Recruiting a diverse patient population a must for clinical trials
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I have shared my thoughts on diversity, equity, inclusion and social justice in the U.S. regarding racial distribution in ophthalmology in three prior Lindstrom’s Perspectives.
The interested reader can look them up (Jan. 25, 2021, May 25, 2022, and Dec. 25, 2023). Prior issues discussed were the racial distribution of practicing ophthalmologists, leaders in ophthalmology and patients in live surgery educational events. Today’s topic focuses on the racial distribution of patients in U.S. clinical trials. Again, there is clearly an imbalance between the U.S. population demographics and the subjects who participate in U.S. clinical trials.
My review of U.S. census data suggests that 60.1% of our population considers themselves white, 18.5% Hispanic/Latino, 13.4% Black/African American, 5.9% Asian and 1% each Native American, Alaskan American and Pacific Islander. To make it even more complex, the racial demographics vary state to state. I was born and practiced primarily in Minnesota. In Minnesota, 83.3% of our citizens consider themselves white and only 1.7% Hispanic/Latino. I owned a second home in Hawaii for 10 years. In Hawaii, 37.6% consider themselves Asian, only 25% white and 10% Pacific Islander. My current second home is in California, where the majority, 39%, designate themselves as Hispanic/Latino, 37% white and 15% Asian.
My clinical experience and the literature confirm that different races do not respond to pharmaceuticals, biologics or even surgical procedures the same. As physicians, we all want to know as much as possible how an individual patient will respond to a proposed treatment. We are all motivated to provide personalized and appropriate eye care.
This issue’s cover story confirms that our U.S.-based clinical trials that lead to publications about and/or FDA approval of drugs, biologics and devices are dominated by white subjects. This is a major issue in more than one way. Social justice demands that we share the benefits and risks of any activity equally among our citizens. This data suggest that the U.S. white citizen is bearing a greater risk in subjecting themselves to the unknown risks of investigational treatments, but they are also reaping a superior benefit once a new therapeutic is approved as the practicing clinician can more accurately inform a white patient regarding the risks and potential benefits of a proposed therapy.
Once again, recognizing the inequity and lack of social justice in this situation is easier than the remedy. All companies, institutions and investigators who plan and pursue prospective clinical trials and our citizens would benefit from having an appropriately diverse clinical trial patient population. But recruiting such a diverse study population in an efficient, fair, inclusive, equitable, timely and affordable manner remains a significant challenge.
As I have written before, recognizing a lack of diversity, equity, inclusion or social justice in any situation is the first step in resolving the issue. It is in our fellow American citizens’ and we physicians’ best interests to do our best to recruit a diverse patient population in every clinical trial. We must and can do better.
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