Q&A – Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
In our latest webinar, a panel of experts from research organizations, Community Health Centers (CHCs) and healthcare tech discussed racial diversity in clinical trials and ways biopharma and CHCs can come together to improve equity in research. Additionally, they covered how to unlock the inherent trust between patients and community healthcare providers (HCPs) to encourage diverse representation. Due to time constraints, we weren’t able to answer all audience questions during the Q&A period, so our experts have answered some of the most popular questions in this blog.
Q: Are the CHCs serving underserved communities predominately Federally Qualified Health Centers (FQHC)s? Is there anything about the FQHC designation or how they work that would prevent them from conducting their own research (vs referring to nearby research sites)?
A: FQHCs must meet a number of requirements (including serving individuals in “medically underserved” areas) that require a structural focus on healthcare delivery and limiting the ability to invest in research-related infrastructure. As such, in order to improve FQHC patients’ access to research, we’re best suited to understand how to involve FQHCs in a way that has minimal operational burden and fits within existing workflows and infrastructure.
Q: What is the best way to get HCPs to promote research with their patients?
A: We feel that standardizing clinical research as a part of care is the best and most effective strategy in the short term and long term. These conversations should occur at every clinic visit, irrespective of the availability of a specific trial. They do not need to be long (can be 30 or even 15 seconds), but normalizing this discussion and increasing awareness about what clinical research is and isn’t is a crucial way to improve overall and diverse recruitment. Failing this, well-organized handouts, perhaps in the form of folders, can help HCPs stay on top of research and provide a great resource for patients too.
Q: Is there a way to set up CHCs as research sites so patients don’t need to leave their community or HCP to participate in a trial?
A: The rise of clinical trial networks may have a benefit for precisely this reason– the rise of the hub-and-spoke model, which centralizes some aspects of clinical research (hubs) to lower the administrative burden for partner sites (spokes). The organization is a bit more complicated than this, but it opens up the possibility of ensuring patients can do most, if not all, of their research visits at a trusted partner’s site. This might even be extended to local CVS or Walgreens locations. There is likely a continuum of CHC participation based on a variety of variables including infrastructure, geography, etc. This could range from focus on patient outreach and awareness about nearby trials all the way to participation in research activities as an investigator or sub-investigator.
Q: I think the essential piece is building trust before we even have a research idea. How do we in clinical research mobilize to do this collectively?
A: Trust is crucial. But in the world of clinical trials it is not emergent on its own. Instead we need to perform some empowerment and capacity building within communities that we’d like to recruit from. There is simply no sustainable path to trust alone given our problematic history of abuse and lack of diversity in clinical research. Instead we must measure and incentivize true engagement and education, separate from and before recruitment, in our clinical research organizations, and ensure recruitment plans prioritize this as much as accrual to studies.
Q: How can we get more participants and patients engaged in community advisory boards (CABs) and protocol development? How can we involve community members more in research?
A: More flexibility and stronger incentives are useful here. Many CABs are volunteer opportunities, or meet irregularly, at inconvenient times. Demonstrating the power of patient voices by showing how their suggestions made a difference, demonstrating the value of their expertise by paying them more than $10-20 or planning around them is a way of encouraging broader and deeper involvement. The other way to include community members more is to expand and better advertise IRBs. Discussing IRBs and their role in regulating research is very enticing to underrepresented communities. To the previous question, this is another way of building trust through empowering communities.
Q: Researchers should build funds into their budgets, grants, etc. to access translators, transportation, etc. as a standard practice. How do we start doing this?
A: Adjust templates and expectations to normalize budgeting for these during the project pre-proposal and formal proposal phases. Encourage researchers and funders to revise their internal estimates for study budgets to allow for this or retain partners for rapid translation contracts with transportation organizations. Generally, these do not have to be substantial expenses, especially if they are allocated at the level of organizations rather than individual protocols.
Q: Any thoughts about changing the dynamics of engaging with clinical providers?
A: We often talk about incentives for participants, but we should ensure incentives and value for clinical providers. That can be co-authorship, appointment as study co-investigators, protected time for research, support in disease management, or some combination of these.
Engaging outside non-research clinical providers and staff to educate them about nearby relevant research and identifying ways that they can introduce research to patients within their existing workflows is key. Research suggests that patients’ most trusted source of research info is their own provider, and furthermore, community providers would like to be able to introduce research opportunities more to their patients. There’s a real opportunity to engage beyond the walls of investigator sites and into the community.
For more information on how to increase diverse enrollment in clinical trials and overcome root causes of research inequity, watch the webinar Racial Diversity in Clinical Trials: Building Trust in Participant Engagement.