Treatments for All: The Importance of Diversity in Clinical Trial Enrollment

By:  Scott Lerman, VP, Partnerships Lead

We start, as many stories do, with a personal anecdote.   

I love this photo. It’s of my grandmother and my father, taken at my Bar Mitzvah more than 40 years ago. Our family lore ultimately deemed this day my grandmother’s “last good day.” She passed away a little less than 2 years later, her fate sealed by the cruelty that is Alzheimer’s disease.  

Ever since, and throughout my career, I’ve been passionate about clinical research and patient engagement in general, but with a particular interest and soft spot for Alzheimer’s disease and related dementias. You could imagine my excitement upon the FDA approval of Leqembi®, the anticipated approval of Donanemab and the many other biopharmaceutical companies looking to offer hope to the millions of people living with Alzheimer’s disease (not to mention the millions more who care for and love them). 

Despite the tremendous hope that exists in the field, a consistent stark and persistent disparity in clinical research still exists. As outlined in a recent article in the Washington Post, only 2.6% of patients (about 5% at US trial sites) in the pivotal clinical trial for Leqembi were BIPOC, and similarly low for the Donanemab trials.  

It has been well established that the BIPOC population develops the disease and related dementias at twice the rate of their White counterparts but are less likely to receive specialized care and are diagnosed at later stages. As more potentially disease-modifying drugs come to market, this issue becomes even more exacerbated, especially since they must be used early to have an effect. 

One potential reason why clinical trial participation among African Americans has been so low in Alzheimer’s disease, as outlined by the Washington Post, is that Alzheimer’s research has long been centered in memory clinics at elite academic institutions. These memory clinics have served as effective recruiting grounds for trials that end up with a predominantly White enrollment. 

The good news is that government organizations have started to recognize these disparities and are attempting to address them. In 2022, the FDA issued guidelines for industry designed to bolster diversity in studies, while the National Institute on Aging recently pledged to prioritize funding requests that are “appropriately inclusive.” 

When we learned my grandmother had Alzheimer’s disease in the early 80s (because – remember – there were no formal diagnoses back then), there was nothing to do but wait for the inevitable. At Reverba, our approach to diverse patient recruitment in trials has also evolved, and we urge our clients to take several things into account when executing a strategy to reach these audiences: 

• UNDERSTAND the specific areas for focus within diversity, equity, inclusion and access –  depending on the disease state – it will likely not be a one size fits all approach. 

• RECOGNIZE patients and caregivers may provide perspectives in ways you aren’t used to. Utilizing a high-touch, culturally responsive approach, coupled with a deep understanding about the communities you’re looking to reach is vital to ensure you’re communicating appropriately. 

•  REALIZE you may need to build trust to achieve true participation. Showing up isn’t enough – you might need to connect with churches or mosque, large community centers or Greek letter organizations/societies that are within the community that already have the population but also have a solid infrastructure. Most importantly, don’t expect to change perceptions overnight. 

• RESPECT historical biases and ingrained beliefs in the BIPOC community. According to the Alzheimer’s Association nearly two-thirds of Black Americans (62%) believe that medical research is biased against people of color.  Also, 69% of Black Americans fear “being a guinea pig” and another 45%  are concerned about getting sick from treatment – far more than other racial groups.  

• BE OPEN to learn how to best partner with groups that may be very different from your teams.   You need to actively listen to a variety of populations and how they share their thoughts.  Being able to objectively listen will help the team to move forward productively with a variety of patient populations. 

We know that individuals living with chronic health conditions are more than just patients. They’re people. They have real lives, filled with to-do lists and jobs, challenges, successes and families they love.  We help create trusted spaces where people can bravely share their health journeys – starting a ripple effect that grows as others use their voice.  

Whether you want to expand your reach with authentic stories or recruit the right participants for a clinical trial, Reverba offers powerful insights and connections you can trust.  To learn more https://bit.ly/42s2Oed