Who Cares About Clinical Trial Diversity? Researchers Have Some Ideas

The current lack of diversity among clinical trial participants could bias research findings, limit the generalizability of results, and exacerbate health disparities.^1,2,3,4 This remains a serious challenge despite decades of advocacy for diversity, equity, and inclusion (DEI).

So why doesn’t execution align with aspiration? The annual WCG Avoca Industry Survey sheds light on this disparity.⁵ The respondents represented Sponsor and Provider companies, as well as academic research organizations.

Researchers focused on two key items in the survey:

• Rate the importance of diversity to clinical research quality on a scale of 1 to 5.
• Indicate whether these ratings were driven primarily by scientific, regulatory, ethical, or marketing and sales considerations.

The findings offer insights not only into why DEI initiatives stall, but what the industry can do to better promote diverse clinical trials.

Resistance From the Old Guard

The research found an inverse correlation between how long someone had been in their role and the importance they assigned to diversity. Respondents who had been in their position for less than 10 years rated the importance of diversity higher than those with more than 10 years in their role. This relationship remained consistent, even when factoring in age, company tenure, functional area, and location.

One explanation for this trend may be that individuals who have worked longer in their roles may be more entrenched in the status quo and see DEI programs as costly, disruptive, and nonessential. These more senior staffers may be more likely to hold budgetary, timeline, and regulatory responsibilities, and their beliefs about what is critical carry substantial weight. Their skepticism or reluctance can undermine or delay DEI efforts.

Science Drives Change

Another interesting finding from the study relates to why people support DEI. Respondents who saw the pursuit of diversity as a scientific or ethical imperative felt more strongly about its importance than did those who considered diversity important primarily for regulatory or marketing reasons.

This suggests that efforts to advance diversity should explore what motivates individuals, especially those in senior roles who wield decision-making authority.

Engage and Educate

The study highlights the necessity of engaging in discussions with upper-level staff to better understand their perspectives. By educating clinical trial professionals on the scientific and ethical reasons for diversity, and by appointing leaders who recognize and support these reasons, we may see more decisions supporting diversity. Engaging senior staff in conversations and understanding their viewpoints can assist in crafting more effective policies and programs that promote diversity in clinical trials.

Looking Ahead

The study underscores important themes that may be at work in the lack of diversity in clinical trial participation, including cultural difficulties, structural restrictions, and disincentives for change. More research and analysis are needed, but these findings can nevertheless help sponsors, sites, and other stakeholders make decisions that will improve the quality and inclusivity of clinical research.

The onus is on us as an industry. We fully recognize the challenges associated with enrolling diverse participants, but 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.

Take action on DEI initiatives and schedule a consultation with our experts today.

---

References:

1. Bibbins-Domingo K, Helman A. (eds.) Why Diverse Representation in Clinical Research Matters and the Current State of Representation within the Clinical Research Ecosystem. National Academies Press (US); 2022. https://www.ncbi.nlm.nih.gov/books/NBK584396/
2. FDA guidance “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry” – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial. November 2020
3. Clark LT, Watkins L, Piña IL, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Current Problems in Cardiology. 2019;44(5):148-172. doi:https://doi.org/10.1016/j.cpcardiol.2018.11.002
4. Gross AS, Harry AC, Clifton CS, Della Pasqua O. Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response. Br J Clin Pharmacol. 2022;88(6):2700-2717. doi:10.1111/bcp.15242
5. 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/