Launching Meaningful Change in Diversity, Equity, and Inclusion in Clinical Trials: Key Takeaways from the Diversity Site Solutions Summit ( Part 1 )

By Diana Foster, Ph.D., Vice President, Diversity, Equity, and Inclusion, Society for Clinical Research Sites

Clinical research is a transformative avenue for addressing inequities in healthcare. The recent Diversity Site Solutions Summit, hosted by the Society for Clinical Research Sites, spotlighted the life science industry’s potential to ignite meaningful change.  This first-of-a-kind summit focused on research site needs related to recruiting, engaging, and retaining diverse patient populations.

The keynote session of this important conference highlighted lessons learned with diverse enrollment throughout the COVID-19 pandemic. Panelists included two distinguished leaders in the field:

• Vice Admiral Jerome Adams, MD, MPH, is Total Diversity’s Chairman of the Board. As former 20th U.S. Surgeon General and member of the President’s COVID-19 task force, Dr. Adams was at the forefront of America’s most pressing health challenges, including increasing diversity in clinical trials. Dr. Adams is also Executive Director of Health Equity Initiatives at Purdue University.
• Lorena Kuri, MS, is Head of Diversity Strategy at Bristol Myers Squibb. Ms. Kuri begun her work in the pharmaceutical industry more than 15 years ago and has deep experience in Latin America and Canada. She is a board member for Women of Color in Pharma and an ambassador for the Red Shoe Movement, a women’s career development initiative.
• The session was facilitated by Dr. Diana Foster, Vice President, Diversity, Equity, and Inclusion for the Society of Clinical Research Sites.  She is the author of the Diversity Site Assessment Tool (DSAT) and author and frequent speaker related to her expertise in site specific topics on diversity and inclusion in clinical trials.

Key Takeaways from the Fireside Chat

The most significant takeaway from the fireside chat could be summed up as, when it comes to clinical trials, the need for diversity couldn’t be more urgent. 

Ms. Kuri states that patients in Brazil and Mexico lack access to drugs being developed by American sponsors and researchers. As one example, it took six years to get approval for a first-in-class inhibitor for a specific cancer in Brazil.  By that time, the United States already had the second generations of these drugs launched, approved, and reimbursed. She asked us to imagine how many lives could have been impacted in Latin America if that process had been accelerated.

In a related vein, Dr. Adams highlighted the disparities in asthma studies and asthma medication treatment between White children and children of color. Born in 1974, Dr. Adams had severe asthma while he was growing up.

It wasn’t until 2019 that a study found differences in the way Black children and White children respond to different asthma medications. Black boys are twice as likely to die of asthma than White boys, yet Black boys constitute only five percent of participants in clinical research trials.

In another example Dr. Adams cited was in reference to his personal use of blood pressure medication, which often affects Black patients and White patients differently, requiring different treatments for each. Dr. Adams, as Surgeon General of the United States, personally had to fight to get the right blood pressure medications for his own condition. Underrepresentation of minorities in clinical trials has, no doubt, contributed to this ongoing disparity in care.

Lessons Learned from Operation Warp Speed

When the COVID-19 pandemic hit, low minority enrollment in clinical trials had been a reality for many years. This crisis confronted us with major deficits in our knowledge base about the ways different groups of people respond to treatments and medications.

Operation Warp Speed was born of the need to move very quickly in developing and approving vaccines for the population at large. COVID inadvertently provided us with a laboratory within which to learn about the best ways to improve diversity in clinical trials.

Key Points of Learning Included:

1. There is a need to understand and address a historical lack of trust in government and medical institutions.
2. It may be more effective to increase enrollment at sites that already have highly diverse enrollment than to focus our efforts on low diversity sites.
3. Having the right people at the site, with the right understanding and passion, is key.
4. The assumption that ideal location means diverse enrollment may not be accurate. 
5. Sites must be provided education and support so that they understand what it takes to engage minority populations more fully.
6. All these methods will only work if we also ensure the protocols are inclusive by design. 

In part two of this fireside chat summary, these points will be expanded.  In addition, discussion will focus on the FDA draft guidance on diversity in clinical trials, along with best practices in community engagement, accountability, and self-assessment.

Diana Foster, PhD, is CEO of TOTAL Diversity, a full-service CRO and Diversity Organization with an integrated focus on support services highlighting diversity and inclusion in clinical trials. Dr. Foster also serves as Vice President of Diversity, Equity and Inclusion for the Society for Clinical Research Sites.