An industry emphasis on improving inclusion and diversity in clinical trials continues to grow, but strategies to achieve more balanced representation in research and clinical care remain elusive.
To address the issue, representatives from the nation’s top academic research institutions and government health organizations collaborated with thought leaders from health care companies, patient advocate organizations, and community and faith groups as part of a DCRI Think Tank on April 28 and 29, 2021. Together, they identified disparities in engagement in clinical trials and determined a set of actionable steps to improve diversity in clinical trials, which would ensure better information for improving the health of all populations and reduce health disparities. A manuscript resulting from the collaboration, recently published in Contemporary Clinical Trials, provides clear steps to drive change and improve inclusion and diversity in clinical trials.
DCRI Think Tank participants identified three strategies that investigators and institutions could implement to improve inclusion and diversity and drive lasting change in clinical trials:
- Build engagement and partnerships with participants. Ensuring participation is offered and advertised to diverse populations is an important step. Community engagement is a key part of recruitment and retention of underrepresented groups.
- Improve accessibility of clinical trials, either physically or digitally. Institutions can improve accessibility by investing in non-traditional and novel types of sites and by utilizing infrastructure already embedded in communities. They can also leverage digital health and telemedicine tools to gather data, communicate with participants and reduce geographical barriers to participation.
- Improve representation among clinical investigators to better reflect the desired patient population. This requires ensuring that individuals representing the communities of interest are given ample opportunities to join and lead research teams, and providing the support and mentorship necessary for them to thrive within the field.
The paper notes that while many individuals are open to participation in clinical trials, some have concerns about mistreatment and exploitation. These concerns are elevated among racial and ethnic minorities in particular, and are not without historical precedent.
To combat these concerns, DCRI Think Tank participants recommended that investigators and institutions build partnerships in underrepresented communities, demonstrate trustworthiness, acknowledge previous wrongs in research and commit to humanizing clinical participation and the clinical research experience.
“The one that sticks out to me – the core, the foundation – is this idea of linking and engaging with the community of individuals who have not yet had the opportunity to engage as much in clinical trials,” said Gerald S. Bloomfield, MD, MPH, DCRI faculty member and principal investigator. “Before you jump to metrics or increasing the percentage of this group or that group, you really have to speak with people. When we’re in the ivory towers, or in the board rooms or in the c-suites, we make a lot of assumptions about the need for diversity and inclusivity, assumptions about causes, assumptions about interest or awareness. We can easily try to fix problems without actually addressing the root of the issue or knowing what the issues are.”
Members of the DCRI Think Tank acknowledged barriers to accessing clinical trials for certain populations, which could be reduced or alleviated by considering non-traditional sites, utilizing infrastructure already embedded in the community, and leveraging digital health and telehealth tools.
Finally, the DCRI Think Tank participants emphasized the importance of diverse representation among the investigators conducting the trials.
Providing clear guidance and actions that researchers and institutions can take to improve inclusivity in research marks an important step toward reducing health disparities and making health care more equitable for all.
“You can talk about theory all you want, but ultimately you need advice and guidance, and that’s what we wanted to come out of this particular discussion – we wanted concrete steps to fix this problem, because there’s a real problem in the research space,” said Michelle Kelsey, MD, lead-author of the manuscript, a cardiologist, and second-year fellow with the DCRI. “It’s great that the DCRI Think Tank program tackles the hard subjects – the subjects that really need to be discussed, and getting all of the key stakeholders together is a really powerful experience, so that was a great thing to be a part of.”
Co-authors of the manuscript and participants in the DCRI Think Tank included representatives from government health organizations including the National Institutes of Health and the U.S. Food and Drug Administration, health care and pharmaceutical industry leaders including Evidation Health, Inc., Sanofi, Boehringer Ingelheim, ClinArk, SiteBridge, Verana Health, and Pfizer, and academic institutions including City University of New York’s Hunter College, and Rutgers-New Jersey Medical School.
Other DCRI Think Tank participants and contributors to the manuscript include Lesley Curtis, PhD, and Robert Mentz, MD.