Need Minority Patients in Your Trials, Find Minority Investigators
[Thursday, March 28, 2019]
Minorities represent a small fraction of subjects participating in clinical trials. A good way to improve minority participation in clinical trials could be through investigators from these communities. In an essay published this week, Dr. Kyle Mack, a Chicago doctor, who is African-American describes how being from the community opens doors for him to get increased participation in his blood donation drives in that community. The same could potentially work for clinical trials recruitment as well. Lack of minority participants in clinical trials is the major reason why most new products are approved with under-representation of data from minorities and hence a lack of reliable treatment options for minorities. For drug approved with little or no data from minority subjects, the expected treatment outcome cannot be reliably estimated. FDA has several programs to encourage minority involvement in clinical trials and participation in regulatory processes, but all data indicate limited success. There is no regulatory requirement to increase data from minorities leaving little incentive for developers to push for minority populations in their trials despite good intentions. That leaves communities to fend for themselves in terms of access to clinical trials. There is significant mistrust in minority communities for clinical trials and pharmaceutical companies. Doctors from these communities can help bridge the divide between perceptions and realities. Participating in clinical trials offers access to state-of-the-art new treatments, comprehensive diagnosis, increased attention from the clinical trial teams, robust monitoring for safety and efficacy, and even compensation for participating. By not participating minority communities miss out on the opportunities to benefit from the system and also from contributing to important research that would help the same communities over the longer periods. It is easier for these communities to trust doctor who are also minorities, so if a sponsor seriously wants to recruit more minority patients, an easier solution could be recruiting minority physicians as investigators first. FDA can also encourage minority physicians to participate and in turn educate their patients. With the abysmal minority participation in clinical trials for almost all indications, any small change in strategy helps and including minority physicians as investigators is no small effort.