In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee meeting in April, Drs. Rosa Gonzalez-Guarda, Rachel Gold, and Karen A. Kehl discussed the importance of including diverse participants in pragmatic clinical trials and the challenges investigators and community health centers face engaging underrepresented populations in research.
During the discussion, Gonzalez-Guarda, Gold, and Kehl identified some of the challenges investigators must address in order to include diverse populations in pragmatic trials, such as inequalities in access to healthcare, under-resourced community health centers and funding mechanisms that do not accommodate research in community settings, and lack of infrastructure for research in settings outside of academic health centers.
“I think the biggest challenge that we have is that we know there are inequities in access to healthcare to begin with so if we are not thoughtful about the integration of pragmatic clinical trials within a system that already lacks accessibility to many populations, I think that is a huge challenge that we need to overcome,” said Gonzalez-Guarda of Duke University.
Changes to the way research is funded is one step that could better support research that includes diverse populations.
“Through the Collaboratory, we have used a lot of collaborative mechanisms that allow some of that building of community-based resources in the planning phases,” said Kehl of the National Institute of Nursing Research. “The Collaboratory and HEAL Initiative have had some particular supplements that are looking just at engaging diverse populations and adding to the diversity and inclusion of a study.”
Other areas to focus on include building relationships within the community, developing partnerships and infrastructure for research at community health centers, and ensuring the study content is of interest to the clinic and patients.
“My experience of 15 years of doing pragmatic trials with community health centers has focused on outcomes that are of most interest to the primary care providers, which is a lot of times going to be around maternal-child health, opioid pain management, hypertension, and diabetes—what the patients are coming in for the most and in a lot of cases [what] the clinics have a quality metric that they have to report on,” said Gold of Kaiser Permanente Center for Health Research.
Gonzalez-Guarda hopes the NIH Pragmatic Trials Collaboratory will help lead the way in putting change into action.
“There’s a lot of expertise already in the Collaboratory and success on engaging diverse populations, not only as participations of those studies [but also] as partners, and those are things that I would love to elevate and integrate into our Living Textbook as well as creating some trainings,” Gonzalez-Guarda said. “Another strategy that we need to think about is diversifying the workforce of individuals and investigators that have the expertise in this area because we do know that makes an impact in terms of encouraging diverse participation and engagement in clinical trials.”.
See the complete materials from the 2022 Steering Committee meeting.