A Systematic Review and Meta-Analysis Assessing Diversity and Representation in Diabetic Retinopathy Clinical Trials in the U.S.

Purpose: To perform a systematic review and meta-analysis assessing the diversity and representation of diabetic retinopathy (DR) patients in clinical trials conducted in the United States from January 1, 2018, to December 31, 2023. Methods: A comprehensive search strategy was conducted on May 28th, 2024 using MEDLINE (PubMed) and Embase (Elsevier) to identify relevant clinical trials. Inclusion criteria included trials published between January 1, 2018 and December 31, 2023, focusing on interventions for DR that were conducted in the United States. Screening and data extraction were independently performed by three reviewers. Results: Eleven clinical trials met the inclusion criteria and were analyzed for participant representation based on sex, age, and race/ethnicity. Sex representation was rated as good in 9 of the 11 studies. However, age representation was rarely reported (only 1/11 studies) and race/ethnicity representation was poor in 6 of the 11 studies. The findings highlight significant underrepresentation of Asian and Black populations. Conclusion: This study reveals substantial disparities in the demographic representation within DR clinical trials in the United States, emphasizing the critical need for improved inclusion strategies. Enhancing diversity in these trials is essential for producing research findings that are more applicable to the broader population affected by DR, ultimately contributing to more equitable healthcare outcomes and advancing the effectiveness of treatments across diverse demographic groups.