Nonwhite patients underrepresented in DME trials
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FORT LAUDERDALE, Fla. — Despite efforts to promote more diverse patient populations, racial minority patient groups are underrepresented in diabetic macular edema trials, according to a study.
In a presentation at the Retina World Congress, Jay Chhablani, MD, said The NIH Revitalization Act of 1993 mandated the inclusion of racial minority groups and women in clinical trials. However, only a small amount of trials have enrolled a sufficient amount of patients from minority groups or reported outcomes by race.
“Nonwhite racial and ethnic subgroups are frequently underrepresented in clinical trials,” he said. “We wanted to understand this in ophthalmology, and we wanted to see how much of our clinical trials are transparent.”
Researchers looked at clinical trials for DME conducted from 2002 to 2021 and compared their study populations with census demographic data as well as the CDC’s 2020 National Diabetes Statistics Report’s demographic data on patients diagnosed with diabetes.
Chhablani and colleagues found that there was an increase in race reporting from the first decade of the study to the second. There was also a decrease in white patient enrollment and increases in Asian and Hispanic patient enrollment. There was no significant change in enrollment among all other races.
Compared with the proportion of Hispanic members of the U.S. population, Hispanic patients appeared to be underrepresented in total participant enrollment, Chhablani said. Additionally, compared with demographics of patients diagnosed with diabetes, Black, Asian and Hispanic patients were all underrepresented in total participant enrollment.
Chhablani said the clinical trial screening process and study criteria might contribute to the underrepresentation of these groups.
“We believe that we need to consider participant enrollment and demographics,” Chhablani said.
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Chhablani J. Racial and ethnic distribution in diabetic macular edema clinical trials in the United States (2002-2021). Presented at: Retina World Congress; May 9-12, 2024; Fort Lauderdale, Florida.
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