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Diversity and Inclusion in Ophthalmology Clinical Trials: Overcoming Challenges and Building Trust


Joseph M. Coney, MD, FACS, discusses the importance of diverse representation in clinical trials for the ongoing advancement of safe and effective treatments, and underscores the need for cultivating trust within communities.

Joseph M. Coney, MD, FACS: Randomized clinical trials are the best way we have to assess the efficacy and safety of medications. Unfortunately, historically, individuals from certain communities have not been well represented in clinical trials. There has been a big push for both women and minorities of different races to be included in trials to make sure that the medicines we bring forward to the community are safe and effective. There has been a push to loosen up some of the criteria, which I think are burdens for these trials, particularly when it comes to hemoglobin A1c levels, which historically have limited individuals with diabetic macular edema, from 10% to 12% [of patients]. What this does is capture a larger population of individuals who may not be well controlled. This is a positive step, but those numbers are still dismal compared to what we see in the normal trials. About 90% of all the DNA ancestry in trials is from European ancestry. We have a long way to go in including underserved populations.

The other important part is that while we may be loosening up the criteria for hemoglobin A1c, we are doing similar things for kidney function, high blood pressure, etc, because we know that these indices are greater in certain populations. The problem is, in the real world, individuals are very sick. They have hormonal problems. Oftentimes, these patients are not included in clinical trials for obvious reasons, and I think that’s a good thing. They have kidney disease, they’re on dialysis, they’ve had heart attacks and strokes. We know that when you have diabetic macular edema, these individuals have a higher risk of having [other health problems]. They have a [4-fold increased] chance of seeing a provider, either in an emergency [department], which sometimes becomes their primary provider, or in a hospital or with a primary physician. We know that DME [diabetic macular edema] is a risk factor for other comorbid problems, and these individuals tend to have [more cormorbid] issues, yet they are excluded from clinical trials. However, once the medications are approved, they often receive them. It’s [challenging] when it comes to raising the bar on the individuals you want to see in trials. I know that we all want to have [diverse representation] in trials, and we have the responsibility to do it responsibly, not at the expense of including sicker individuals.

The most important thing is that physicians and trial sites need to have these goals in mind, particularly when it comes to diseases that are very similar and affect that community, [to] at least have a similar makeup. Implicit bias is [a significant reason] why we don’t recruit well. Why did I not talk to Mrs. Johnson, who is Black, about a diabetic trial versus treating her that day, when she qualified for it? The most common reason someone enters a trial is because a physician asks them to, and I think that’s the most important part. We need to be aware of our trials when we ask patients about them, and we need to be candid in figuring out what barriers and burdens they [may face] in clinical trials. Often, clinical trials [are viewed negatively] in the African American community. They are acutely aware of older trials that were unfavorable or that they consider as having racial intent. It’s not their job to get comfortable with that. It’s our job to reach out to the community, break down those barriers, [address] mistrust, and reestablish communication with patients so when it comes time for them to need therapy and you…[offer them a] clinical trial, they are more comfortable with it. The more comfortable they are with you, the more comfortable they may be with being involved in a trial that historically had excluded them or we had not [recruited for really well].

This transcript is AI generated and reviewed by an AJMC® editor.

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