The Path Ahead to Improve DEI in Clinical Trials

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On June 26, 2024, the FDA released updated guidelines for diversity, equity, and inclusion (DEI) in clinical trials. The guidelines, titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” was drafted with the goal of assisting with the submission of Diversity Action Plans to support certain clinical studies.

According to the agency, the purpose of a Diversity Action Plan is to increase clinical study enrollment of participants from historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the product.¹

“Participants in clinical trials should be representative of the patients who will use the medical products,” said Robert M. Califf, MD, commissioner, FDA, in a press release. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”

In an interview with Applied Clinical Trials, Gadi Saarony, CEO, Advarra, discussed the FDA’s influence on DEI in clinical trials, current recruitment challenges, and the importance of addressing it beyond meeting regulatory requirements.

“For us, this conversation has been going on for quite some time,” said Saarony. “The FDA guidelines have provided a higher level of focus on it. When we speak to our clients, it’s not just us saying something, but we’re also referring to a guideline and explaining how important this is to the FDA. So, from that perspective, I think it’s bringing something that pharma is already thinking about to the forefront but is struggling to do something about it. Anytime we have some sort of framework, it helps us shape the conversation in terms of influencing diversity in clinical trials.”

Regardless of the FDA guidelines, there are a number of challenges that can still be improved upon. Saarony stressed that the recruitment process must remain ethical for the duration of the trial.

“For me, part of the ethical question is if the right patients are being included in clinical trials,” he explained. “In terms of having conversations with clients that are recruiting, there are a number of other areas that we need to look into at a deeper level. What are the things that are causing a lack of diversity and inclusion in clinical trials? A lot of companies talk about it and wish for it. They even do the right things in terms of looking to recruit those types of patients, but the reality is that it has to start with a protocol.”

Another potential avenue to improve DEI in clinical trials is additional support from patient advocacy groups. Jennifer Kim, Tufts Center for the Study of Drug Development, Tufts School of Medicine, Boston, MA, recently spoke to Applied Clinical Trials to offer her thoughts on how this could be achieved.

“I think patient advocacy groups and community outreach organizations, whether it’s a church, community center, or people in those communities trying to reach others, have a big role to play when it comes to outreach and building rapport among marginalized communities,” said Kim. “There’s a lot of research that shows that people tend to trust people that look like them, talk like them, and have similar life experiences as them. It’s basically human nature.”

Kim also brought up a recent study that she worked on at the Tufts Center that emphasized the importance of peer groups in influencing others to participate in clinical research.

“One of the recent studies that we did at the Tufts Center for Drug Development found that one of the single most important things that motivated a person’s willingness to participate in a clinical drug trial was having previous participants within one’s network,” explained Kim. “Having someone within close proximity of your social network who had previously participated in a clinical trial was the strongest predictor that determined whether someone was open to participating in a clinical trial. I think that illustrates just how important word of mouth is, and that’s where community outreach groups need to start.”

Kim’s statement is backed up by Advarra, who have stated that DEI in clinical trials requires a concerted effort from trial sponsors, researchers, healthcare providers, community organizations, and individual participants. According to the company, diverse clinical trials can generate useful, inclusive data for regulatory review and to develop safe and effective treatments that work for all patients and healthcare professionals involved.²

“I think there needs to be a shift in priorities towards adopting a multi-pronged approach, and what I mean by that is looking at not just the systems that you have in place, but also looking at the workforce,” said Kim. “You have to ask yourself if the team reflects the lived experiences of the patients that we’re trying to reach. That starts with the people that are designing the protocol, approving the protocol, and all the way down to the people who are actually interacting and spending the most amount of time with the patients. Can they speak to the experience of the people that we’re trying to reach? Often times, we know that’s not the case. So, it’s about reshaping it from a holistic perspective.”

References

1. FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies. FDA. June 26, 2024. Accessed November 1, 2024. https://www.fda.gov/news-events/press-announcements/fda-guidance-provides-new-details-diversity-action-plans-required-certain-clinical-studies

2. Diversity, Equity, and Inclusion in Clinical Trials. Advarra. Accessed November 1, 2024. https://www.advarra.com/services-for/diversity-in-clinical-trials/#:~:text=In%20order%20to%20effectively%20achieve,community%20organizations%2C%20and%20individual%20participants.