Are Clinical Trial Diversity Initiatives at Risk of Being Dismantled?

Prior to the COVID-19 pandemic, semi-structured qualitative interviews with research site staff revealed that public policy and pharmaceutical sponsor expectations had minimal influence on efforts to prioritize inclusive recruitment.¹

2020 marked an inflection point. Although clinical trial diversity has been a long-standing issue and topic of discussion for decades, the COVID crisis brought persistent disparities in health outcomes to the forefront.² Racially and ethnically diverse communities were disproportionately impacted by the virus, exposing broader issues of social injustice and racial inequality beyond the healthcare system.³ Following the deaths of Breonna Taylor, George Floyd, and many others in the spring of 2020, numerous large pharmaceutical companies issued public statements reaffirming their commitment to diversity, equity, and inclusion (DEI) as a societal imperative. These statements were accompanied by multimillion-dollar pledges to address systemic inequities within both their communities and workplaces.⁴

This period also marked a shift toward a heightened focus on fostering inclusive cultures and integrating DEI within organizations. Many companies implemented organization-wide inclusion training, set goals to increase workforce diversity, and expanded employee resource groups. By 2023, nearly 88% of Pharmaceutical Research and Manufacturers of America (PhRMA) member companies reported collaborating with external partners to build a diverse talent pipeline.⁵ By 2025, approximately three-quarters of pharma companies (78%) reportedly had DEI initiatives integrated into their corporate strategies, with 72% including them as part of their formal corporate goals.⁶

Since 2020, drug manufacturers have also increasingly integrated DEI into their trial strategies, marking a shift from reactive to proactive planning. These efforts span patient-centric trial design, investigator development, community engagement, operational planning, and performance tracking.⁵ Notable examples include:

• Genentech launched a Site Alliance that enrolls Black and Hispanic/Latinx patients at reportedly twice the rate of other sites within the same studies.⁷
• GSK met its 2023 goal of submitting diversity action plans to the FDA for all Phase III trials.⁸
• Bristol Myers Squibb exceeded goals to conduct trials in racially and ethnically diverse metropolitan areas of the US.⁹
• Johnson & Johnson used AI and geospatial analysis to raise Black participation to 10% in five multiple myeloma studies.¹⁰
• Sanofi committed $18 million in 2024 to three historically Black medical schools to hire clinical research staff and enhance clinical trial infrastructure.¹¹

In January 2021, a survey of 31 out of 33 PhRMA member companies was conducted to assess strategies pursued to improve diversity in clinical trial participation.¹² At the time, all respondents had either implemented or were planning to implement measures to improve trial access and consider the needs of diverse populations in trial design. Key findings included:¹²

• 97% had already initiated access-focused measures such as remote data collection and coverage of transportation costs.
• 71% were actively pursuing patient-centric trial design approaches, and 29% were in the process of implementing such initiatives.
• 45% reported efforts to broaden eligibility criteria, where scientifically and clinically appropriate, to enhance enrollment diversity.
• 58% were using real-time enrollment data to proactively identify and address diversity gaps

Fast forward to 2025. Following the current administration’s efforts to ban all DEI and gender identity initiatives,^13-15 opposition groups such as the National Center for Public Policy Research and the National Legal and Policy Center challenged corporate DEI programs.^16,17 These groups submitted shareholder proposals during the 2025 annual meetings of several major companies, calling for the elimination of DEI-related policies and initiatives.^16-19 However, shareholders at major pharmaceutical companies—including BMS, Gilead, Merck, and Pfizer—overwhelmingly rejected these proposals.^18,19

Merck’s CEO responded by reaffirming the company’s commitment to diversity and inclusion: “It is at the core of who we are, our values, and how we operate as a company. It is also a strategic imperative.”¹⁷ Echoing this sentiment and emphasizing the connection between workforce and clinical trial diversity, the BMS board of directors noted that a diverse workforce helps expand the company's patient population by driving strategies to deliver greater access to varied clinical trial patients across geographic regions.²⁰

In February 2025, four large pharmaceutical companies publicly reaffirmed their commitment to advancing clinical trial diversity, underscoring that this work remains central to their values and ongoing.²¹

Despite this positive momentum, some caution appears evident. Several companies have subtly adjusted their public positioning—revising annual and impact reports, as well as corporate websites, to reframe messaging related to diversity goals. For example, one large pharma company shifted sexual orientation and gender identity data collection and gender-diverse investigator goals to internal metrics.²² Multiple pharma companies removed aspirational workforce representation goals as well as eliminated DEI mentions from their 2024 reports.^21-24

So where does this leave the industry?

Applied Clinical Trials recently conducted its “State of the Industry” survey. In feedback from questions focused around DEI, many clinical operations professionals (54%) reported being very or moderately concerned about potential policy rollbacks affecting their organization’s ability to meet diversity goals (see Figure 1 below). While 27% believed such changes could reverse progress, another 27% felt that although current strategies may need to shift, their organizations remain committed.

Still, maturity levels vary. When asked about DEI-related trial design practices (see Figure 2 below):

• Only 24% of respondents reported benchmarking disease demographics against enrolled populations.
• Although 49% recently implemented elements to reduce the burden of travel to study visits, fewer (27%) had revised eligibility criteria to be more inclusive.

When asked about operational challenges in advancing DEI in clinical trials (see Figure 3 below), respondents most frequently cited participant burden and access issues (29%). Yet only half had reported actively addressing these barriers.

Nearly 20% said DEI is not considered a trial design priority at their organization. This may be partially explained by the respondent type—e.g., site-based organizations not responsible for trial design and dependent on sponsors for recruitment materials. However, it may also reflect a general lack of DEI adoption in certain organizations.

Compared to the 2021 PhRMA member survey,¹² these findings suggest that while DEI has gained traction industry-wide, it may not be as mature outside of the larger PhRMA member companies. Smaller companies may lack the infrastructure or resources to develop robust DEI strategies—something that may soon be required through diversity action plans. These companies may benefit from publicly available resources, such as the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard guidance documents, toolkits, and peer-shared best practices.^25,26

Encouragingly, funding and resource constraints were a challenge for just 15% of respondents of the Applied Clinical Trials survey—marking progress from earlier years when implementing diversity goals at the trial level was believed to increase study timelines and costs.

Still, there is work to be done. According to 2025 industry data, just 14% of clinical trial protocols explicitly include DEI considerations.⁶ Research published in The Lancet found only modest improvements over time in US trial diversity, with racially and ethnically diverse populations remaining underrepresented relative to their share of the US population.²⁷

Regulatory uncertainty is a cause of concern among clinical research stakeholders (17%). While industry momentum is growing, ongoing political shifts and structural barriers suggest DEI in clinical research remains fragile. Although DEI programs have not been dismantled, signs of regression are evident.

Although DEI remains a core tenet in pharma, strategies and goals have been reframed to align with the evolving political climate. We can only hope this is merely a change of terminology and not a threat to true representation and inclusion.

Rebecca Johnson, PhD, is a clinical research recruitment and inclusion executive and strategist. In her most recent role, Johnson led the clinical trial recruitment and diversity, equity, and inclusion functions at SPARC. Prior to that, she held several leadership positions within IQVIA’s patient recruitment team, including advising pharmaceutical sponsor teams with their efforts to achieve more diverse trial populations. Johnson has a master’s in public health and a PhD in health sciences. Her doctoral dissertation research focused on increasing access to clinical trials for historically underrepresented populations.

References

1. Johnson, R. (2020). Understanding elements involved in active racial and ethnic minority recruitment practices for biopharmaceutical-sponsored clinical trials: A socio-ecological qualitative inquiry (Publication No. 27959320) [Doctoral dissertation, Seton Hall University]. ProQuest Dissertations & Theses Global.

2. Artiga, S., Corallo, B., & Pham, O. (2020, August 17). Racial disparities in COVID-19: key findings from available data and analysis. Kaiser Family Foundation. https://www.kff.org/racial-equity-and-health-policy/racial-disparities-covid-19-key-findings-available-data-analysis/

3. Best, A., Fletcher, F., Kadona, M., & Warren, R. (2021). Institutional distrust among African Americans and building trustworthiness in the COVID-19 response: Implications for ethical public health practice. Journal of Health Care for the Poor and Underserved, 32(1), 90-98.

4. Upton, J. (2021, July 1). Building belonging: Pharma’s new focus in DE&I. Pharmaceutical Executive, 41(7).https://www.pharmexec.com/view/building-belonging-pharmas-new-focus-in-dei

5. PhRMA. (2024, April 8). The biopharmaceutical industry: A sustained commitment to advancing diversity, equity, and inclusion. https://www.phrma.org/resources/a-sustained-commitment-to-advancing-diversity-equity-and-inclusion

6. Eser, A. (2025, May 30). Diversity, equity and inclusion in the pharma industry statistics. ZipDo. https://zipdo.co/diversity-equity-and-inclusion-in-the-pharma-industry-statistics/

7. Incorvaia, D. (2024, August 5). 3 years in, Genentech’s Site Alliance enrolls underrepresented patients 2 times faster than other sites. Fierce Biotech. https://www.fiercebiotech.com/cro/three-years-site-alliance-genentech-shares-progress-improving-clinical-trial-diversity

8. Floersh, H. (2024, May 22). ‘We’re trying to do the right thing.’ GSK sets diversity targets, partners with DEI firm to educate trial staff. Fierce Biotech. https://www.fiercebiotech.com/cro/gsk-sets-diversity-targets-partners-dei-firm-trial-staff-education

9. Bristol Myers Squibb Company (2024, August 1). Diversity in clinical trials is a scientific imperative. https://www.bms.com/media/media-library/scientific-media-resources/importance-of-clinical-trials-and-role-of-diversity.html

10. Dubin, C. (2024, May). Has pharma done enough to transform clinical trial diversity?AAPS Newsmagazine.https://www.aapsnewsmagazine.org/aapsnewsmagazine/articles/new-page2/may24/aaps-news-may24

11. Sanofi (2024, October 16). Sanofi commits $18 million to Howard University College of Medicine, Meharry Medical College, and Morehouse School of Medicine to increase diversity in clinical studies. Sanofi US News. https://www.news.sanofi.us/2024-10-16-Sanofi-commits-18-million-to-Howard-University-College-of-Medicine,-Meharry-Medical-College,-and-Morehouse-School-of-Medicine-to-increase-diversity-in-clinical-studies

12. PhRMA. (2022, July). Industry efforts to enhance clinical trial diversity. https://www.phrma.org/resources/a-look-at-company-efforts-to-enhance-clinical-trial-diversity

13. Exec. Order No. 14173, 3 C.F.R. 8633-8636 (2025). https://www.govinfo.gov/content/pkg/FR-2025-01-31/pdf/2025-02097.pdf

14. Exec. Order No. 14151, 3 C.F.R. 8339-8341 (2025). https://www.govinfo.gov/content/pkg/FR-2025-01-29/pdf/2025-01953.pdf

15. Exec. Order No. 14168, 3 C.F.R. 8615-8618 (2025). https://www.govinfo.gov/content/pkg/FR-2025-01-30/pdf/2025-02090.pdf

16. National Center for Public Policy Research. (2025, May 6). National Center proposals take center stage at Bristol Myers Squibb Meeting. [Press Release] https://nationalcenter.org/ncppr/2025/05/06/national-center-proposals-take-center-stage-at-bristol-myers-squibb-meeting/

17. Armstrong, A. (2025, May 30). Merck CEO calls diversity ‘core’ to operations as anti-DEI measure is defeated. BioSpace. https://www.biospace.com/business/merck-ceo-calls-diversity-core-to-operations-as-anti-dei-measure-is-defeated

18. BristolMyers Squibb Company (2025). 2025 annual meeting of shareholders.https://www.bms.com/investors/shareholder-services/annual-meeting-of-shareholders.html

19. Impactivize (2025). 2025 anti-DEI proposals and shareholder voting results. https://www.impactivize.org/2025-shareholder-proposals/

20. Bristol Myers Squibb (2025, March 26). 2025 annual meeting of shareholders. [Proxy Statement]https://www.bms.com/assets/bms-ar/documents/2024/bms-2025-definitive-proxy-statement.pdf

21. Incorvaia, D. (2025, February 27). As Trump targets DEI practices, 4 pharmas reaffirm commitment to diversifying clinical trials. Fierce Biotech. https://www.fiercebiotech.com/cro/trump-targets-dei-4-pharmas-reaffirm-commitments-diversifying-clinical-trials

22. Bristol-Myers Squibb Company. (2024). 2024 building a better future report. [Impact Report] https://www.esg.bms.com/assets/bms-esg/us/documents/BMS-Building-a-Better-Future-Report-2024.pdf

23. GSK. (2024). GSK Responsible Business Performance Report 2024. https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf

24. Garde, D. (2025, February 12). Drugmakers step back from diversity pledges in vow to Trump.Bloomberg. https://www.bloomberg.com/news/articles/2025-02-13/bristol-removes-dei-pledges-from-its-latest-annual-report

25. The MRCT Center of Brigham and Women’s Hospital and Harvard. (2024). Representation in research. The MRCT Center of Brigham and Women’s Hospital and Harvard.https://dev.mrctcenter.org/project/representation-in-research/

26. Fashoyin-Aje, L., Tendler, C., Lavery, B., Ghiorghiu, S., Gerald, B., Kalidas, C., Richie, N., Winson, K., Warren, N., Tellman, T., Retzlaff, J., Fofi, M., & Pazdur, R. (2023 September 15). Driving diversity and inclusion in cancer development – industry and regulatory perspectives, current practices, opportunities, and challenges. Clinical Cancer Research, 29(18), 3566-3572.

27. Turner, B., Steinberg, J., Weeks, B., Rodriguez, F., & Cullen, M. (2022 July). Race/ethnicity reporting and representation in US clinical trials: A cohort study. The Lancet Regional Health - Americas, 11: 100252.