Steps in the Right Direction

Maddie Gilmore, Class of 2023, Belmont Law

The representation or lack thereof of minority populations in clinical trials for new drugs and medical devices is a well-established issue. The Food and Drug Administration (“FDA”) is the administrative agency tasked with regulating the research required to accompany applications for approval of new drugs or devices as well as the standards to which the research is held. There are currently no substantive requirements for research that represents adequate racial quotas. The FDA instead, releases industry guidance and the guidelines warn corporate entities not to turn a blind eye to the need for minority populations to be adequately represented in clinical trials. Significant progress has been made, but the trend of progress does not mean that there is no room for improvement.

One reason inadequate representation is a persistent issue is a lack of access or open channels of communication to potential minority participants. This has sparked a discussion in the medical community about possible solutions, such as promoting and funding outreach or intervention programs. These programs are designed at building a referral network with those trusted, yet “research-naïve” physicians who serve as a conduit to opening channels of communication. These interventions would also contemplate providing access to childcare for purposes of easing participation in research, disseminating clinical trial information more widely and intentionally within communities of color, and educating both corporate entities and potential minority patients about areas of concern.

Considering these discussions, the National Cancer Institute (“NCI”) has created a new federal program designed at connecting underrepresented populations to clinical trials. The program is in the form of a federal grant which invites healthcare entities to apply by submitting a proposal for interventions. The program would then evaluate the proposals, and if found to be well-crafted and potentially helpful, implement it. The intervention proposal would be expected to be culturally tailored to focus on “accrual of underrepresented racial/ethnic (R/E) minority populations, to NCI-supported clinical trials. This will require outreach and education multilevel interventions at the CT site, provider, and/or patient levels.”

This is a unique opportunity that researchers and providers should be eager to take advantage of. In light of FDA guidance indicating such a strong and growing trend of industry focus on appropriate levels of minority-inclusive research, it is not unfathomable that eventually FDA will implement binding rules and regulations to the same effect. A forward-looking entity will recognize the need for eventual compliance. Should such rules ever come into effect, the game of catch-up may be an insurmountable hurdle. Considering this trend, why not take advantage of this federal grant? In addition to the financial assistance, participation even in the application process will ensure that the entity is well informed by relevant theories, frameworks, and models. Unfortunately, many providers and patient level physicians will not take advantage of this unique opportunity.

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