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Diabetic Macular Edema Trials Lack Accurate Patient Racial Representation

A new cross-sectional analysis from ASRS 2021 show White patients are generally overrepresented in randomized, controlled trials for DME.

Patients identified as White are generally overrepresented in diabetic macular edema (DME) randomized controlled trials (RCTs) compared to other patient races and ethnicities, according to a new assessment.

The cross-sectional analysis, presented at the American Society of Retina Specialists (ASRS) 2021 Scientific Meeting this weekend, show a lack of racial representation for patients with DME included in pivotal clinical research for their condition—an issue which could limit the validity and application of randomized, controlled trial findings.

Led by Abdul-Hadi Kaakour, MD, MS, of the Cleveland Clinic, investigators sought to observe the distribution of race in DME randomized control trials comparatively to that of the most recently available US Census data from 2010. As investigators noted, representation is crucial in clinical assessments for a variety of reasons.

“It is important that RCTs represent real world patient populations,” Kaakour and colleagues wrote. “Lack thereof might affect external validity of studies and limit real world applications to underrepresented minorities.”

The teams’ study observed the racial demographics of 15 identified RCTs that included patients with DME, comparing it to the Census data via a chi-square test. They recorded both total numbers and percentages of White, Black, Hispanic, Asian, American Indian/Alaska Native and Native Hawaiian/Pacific Islander trial participants.

Statistical significance was defined by P values <.05.

Kaakour and colleagues noted that White patient cohorts were overrepresented in 10 RCTs compared to US Census data, and underrepresented in only 2 RCTs. Black patient cohorts were overrepresented in just 3 RCTs and underrepresented in 6 RCTs. Hispanic patient cohorts were overrepresented in 3 RCTs and underrepresented in 9 RCTs.

Asian patient cohorts were overrepresented in 3 RCTs and underrepresented in 8 RCTs. The combined American Indian/Alaska Native and Hawaiian/Pacific Islander patient cohorts were not overrepresented in any RCTs, and underrepresented in 4 RCTs.

The investigators confirmed that White patients with DME tend to be overrepresented in RCTs, relative to 2010 US Census data. The lack of proper representation in DME clinical assessments compared to the actual national population is a matter of concern for the true of RCT outcomes.

“More efforts should be made to recruit underrepresented minorities to improve trial external validity and to better serve these populations,” investigators concluded.

The study, “Race Representation in Diabetic Macular Edema Randomized Control Trials Compared to the United States Census Data,” was presented at ASRS 2021.