The US Food and Drug Administration (FDA) released a diversity-focused draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” on June 26, 2024. I sat down with Lya Rebelo, commercial enablement manager at Citeline, to discuss the future impact of this long-awaited guidance, how it differs from previous FDA diversity guidance, and what Norstella is doing as a life sciences partner to facilitate more diverse clinical development.
Diversity in clinical trials is crucial to ensuring that medicines reach a diverse patient population. Historically, many trials have lacked representation from minority groups, which can lead to gaps in data about how treatments work in different demographics.
The three main areas that I think could be improved are:
• Recruitment strategy: How can sponsors target, engage, and retain those diverse patient populations and their respective communities? Looking at social determinants of health (SDOH) will be able to support that area where we see inequities in terms of getting a good education, a good income, or being within a certain distance from a hospital that is enrolling for a clinical trial.
• Eligibility criteria: This would mean looking back at a protocol when designing a clinical trial to avoid strict inclusion criteria that might exclude diverse patient populations. In the past, most clinical trials enrolled white males, so it was not representative of the whole world.
• Community engagement: How can sponsors build trust with communities through education and partnerships? How can they make treatments more accessible to the community? So, it’s all about accessing that underrepresented patient population and, for example, translating clinical trial materials which shows the effort to work together to improve outcomes.
All in all, the industry should establish recruitment goals based on the epidemiology of global populations and refine these goals as the protocol becomes available. I believe this strategy can be achievable if implemented early in the trial design process.
Diversity is not new. The FDA has released many guidance documents in the past about collecting race and ethnicity data and has been encouraging sponsors to be more diverse when they develop new medicines.
The most recent diversity guidance now takes into account the Food and Drug Omnibus Reform Act (FDORA), which was signed into law in December 2022 and expanded the definition of diversity. Some people define diversity as race and ethnicity, whereas now, with the FDORA, it is more about the underrepresented patient population. It looks at age group, sex, race, geographic location, socio-economic status, and ethnicity.
One critical point in the recent guidance concerns encouraging early and continuous engagement with diverse patient populations throughout the clinical trial process. So, as sponsors consider the epidemiology of the disease, how can they show that the inclusion criteria reflect the incidence of the disease when they develop the protocol?
SDOH can inform recruitment strategy, making sponsors consider things like: Do patients have the money to take a day off work to take a blood test? Are they near the site where the clinical trial will be performed? These types of questions should be asked throughout the clinical trial process.
The guidance also talks about inclusive study design. In other words, when sponsors design their trial, they should start to have that diverse population in mind from the beginning as they develop the protocol. Additionally, the guidance addresses transparency, so reporting the demographic data on trial participants to highlight areas that need improvement is crucial.
The changes that I noticed were quite significant. There were three big changes from the FDA’s last guidance released in 2022 to the most recent guidance. Of course, FDORA puts a lot of pressure on the FDA. Now sponsors really need to act, and the guidance also gives the FDA the power to enforce it.
One change was the increase in specificity. This guidance now provides more detailed recommendations on operationalizing diversity trials. Before, they only recommended areas that sponsors should be looking at, and now they are pretty specific to the point that their appendix is the template of how the diversity action plan should look like. They even mentioned that they were expecting a maximum of ten pages.
The second big change I noticed is the strong emphasis on accountability. There is a greater focus on sponsors’ accountability to meet diversity goals in terms of encouraging them to add their diversity goals to their website and be more transparent when clinical trials are open.
Finally, as mentioned previously, because on the FDORA there’s a broader scope, the FDA is now expanding the focus to include more comprehensive diversity measures, including socioeconomic status, geographic location, etc.
The recent guidance is promising. It provides a clear framework and expectations for improving diversity to facilitate better representation so that more inclusive trials can lead to more efficient results.
I also see this guidance improving public health outcomes by enhancing the understanding of how treatments work across different populations. For example, COVID allowed for more education on clinical trials. So, as we start to offer clinical trials to more minority populations that might not have as much access to join clinical trials, it could significantly improve public health.
I’m a chemist at heart, and I love that diversity is about improving efficacy and safety data to understand how different groups respond to treatments. So, for me, the importance is about how we can improve efficacy and safety, as we know that one size does not fit all. The other part is all the public health benefits as a result of developing effective treatments for all demographics, which, in turn, reduces health disparities.
We can help organizations submit a diversity action plan at every step of the process, from our real-world data (RWD) to products and services designed to support sponsors.
We have recently launched Global Patient Insights which seamlessly integrates RWD on patient population and diversity with Sitetrove’s best-in-class site and investigator intelligence. This robust dataset enables study sponsors to select the best possible geographic locations, sites, and investigators for their clinical trials. By fine-tuning your site and investigator selection, you will avoid missing enrollment targets and incurring associated costs.
For more information on the recent FDA guidance, check out Lya’s full article: Deciphering the FDA Diversity Plan Updated Guidance
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