Study highlights racial, ethnic underrepresentation in retina randomized clinical trials

November 08, 2022

1 min read

Disclosures:
Kaakour reports receiving personal fees from Alimera Sciences outside the submitted work. Please see the study for all other authors’ relevant financial disclosures.

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The demographic distribution of race and ethnicity in most randomized clinical trials does not reflect that of the U.S. population, according to a cross-sectional retrospective analysis.

The study authors focused on diabetic macular edema and retinal vein occlusion in their search of PubMed and ClinicalTrials.gov to identify phase 3 randomized clinical trials (RCTs) conducted in the U.S. between 2004 and 2020. Twenty-three trials were included, and the number and percentage of different races and ethnicities were recorded. The demographic distribution in the studies was then compared with the demographic distribution in the 2010 Census.

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The demographic distribution of race and ethnicity in most randomized clinical trials does not reflect that of the U.S. population, according to a cross-sectional retrospective analysis.
Source: Adobe Stock.

Of the 9,924 total participants, 38 (0.4%) were American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander, 415 (4.4%) were Asian, 904 (9.6%) were Black, 954 (10.1%) were Hispanic and 7,613 (80.4%) were white. These numbers and percentages were out of proportion to the racial and ethnic composition of the U.S. population according to the 2010 Census, in which 1.1% of the U.S. population self-reported as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander, 4.8% as Asian, 12.6% as Black or African American, 16.3% as Hispanic and 63.7% as white.

The authors expressed concern that underrepresenting minorities in studies might contribute to continued health care disparities.

“To provide evidence-based care, it is important that RCTs strive to represent real-world populations. Poor representation may affect the external validity of studies and limit applications to underrepresented sociodemographic minorities,” they wrote.

The need for increased diversity and racial representation in RCTs evaluating retinal diseases is of special significance because studies have shown that specific racial and ethnic groups are at a higher risk to develop certain retinal conditions.

“These findings support the need for more efforts to recruit underrepresented minority groups, which could improve the generalizability of RCT results and in turn help address health care disparities and better serve diverse populations,” the authors said.

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