A recent article in The Pink Sheet highlighted FDA Commissioner Rob Califf’s concerns about health equity. In his address to the Alliance for a Stronger FDA, Califf said, “I worry sometimes that the focus on diversity in clinical trials is really sort of a distracting maneuver from the underlying issue of lack of health equity in our health care system. I’m pretty sure if we fix the lack of equity in our health care system, the clinical trials would follow suit. Having said that, I’m all for it, and we’ll work hard on helping to increase diversity in clinical trials.”
A hand-in-glove approach to drive health equity
The lack of clinical trial diversity is a longstanding issue that the research community is only beginning to address. While Califf’s position is understandable, clinical research should not be disconnected from healthcare delivery. In fact, diversity initiatives in clinical trials taking place today can accelerate broader health equity. Patients are beginning to have more participation opportunities through primary care settings, retail pharmacies, and even mobile clinical research units, in the case of COVID vaccine trials — a model that can be easily replicated for other large-scale studies. What’s more, clinical trial diversity initiatives don’t necessarily have to follow efforts taking place in the bigger health care ecosystem. As general awareness of clinical trials continues to grow and more patients seek clinical trials as a treatment option, consider all the ways that clinical trials can drive health equity:
- Clinical trials serve as a bridge for access to healthcare by providing access to clinic visits and tests at no cost. We can continue to expand awareness through outreach and engagement across the communities we serve. Look to trailblazing examples from the Morehouse School of Medicine and the Yale Center for Clinical Investigation for effective work in progress.
- A complete healthcare offering includes the treatment options available only through clinical trials. Clinical trials offer alternative health care options when the standard of care doesn’t work or when side effects are intolerable. When you consider the high unmet needs and rich pipelines in oncology, CNS indications, and infectious diseases alone, clinical trials offer the potential for life-changing outcomes.
- A truly inclusive approach to research does not mean targeting diverse populations but making research more accessible to everyone, which will naturally attract a representative sample of the population. This approach requires taking research into the community beyond the academic medical centers. We need more community research sites, partnerships with community physicians, and supportive services like the patient navigator programs to help bridge the gap.
- Some segments of the population, such as undocumented persons, fear interaction with the medical system and may be attracted to clinical trials. The numerous barriers to health care for undocumented immigrants are a growing issue that demands our attention and thoughtful solutions on local and national levels.
Ultimately, clinical trial diversity is achieved by the same means as health equity: education and access, so it’s time to do more to make clinical trials more connected to healthcare delivery and part of the continuum of care.
Author: Matthew Maxwell, Chief Marketing Officer