Is There Progress Amidst the Swinging Diversity Pendulum?

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Depending on who you ask, opinions on the state of diversity, equity, and inclusion in drug development today vary widely. With news headlines such as “Is DEI Officially Dead” and “Are Companies Quiet Quitting DEI?”^1,2 and the overturn of affirmative action in higher education by the United States Supreme Court, a recently buzz-worthy and waxing movement to incorporate inclusion and achieve proportional representation in clinical trials and in the workplace, is now waning.

For diversity, equity, and inclusion (DEI) scholars and professionals who have been involved in drug development for decades, the swinging of the diversity pendulum is nothing new. Attention and fervor for DEI initiatives swing back and forth.³ But this time, regulatory requirement for Diversity Action Plans, widespread interest in ensuring access to clinical trials among underserved communities, and new evidence-based insights on DEI practices and their impact, may finally sustain DEI momentum.

Pockets of momentum

Despite sensationalized headlines and heated discourse about the merit and value proposition of DEI initiatives, efforts to improve access and inclusion will move forward in 2025 in select ways. At the national-level, funding to study racial disparities has not dissipated. The National Institute on Minority Health and Health Disparities at the National Institute of Health, for example, has continued to see healthy funding in 2023 and 2024 for research on improving health disparities among marginalized communities. Momentum will also come from the FDA’s June 2024 draft guidance requiring pharmaceutical companies to disclose strategies and tactics that they plan to implement to address enrollment and retention of racial minority participants in their studies.⁴

Aside from regulatory pressure, the commitment among drug development sponsors to continue investment in DEI in 2025 is less clear. Although there is widespread agreement that achieving enrollment diversity is critically important in principle, many sponsor companies have diverted investment in DEI initiatives in the face of a difficult global economic environment and intensifying drug development operating pressures. A bell-weather measure of this commitment and investment is the presence of a Chief Diversity Officer (CDO) overseeing DEI initiatives across the development organization. Recent research by the Tufts Center for the Study of Drug Development (Tufts CSDD) shows that the CDO role is on the decline as the diversity pendulum reverses its swing.

Tufts CSDD conducted a review of the top pharmaceutical companies (based on annual revenue). Twenty-one were identified with dedicated CDOs whose sole responsibility was to oversee and direct the organization’s DEI efforts. CDOs who had hybrid titles or shared responsibilities with other Human Relation functions were not included in this analysis.

Of the 21 companies identified, 57% had a dedicated CDO as of Aug 2024 and four-out-of-ten (42%) of these sponsor companies are headquartered in the US. Among the companies that did not have a current CDO, 22% formerly had a dedicated CDO who transitioned out of the role, either to leave the organization or accept a different role within the organization. Once vacated, the CDO role was not filled or renewed.

Most (72%) CDOs are women; 64% are Black or African American, followed by 27% who are White women. Less than half (45%) of CDOs were internally hired leaders who had, on average, 15 years of experience within the organization. The other half (54%), of CDOs were external hires, all of whom were DEI executives with cross industry experience.

Tufts CSDD also examined the origins of the CDO role, largely by reviewing the time when the individual was hired and whether they were the first to assume the CDO role in that company. Seven out of the 21 companies had a dedicated CDO prior to 2020, with some creating the role as early as 2001. In 2020, demand for DEI leadership grew with “Chief Diversity Officer” across economic sectors being one of the fastest growing roles in 2020 and 2021, peaking in 2023.⁵ Growth in demand for CDOs in 2020 no doubt coincided with the Black Lives Matter movement ignited by the mass social unrest that unfolded in the wake of the wrongful death of George Floyd. Among companies that created a CDO role as a reactionary response in 2020, 50% saw the role disappear or become merged with another HR function at the time of writing this article.

Evidence and impact

It is unfortunate timing to see the diversity pendulum swing with the decline of the dedicated CDO role. Still, during the past four years much progress has been made in our understanding of factors associated with demographic under-representation in clinical trials and poor enrollment diversity. Empirical studies conducted by Tufts CSDD have identified demographic and socioeconomic factors associated with patient willingness to participate in clinical trials and demonstrated a significant relationship between investigative site personnel diversity and target enrollment diversity. Recent Tufts CSDD studies have shown that virtual and remote options offered in clinical trials—based on patient preferences—are significantly correlated with improvements in enrollment diversity.

A recent Tufts CSDD study found early indications that long-standing disparities among Black participants enrolled in clinical trials are beginning to improve. Evaluating the demographics of patients enrolled in pivotal trials supporting all drug and biologic approvals since 2007, the over-representation of white participants and the under-representation of Black participants between 2017 and 2021 decreased significantly. No improvements were observed among other racial or ethnic groups.⁶ And a 2024 Tufts CSDD found that the use of artificial intelligence and machine learning by sponsors and CROs to identify diverse patient populations in clinical trials yielded on average a 68% time savings over traditional study planning and initiation activities.

Closing

In the absence of dedicated roles and functions focusing on DEI, will we see the application of these insights and more improvement in proportional representation? There is sufficient insight from empirical studies conducted during the past four years to inform the value proposition of ongoing investment, and the implementation of practices, intended to improve enrollment diversity.

Drug development optimization requires doing what is right while meeting scientific and operating objectives. Achieving proportional representation in clinical trials is not a Sisyphean task.

Jennifer Kim and Kenneth Getz, Tufts CSDD

References

1. Asare JG. Is DEI Officially Dead? Forbes. Accessed September 2, 2024. https://www.forbes.com/sites/janicegassam/2023/07/16/is-diversity-equity-and-inclusion-officially-dead/

2. Kratz J. Are Companies Quiet Quitting DEI? Forbes. Accessed September 2, 2024. https://www.forbes.com/sites/juliekratz/2024/03/05/are-companies-quiet-quitting-dei/

3. Department of Labor. History of DE&I. Office of Labor-Management Standards. December 15, 2023. Accessed September 2, 2024. https://www.dol.gov/agencies/olms/deia/history

4. Food and Drug Administration. Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry. Published online 2024. Accessed July 18, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies

5. Anders G. Who’s vaulting into the C-suite? Trends changed fast in 2022. Linkedin. February 2, 2023. https://www.linkedin.com/pulse/whos-vaulting-c-suite-trends-changed-fast-2022-george-anders/?trackingId=jOiiEvmfQI6sMbG%2BKwpCIQ%3D%3D

6. Smith Z, Botto E, Johnson O, Rudo T, Getz K. New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics. Ther Innov Regul Sci. 2024;58(1):143-152. doi:10.1007/s43441-023-00579-1