Concern over the lack of significant minority participation by patients in clinical trials has waxed and waned over the past 30 years. Now, there is growing momentum in favor of boosting the numbers—and it's about time, because minority patients can no longer wait. We need to do something now to improve health equity by ensuring that new medicines are tested for safety and efficacy in all populations.
Clinical trials conducted today in the United States lean heavily toward populations that are 80-90 percent white, as reported in a recent Scientific American editorial. Failure to give people of color the opportunity to participate in trials to is unacceptable when close to 40 percent of the United States population belongs to a racial or ethnic minority group. Further, it is estimated that minorities will represent the majority in the United States population by 2050.
Most individuals involved in medicine, research, and public policy agree this is an unbalanced equation. The products developed in these trials—drugs, biologics, and medical devices—might not be best suited for certain minorities. Some minorities are affected differently than white people by diseases, and react differently to medical treatments. But who they are and how they’re affected cannot be known when some groups are not included in the studies designed to test these medicines.
Government agencies such as the FDA and companies that sponsor clinical trials have been tackling the diversity issue for some years, with limited progress. Public policy and regulatory solutions alone cannot increase minority participation in clinical research.
One solution is a unique program we at Clinical Research Pathways developed with Morehouse School of Medicine in Atlanta. Called "Training Minority Clinical Teams: Getting New Quality Medicines to All Americans," it seeks to knock down barriers to minority participation trials. The key, we strongly believe, is to rely on the trusted, ongoing relationship between minority physicians and their patients. We already know that within these bounds, patients are more willing to listen to advice.
The program involves two principal steps:
First, the program addresses the lack of minority physicians who serve as site investigators for trials. In most cases, they’re simply are not asked to lead trials or are not informed about them. Morehouse School of Medicine, led by professor and Research Vice Chair and Project Director Dr. Prisicilla Pemu, is recruiting more minority physicians to lead clinical trials. Dr. Pemu and her team will work with MSM's extensive network of physicians to inform them about the need to lead clinical trials. Today, for example, Morehouse School of Medicine has 134 physicians who serve 110,000 patients. The Morehouse Community Physicians Network includes another 133 physicians who work with close to a half-million patients
As more minority physicians are recruited, they will be trained on how to conduct clinical research and on the best practices for doing so. Physicians will also receive ongoing mentoring and support while they conduct trials.
Second, these same minority physicians will be trained in how to open dialogues with their patients where appropriate, explaining the rationale for becoming a trial participant. Patients will thus hear from someone they already trust, and who has their interests at heart. Physicians in these situations are best suited to explain to patients why participating in a trial not only potentially benefits them, but also others in their racial or ethnic group. This is where the primary gap exists today: For the most part, minority patients don't hear about clinical trials from trusted sources nor are these patients encouraged to participate.
The Morehouse School of Medicine program also takes advantage of the school's unique position as a trusted voice among minorities in Georgia. Including their voice to the ongoing dialogue alone is a significant step forward.
In its first year, the program will focus on cardiovascular disease, the leading cause of death worldwide and one that presents an even higher risk for African-American and Latino patients. Later, the program will expand to include cancer, neuroscience, and arthritis. One of our overall goals is to double the number of minority physicians who lead clinical trials in Georgia. We eventually hope to expand this program nationally, using what we've learned in Georgia.
We also believe that training provided during this program will help minority physician/investigators become better researchers overall. We intend to encourage them to take what they learn in this program and apply it to other research they might conduct in the future.
It is important to note that the program we funded at Morehouse School of Medicine is just one step toward the goal of increasing minority participation in clinical trials. I and others involved in our organization have always focused our diversity efforts around one theme: Those who are left out of research run the risk of being left out of the cure.