Updated Guidance Provides Sense of Urgency to Improve Clinical Trial Diversity
Underrepresentation of ethnic and racial groups in clinical trials should be corrected quickly, according to a recent report from the National Academies of Sciences, Engineering, and Medicine.1 Additionally, the FDA issued draft guidance with recommendations for sponsors developing medical products to create an approach for a race and ethnicity diversity plan.2 The goal is to enroll adequate numbers of participants from underrepresented racial and ethnic populations.
“Local study investigators who apply for their own INDs [investigational new drug applications] or IDEs [investigational device exemptions] will be primarily impacted by the additional planning that will need to go into the development of their trial protocols and IND/IDE applications,” says Elicia Preslan, MS, CIP, IRB operations QA/QI manager at the Human Research Protections Program at Virginia Commonwealth University.
For study investigators, Preslan says there are some important considerations:
• Understand the epidemiology of the disease and local demographics;
• Research the current understanding of any disease/condition differences across racial and ethnic populations;
• Create robust statistical analysis plans that can measure differential effects;
• Plan community engagement efforts;
• Form collaborations with other study sites to increase enrollment and retention;
• Factor additional costs into the study budget for enrollment, recruitment, and reimbursement of participants. “For IRBs, the FDA guidance will have less impact. IRBs already review for equitable subject selection,” Preslan notes.3
To effectively implement the FDA’s guidance, Preslan says organizations must invest in research infrastructure to support investigators in enrolling and retaining diverse study populations. Organizations could help facilitate access to interpreters and translation services, offer childcare and transportation, improve physical accessibility of buildings, hire more study staff from underrepresented populations, create flexible work schedules that align with participant schedules, and/or form a community advisory board or navigation program. Investigators who lack access to such infrastructure can take these kinds of steps themselves.
“But it would require significantly more planning to build the effort and dollars into their budgets,” Preslan says.
Preslan recommends researchers consult the reviewing IRB early, before they submit their race and ethnicity diversity plan in their IND/IDE applications.
“The IRB is available to help advise investigators about the operational measures to enroll and retain diverse participants, as well as procedures for collaborating with other institutions and community groups,” Preslan explains.
Few researchers take advantage of this. In fact, the IRB can help connect investigators with all kinds of advice and assistance — other offices, investigators, and organizational resources. “Lots of researchers, especially new researchers, feel like they have to invent processes and form connections all on their own. But to do community engagement well and respectfully, it is better and easier to collaborate with others who have done it before,” Preslan offers.
Rachele Hendricks-Sturrup, DHSc, MSc, MA, says when researchers are approaching diversity in clinical trials, one component is “getting the science right” by ensuring populations are adequately represented. “But there’s another layer to that — it’s an equity component, to ensure that subpopulations that are affected the most by the disease, and thus stand to benefit the most from trial engagement, that they are specifically targeted for engagement,” says Hendricks-Sturrup, research director of Real World Evidence at Duke-Margolis Center for Health Policy.
Hendricks-Sturrup says the biggest takeaway for researchers “is to think about, as you endeavor to enroll a diverse array of participants in clinical trials: How are you being strategic about engaging key populations that are affected the greatest by the disease?”
Some researchers involve a representative of the targeted subpopulation, or a patient advocacy group, in the study design and recruitment planning.
“Planning enrollment goals early on with the community is critical. That way, you engage that community in a very transparent way,” Hendricks-Sturrup explains.
Community liaisons between the study investigators and people they need to recruit as participants can help build trust. For researchers, identifying advocates for specific marginalized subpopulations can be challenging.
“They’re hard to find, but I know they’re there. They do exist. It’s just a matter of finding them, being intentional about engaging with them,” Hendricks-Sturrup says.
These liaisons can help build trust with communities. “The sad part is that the populations we really need to reach, that would stand to benefit the most from engagement in trials, are the ones that might distrust the clinical research system the most,” Hendricks-Sturrup laments.
Members of the community who enjoyed positive experiences with study participation can help build trust.
“Don’t underestimate the value and impact of storytelling. That can have a profound impact among communities,” Hendricks-Sturrup stresses. “There’s an authenticity element as well. You can’t just go into the community and extract value without at least coming to the table to tell them, ‘This is how we will engage you in the short, medium, and long term. We are not here to exploit you or your community.”
Researchers also must “do a better job of meeting communities where they are,” Hendricks-Sturrup adds. Targeted study populations might lack transportation to appointments, or maybe they cannot take off work. Remaining flexible to eliminate those kinds of logistical barriers is crucial. For example, networks of community health providers could be the ones who interact with the study population instead of onsite research staff.
“There are a lot of opportunities to be much more inclusive, or to just be less rigid, in clinical trial management,” Hendricks-Sturrup says.
Hendricks-Sturrup and colleagues recently focused on point-of-care trials to explain how to integrate research into care delivery.4 In some cases, that approach can make it easier for people to participate in clinical trials. Clinical research participation would be embedded within their usual healthcare routine and at their usual healthcare provider locations. “It’s also about not abandoning the population in the end,” Hendricks-Sturrup adds.
Study participants in randomized, controlled trials may benefit from treatment administered during the study. But once the trial is complete, and the drug is approved and marketed, those same participants might not be able to obtain the drug.
“Those are legitimate concerns,” Hendricks-Sturrup notes. “To gain engagement and trust, researchers have to think about all of these things ahead of time, and contemplate questions and concerns that will come up in later phases of the trial, with the community’s input and goals in mind.”
1. National Academies of Sciences, Engineering, and Medicine. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. 2022.
2. U.S. Food & Drug Administration. Diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials; draft guidance for industry; availability. Federal Register. April 14, 2022.
3. Code of Federal Regulations. 45 CFR 46.111(a)(3). Criteria for IRB approval of research.
4. Propes C, Sheehan S, Hendricks-Sturrup R. Point-of-care clinical trials: Integrating research and care delivery. Duke Margolis Center for Health Policy. May 23, 2022.
Organizations must invest in research infrastructure to support investigators in enrolling and retaining diverse study populations.
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