Diversity is also part of FDA studies

Biography: Hovanesian is on faculty at the UCLA Jules Stein Eye Institute and in private practice at Harvard Eye Associates in Laguna Hills, California.

Disclosures: Hovanesian reports that he is a principal investigator in dozens of FDA clinical trials, but has no relevant financial information on this topic.

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Achieving diversity in our physician ranks is not just about fairness to all. It is also a practical question.

Filling our medical specialty with a representative number of doctors from all ethnic groups, men and women, is partly about tapping into the pool of available talent. It’s about getting capable people of all kinds to pursue careers in medicine who might otherwise fear obstacles that make an already competitive career pursuit seem futile. If you need to capture top talent, cast a wide net.

John A. Hovanesian

Diversity among healthcare professionals also offers patients like-minded primary care and specialty caregivers, which is especially beneficial for populations who have traditionally been less likely to access or trust our healthcare system. .

But if these various doctors have drugs and devices that have only been tested on white subjects, what confidence can they – or their patients – have in our science? In a world where we have recently and painfully learned that minority populations have far less faith in the coronavirus vaccine than their white counterparts, we know we need to do better. Research studies, especially pivotal trials leading to the approval of new drugs and devices, need to be more racially balanced.

How do we do this? This will certainly help diversify our ranks of researchers, but it will take time. Meanwhile, when we have a new drug or device being tested, we have to deliberately find the target populations that we hope to eventually treat. Chances are, that doesn’t just mean middle-class suburban whites who are free of other illnesses.

Clinical trial designs, particularly for patients with chronic or severe disease, should also consider and allow for the inclusion of comorbidities, even those that directly or indirectly affect (through the drugs used to treat these diseases) the effectiveness of the study treatment. For example, if we are testing a new treatment for eye inflammation, how can we summarily exclude all patients with other forms of body inflammation who may or may not be on treatment, such as patients with arthritis taking NSAIDs? Does this confuse science? Of course it is. Does it make a clinical trial more relevant that tells clinicians how and where the drug really works? Yes, and that enlightenment is probably well worth the mud.

Going back to representation of 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 fully supports this effort, as evidenced by its 2020 guidelines on “Enhancing the Diversity of Clinical Trial Populations.” Representing the target population in these studies not only strengthens the quality of the endorsement, but it is the right thing to do for our increasingly diverse patient population.

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