NEW YORK – The Personalized Medicine Coalition on Wednesday published a report detailing steps researchers can take to increase the engagement and inclusion of diverse populations in clinical trials.
Historically, federal policy recommendations in the US have failed to move the needle on participation of underrepresented minorities in clinical trials. In 1993, the National Institutes of Health Revitalization Act established guidelines for the inclusion of women and underrepresented racial and ethnic minority populations in clinical research, and about five years later, the US Food and Drug Administration issued a rule requiring that gender, age, and race information of clinical trial participants be included in new drug applications.
Since then, drugmakers have increasingly focused on developing precision medicines for small subgroups of patients who harbor disease-associated biomarkers. Identifying and enrolling patients with these rare biomarkers is challenging and hasn't made it any easier to overcome historic inequities in clinical trial enrollment.
In 2021, a study published in JAMA Network Open evaluating participation in biomarker-driven breast, prostate, lung, and colorectal cancer clinical trials found that minority racial groups were still underrepresented compared to white participants relative to the incidence of these diseases in these groups in the US. The FDA issued draft guidance in 2022, proposing nonbinding recommendations for increasing patient diversity in clinical trials, but clinical trial sponsors continue to struggle with a lack of diversity among enrolled patients.
The PMC, a nonprofit organization that advocates for the development and adoption of personalized medicines, is hoping its recommendations will add to past efforts and provide actionable strategies that researchers can use to translate aspirational inclusion goals into real-world progress on conducting more equitable clinical trials. The report includes two sets of recommendations, one on community engagement in research and the other on the collection and use of inclusive health data.
The community engagement recommendations address the need to support and fund community-based organizations; increase funding for qualified rural health centers, urban Indian health programs, and rural health clinics; increase community involvement within institutional review boards; and recruit investigators from diverse backgrounds for personalized medicine research.
In the health data category, the PMC recommends filling gaps in real-world data sources to include information on underrepresented groups; improving systems that capture and share data related to social determinants of health in electronic health records; and boosting resources for community programs, in which that data can be shared.
Silas Buchanan, the founder and CEO of the Institute for eHealth Equity and one of the 25 members of the health equity task force that authored the PMC report, said these recommendations are needed to help the life sciences research enterprise engage with minority communities in a more consistent and sustainable way. "Communities are tiring of the episodic approach and engagement by research institutions" that are attempting to improve diversity, equity, and inclusion without understanding how to effectively connect with minority communities, Buchanan said.
The Institute for eHealth Equity, an organization founded in 2011 to promote health equity, is trying to implement some of these health data-related recommendations with Our Healthy Community, an online platform in development that will connect stakeholders, patients, and community advocacy organizations to collaboratively address health disparities in healthcare and clinical trials.
When complete, Buchanan said, the platform will create an "ecosystem" enabling the continuous flow of information that, among other things, will allow research organizations to better engage with and support members of minority communities and recruit diverse participants from these groups, instead of periodically bombarding communities with pleas for trial participants, as is presently the case.
"We can create private, password-protected spaces just for the leaders of community-facing organizations to co-create the collateral material [with patient advocacy or research organizations] that could then be used to reach community members," Buchanan said. "They're not just saying, 'Hey, it's breast cancer awareness month, can you put this in your church bulletin?'"
Buchanan believes that the clinical trial matching features of Our Healthy Community will be one of the main benefits of the platform. He noted that physician-scientists, cognizant of the historical exploitation of Black patients and other minorities in medical research, can often hesitate to approach people of color when recruiting for trials. This leaves the tough task of finding clinical trials they qualify for up to the patients.
"There's an opportunity to improve diversity and inclusion in clinical trials, but it is still very difficult for an individual patient to ferret out the right one," Buchanan said. The report's recommendations on community programs, if embraced by the research community, would go a long way toward lifting much of that burden off the patient's shoulders.
Buchanan noted that while it's important to increase health literacy in minority communities, the report also calls for increased cultural competency and humility among researchers. As an example, Buchanan pointed out that women of color are disproportionately impacted by breast cancer, particularly triple-negative breast cancer. Added to this, differences in educational level, work, and access to transportation may make it even harder for people of color to access the tests and treatments they need compared to a typical white patient.
"Can they get their prescription filled and adhere to a medication regimen?" Buchanan said. "Who determines that the bus is supposed to stop running at 4 p.m. or stop running altogether on a route that it has run for the last 50 years?"
And while practical solutions such as transportation or other accommodations for minorities can help, Buchanan cautioned that physicians also need to understand and be sensitive to the experience of systemic racism itself, which often leads patients to feel intimidated or misunderstood in medical settings.
Buchanan also pointed out that communities near prestigious urban healthcare systems often have worse health outcomes than surrounding areas. As an example, the Cleveland Clinic's 2016 Community Health Needs Assessment noted higher rates of mortality for heart disease, homicide, aortic aneurysm, HIV, traffic accidents, and some cancers in Cuyahoga County where the hospital is located, as compared to the Ohio average.
The PMC report addresses that problem head-on by noting the need for greater resources to recruit more investigators from diverse backgrounds who can lead personalized medicine research studies within underrepresented communities. To facilitate this change, the report suggests beginning with diversity, equity, and inclusion initiatives at research institutions and organizations, including unconscious bias training and mentorship programs and actively fostering early-career scientists from underrepresented groups.
Ultimately, the PMC would like to see research organizations and others commit more resources to "build capacity and benefit the community."
"There needs to be some compensation modeling there," Buchanan noted, as well as a system to report back de-identified, aggregate data so that communities can benefit and learn from the research their members are participating in.