Reporting and enrollment of women and racial minorities in ophthalmic clinical trials

Purpose: Studies have shown under-enrollment women and racial minorities in clinical trials for heart failure, stroke, and cancer, but no such studies exist in ophthalmology. It is essential that sex and minority groups be adequately represented to ensure that results generated from clinical trials have external validity. This study examines 1) patterns in the reporting of women and racial minority enrollment, and 2) the rates of enrollment of women and racial minorities in ophthalmic clinical trials. Methods: A literature search to identify federally and privately supported phase III and IV clinical trials taking place in the United States and published between 1993-2017 (n =108 studies) was performed in July 2017 using (1 ) US National Library of Medicine Clinical Trials database on Clinicaltrials.gov and (2) Pubmed using search criteria for ophthalmology and Clinical Trial. Publications reporting data on demographic categories: sex, age, and race were documented. Enrollment rates by sex and race subgroup were documented. A chi-squared test was performed to compare these results before and after January 1, 2011, when the National Institute on Minority Health and Health Disparities was established to improve policies around health disparities in research. Results: From 1993-2017, 83.3% of trials reported on sex, 88.9% on age, and 68.5% on race with all reporting increasing over time (p=0.003, p=0.03, p=0.0001, respectively). Most subjects were women (54%) and White (81.4%). Clinical trials reporting on racial minorities overall was 41.7% for Blacks, 32.4% for Asians, and 27.8% for Latinos/Hispanics and it also increased over time (p=0.0001, p=0.0001, p=0.003, respectively). In those trials conducted after 2011, enrollment signi-cantly increased for women (53% vs 55%, p\u3c0.0001), Asians (1.6% vs 5.1%, p\u3c0.0001 ), and Hispanics/Latinos (9.1 % vs 12.7%, p\u3c0.0001 ), but there was no change in White or Black enrollment over time. Conclusions: Ophthalmic clinical trials are increasingly reporting all demographic categories and improving enrollment for some, but not all demographic categories. Continued awareness of the importance of enrolling racial minorities in ophthalmic clinical trials and interventions to improve recruitment of some groups are needed