Current Edition

Who Cares About Diversity in Clinical Trials?

The imperative to obtain a diverse body of clinical trial participants has been stressed in public statements for decades, including formal promotion by the U.S. National Institutes of Health (NIH), regulatory authorities such as the U.S. Food and Drug Administration (FDA), and recently, with the Consolidated Appropriations Act of 2023, even the U.S. Federal Government.1–4 Despite the duration and high profile of this issue, however, parties executing clinical trials, including sponsors, clinical research organisations (CROs), and academic centers, have remained insufficiently effective in addressing it. According to the 2020 U.S. Census, an estimated 33% of people in the U.S. identify as members of racial or ethnic groups that are underrepresented in medicine.5 However, between 1997 and 2014, only 4 to 5% of participants in trials of drugs submitted for approval by the FDA were from these groups.6 In 2017, nonHispanic Whites of European ancestry still comprised more than 90% of participants in clinical trials7 and even in 2020, the year during which the first Covid-19 vaccines were developed, and issues of racial diversity were prominent, 75% of clinical trial participants remained White.8 Although demographic variables other than race, such as gender, socioeconomic status, stage of disease, and residential location, are known also have critical impacts on medical outcomes and have also been mentioned in FDA Guidance, enrollment of diverse clinical research participants in these respects has received even less attention.

This state of affairs has persisted despite assertion by the vast majority of research professionals that DEI (Diversity, Equity, and Inclusion) is important. In the 2020 WCG Avoca Industry Survey, in which clinical research professionals were asked to provide confidential opinions about the importance of diversity among clinical trial participants, 81% of 215 respondents felt that at least one aspect of diversity (e.g., race, gender, socioeconomic) was important or critically important, including 40% who endorsed diversity as “critically important,” the extreme of the scale.9–10 This result was replicated in 2021 (75% and 37% of 101 respondents, respectively). 11 Similarly, in a survey conducted at a 2020 meeting of the Clinical & Translational Science Awards (CTSA) consortium leaders (funded by the NIH National Center for Advancing Translational Sciences), 94% of 231 respondents said they believed DEI in clinical and translational science to be “important,” and 86% were “committed” to making changes in CTSA processes to improve DEI.1 Clearly, there is a disconnect between what the vast majority of professionals voice to be important and the results their enterprises have actually achieved.

The present study seeks to gain insight into this disconnect by performing a detailed analysis of data regarding the DEI-related values and motivations of individuals executing clinical research projects. Herein we revisit the data from the 2021 WCG Avoca industry survey, asking specifically who cares (and does not care) about diversity in clinical research participation and why, rather than simply how many and how much. Our working hypotheses are1 that there may be systematic motivational differences across clinical research professionals that result in DEI-related decisions not being made in a manner that reflects the values of the wider group, and (2) that beliefs about why diversity is important (i.e., ethical vs scientific vs regulatory) may impact how critical to research quality diversity is felt to be. Although the authors fully recognise the challenges associated with enrolling diverse participants (and have discussed these at length elsewhere9–11), we believe that the values and motivations of acting parties – and not just forces beyond their control – play a role when it comes to making difficult decisions about practices that impact the DEI results achieved.