheeler et al. (Sat,) studied this question.

synapsesocial.com/papers/6a54807d475c38bf615a54ad https://doi.org/https://doi.org/10.1177/15562646261460666

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