As we close out 2024, TOTAL Diversity is honored to share insights from Dr. Jerome Adams, former U.S. Surgeon General and a steadfast advocate for public health and equity. In this exclusive interview, Dr. Adams reflects on how the evolving political environment is shaping clinical trials, particularly in terms of diversity and inclusion. His expertise and perspective are invaluable as we look ahead to the opportunities and challenges of 2025.
Reflections on the Past Year
2024 brought significant political and regulatory developments impacting diversity in clinical trials. Dr. Adams highlighted two major factors: the presidential election and the FDA’s delayed action on finalizing diversity guidance.
“The return of Donald Trump to the presidency has introduced uncertainty regarding diversity, equity, and inclusion initiatives,” said Dr. Adams. “While many efforts may face significant changes or halts, there remains an underlying recognition of the value of diversity in clinical trials.”
On the regulatory front, the FDA’s lack of finalized guidance for diversity action plans has left stakeholders in a “wait and see” mode. However, Dr. Adams emphasized that progress has been made in terms of awareness and commitment across the industry.
The New Political Landscape
With the changing political climate, Dr. Adams anticipates recalibration within companies regarding how they approach diversity.
“Many organizations have hired experts and recognized the importance of diversity,” he explained. “The challenge lies in moving forward without clear and enforceable guidance. However, the knowledge base and momentum built over the last several years provide a strong foundation.”
He underscored the critical need for industry players to maintain focus and commitment despite the uncertainties introduced by the political shift.
Challenges and Opportunities
When asked about potential challenges, Dr. Adams pointed to the lack of accountability and enforcement as significant barriers. However, he was optimistic about opportunities arising from increased scrutiny on the return on investment (ROI) for diverse populations and advancements in precision medicine.
“Precision medicine depends on diverse participation to develop effective treatments for different populations,” he noted. “This represents an opportunity to frame diversity as a critical component of quality and better outcomes rather than a checkbox for regulatory compliance.”
Building Trust and Awareness
Dr. Adams highlighted trust-building as essential to increasing participation in clinical research among historically marginalized communities.
“Participation in clinical trials offers benefits beyond the research itself—like comprehensive health assessments and early diagnoses,” he explained. “Framing diversity through the lens of improved individual health and better community outcomes can foster trust and engagement.”
Collaboration Across Sectors
Drawing on his experience as U.S. Surgeon General, Dr. Adams emphasized the power of collaboration:
“People need to know that you care before they care what you know,” he said. “Sponsors, investigators, and sites must build genuine relationships with communities, showing commitment beyond the trials themselves.”
A Vision for the Future
Looking ahead to 2025, Dr. Adams envisions a clinical trial ecosystem where safety and efficacy are prioritized for all populations, particularly those most at risk.
“Organizations like TOTAL Diversity play a crucial role in advocating for and demonstrating the feasibility of diverse clinical trials,” he said. “From the Diversity Site Assessment Tool to convening stakeholders, TOTAL has shown that representation is not only possible but essential for better outcomes.”
He encouraged continued advocacy and collaboration to sustain the momentum generated in recent years, emphasizing the need for framing diversity as a quality-driven imperative.
Closing Remarks
As we prepare for the challenges and opportunities of 2025, Dr. Adams left readers with a call to action:
“Let’s continue to build on the momentum created by the FDA, TOTAL Diversity, and other advocates. By creating meaningful relationships and demonstrating the value of diversity, we can advance clinical trials to better serve all communities.”
TOTAL Diversity extends its gratitude to Dr. Adams for his insights and unwavering commitment to equity. Together, let’s continue striving for a more inclusive clinical trial ecosystem in the year ahead.
