BLOG: Diversity belongs in FDA studies, too
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Achieving diversity in our ranks of physicians is not just about fairness to all people. It’s also a practical matter.
Filling our medical specialty with representative numbers of physicians from every ethnic group and both men and women is partly about drawing from the full pool of talent available. It’s about driving capable people of every sort to pursue careers in medicine who might otherwise fear barriers that make an already competitive career pursuit seem futile. If you need to capture the best talent, cast a wide net.
Achieving diversity among medical professionals also gives to patients both primary care and specialty caregivers who look like them, which is especially beneficial for populations that are traditionally less likely to access or have trust in our health care system.
But if those diverse doctors have drugs and devices that were tested in only white subjects, how much confidence can they — or their patients — have in our science? In a world where we recently and painfully learned that minority populations had significantly less trust in the coronavirus vaccine than their white counterparts, we know we must do better. Research studies, especially pivotal trials leading to approval of new drugs and devices, need to be more racially balanced.
How do we do this? It will certainly help to diversify our ranks of researchers, but that will take some time. Meanwhile, when we have a new drug or new device undergoing trials, we need to deliberately find the target populations we hope to eventually treat. Chances are that doesn’t mean just white people in middle-class suburbs who are free of other disease.
Clinical trial designs, especially for patients with chronic or serious disease, also need to consider and allow the inclusion of comorbidities, even those that directly or indirectly (through the drugs used to treat those diseases) affect the efficacy of the treatment under review. For example, if we’re testing a new treatment for inflammation of the eye, how can we summarily exclude all patients with other forms of bodily inflammation that may or may not be under treatment, such as patients with arthritis taking NSAIDs? Does that muddy the science? Of course it does. Does that make for a more relevant clinical trial that tells clinicians how and where the drug really works? Yes, and that enlightenment is probably well worth the mud.
Getting back to representing all ethnic and racial populations, we need similar enrollment criteria to balance the mix of patients in clinical studies to approve new drugs. Fortunately, the FDA is squarely behind this effort, as evidenced by its 2020 guidance on “Enhancing the Diversity of Clinical Trial Populations.” Representing the target population in these studies not only bolsters the quality of the approval — it’s the right thing to do for our increasingly diverse patient population.
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