Could Lives Be Endangered by Cutting DEI?

Over the past several days, the U.S. Food and Drug Administration has quietly taken down its guidance detailing Diversity Action Plans for clinical trials, which were set up to evaluate drugs, devices and other medical-specific products.

Importance of Diversity in Clinical Trials

To improve the results across a wider cross section of patient groups that have been historically excluded from these trials.

Lack Of Representation Has A Financial And Social Cost

Lack of representation in trials has long had high financial and social costs. Ensuring that patients have a longer life expectancy, a disability-free life, and increased number of years in the labor force translates to an additional hundreds of billions of dollars infused into the U.S. economy over the next three decades. Conversely, poor outcomes are a tremendous drain on both the economy and the healthcare system overall. If better representation in clinical trials reduces health disparities by even a modest amount, the analysis found that achieving diverse representation in research would be worth billions of dollars in savings to the United States.

Impact on Oncology and Other Fields

For example, Black women are three times more likely to die from a pregnancy-related cause than white women and pain is assessed differently by physicians in Black versus white patients. It is the ongoing policies within the medical industry often rooted in historically biases practices and access to resources determined by race and ethnicity that build up this disparity. The result was the FDA’s priority to address this.

Is The Time Now To Lean On Pharma Companies?

While the FDA is being directed to address diversity in clinical trials, one solution to the inclusion gap may lie in pharmaceutical companies investing in more inclusive practices in this area.

A Call to Action for Pharma Companies

In the last several years, clinical trial initiatives have become a growing focus for pharma giants. Companies such as Amgen, Merck & Co., Eli Lilly and GSK have recently begun new efforts to boost diversity in trials.

I contacted Batool Kazmi, PhD, and Sabrina Modellas of Hero Collective Health—a healthcare communication agency that helps pharmaceutical companies with inclusive clinical trials, recruitment and communications—to discuss this topic.

Conclusion

By continuing to evangelize the tangible benefits of diversity in clinical trials—such as improved recruitment efficiencies, meeting enrollment goals and launching trials more effectively—pharma can demonstrate that inclusivity isn’t just ethical; it’s also critical for operational success and advancing health equity.

FAQs

Q: Why is diversity in clinical trials important?

A: Diversity in clinical trials is important to improve the results across a wider cross section of patient groups that have been historically excluded from these trials.

Q: What is the impact of lack of representation in clinical trials?

A: Lack of representation in trials has long had high financial and social costs. It also perpetuates health disparities, denying marginalized groups access to innovative therapies and leaving them with less effective care.

Q: Can pharmaceutical companies take the lead in promoting diversity in clinical trials?

A: Yes, pharmaceutical companies have the power to step up where the FDA has stepped back. They can leverage key community partnerships to build trust and access, set and publicize measurable goals for inclusive enrollment and practices, and form industry coalitions to share best practices for achieving inclusive trial objectives.

Q: What are the benefits of inclusive clinical trials?

A: Inclusive clinical trials can lead to improved recruitment efficiencies, meeting enrollment goals and launching trials more effectively, and ultimately, achieving better health outcomes for all populations.