Representation Matters: To Achieve Clinical Trial Diversity, Sites and Sponsors Must Look Inward

Why are clinical trials failing to reach their participant diversity goals? One reason could be a lack of employee diversity among sites and sponsors.

The annual WCG Avoca Industry Survey explored various factors contributing to the lack of diversity in clinical research.¹ Among the findings: The longer site and sponsor employees have been in their roles, the less importance they tend to assign to diversity.

One implication of this finding could be that a lack of staff diversity affects DEI-related decisions. Diversity of research staff is known to be highly associated with diversity of trial participants, and conceivably, respondents who had spent less time in their roles and at their companies may themselves have been more diverse.

It follows, then, that lack of diversity among those who design, conduct, and oversee trials contributes to a lack of diversity among clinical trial participants. Without diversity in decision-making roles, an “old school” mentality may hamper efforts to increase diversity in clinical trials.

A growing body of evidence supports this association.

The Link Between Participant and Staff Diversity

The Tufts Center for the Study of Drug Development found that clinical trial sites with higher racial and ethnic diversity among staff members had greater diversity among trial participants. Moreover, sites with higher levels of staff diversity were also more likely to report that they considered diversity critical to their success and to have implemented operating practices to encourage diversity.²

And yet, clinical trial professionals are not a diverse lot. Approximately one third of people in the United States identify as members of racial or ethnic groups that are underrepresented in medicine, according to the 2020 Census, yet:

• less than 6% of research faculty are members of these groups,³ and

• fewer than 10% of principal investigators are black.⁴

As the authors of a NEJM Perspective piece write, “We have seen little in the way of racial or ethnic diversification of research leaders, trainees, or trial participants.”⁵

Moving Forward: A Strategy, not a Program

A multicultural team brings valuable cultural insights and competency. They are better equipped to navigate language barriers, cultural beliefs, and practices that could influence patient participation and adherence to trial protocols.

Sites, sponsors, and CROs must recognize that diversity is not a box to check off a list; it is a strategy. For example, identifying and supporting community sites and physicians who may not have previously participated in clinical research can go a long way to bolstering participant diversity, as well as understanding the voice of diverse patients when designing and developing clinical trial protocols.

Do you want to create a successful Diversity, Equity, & Inclusion strategy in your organization? We can help. Schedule a consultation with one of our DEI experts today.

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References:

1. Calaprice, D., et al. Who Cares About Diversity in Clinical Trials? – Journal for Clinical Studies. March 29, 2023. https://journalforclinicalstudies.com/who-cares-about-diversity-in-clinical-trials/
2. Tufts Center for Study of Drug Development. Diversity of Site Staff Highly Associated with Diversity of Patients Enrolled in Trials. As summarized in TuftsNow Dec. 3, 2021 https://now.tufts.edu/2021/12/03/increase-diversity-clinical-trials-first-increase-staff-diversity
3. Boulware LE, Corbie G, Aguilar-Gaxiola S, et al. Combating Structural Inequities – Diversity, Equity, and Inclusion in Clinical and Translational Research. N Engl J Med. 2022;386(3):201-203. doi:10.1056/NEJMp2112233
4. Cramer G. A Conundrum of Trust: Addressing the Diversity Gap in Clinical Research. ACRP Clinical Researcher ACRP. Feb. 15, 2022. https://acrpnet.org/2022/02/15/a-conundrum-of-trust-addressing-the-diversity-gap-in-clinical-research/
5. Boulware LE. N Engl J Med. Op. cit