Minority enrollment still low in ophthalmic clinical trials after Final Rule implemented
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Race and ethnicity disclosures in clinical trials increased significantly after implementation of the Final Rule, but no progress was seen in the enrollment of minority groups, according to a poster presentation at Real World Ophthalmology.
The Final Rule for Clinical Trials Registration and Results Information Submission was issued by the Department of Health and Human Services in 2016 to clarify and expand the requirements for data that must be submitted to ClinicalTrials.gov. These include information on participants’ race and ethnicity, which were typically underreported in ophthalmic clinical trials.
A search conducted on ClinicalTrials.gov on 558 trials completed before and 314 trials completed after implementation of the Final Rule showed that the race disclosure rate increased from 26.16% pre-requirement to 84.39% post-requirement. The ethnicity disclosure rate similarly increased from 16.85% to 55.73%.
However, there was no significant change in enrollment of minorities before and after the requirements. After implementation of the Final Rule, enrollment of white subjects remained higher and enrollment of Hispanic subjects remained lower in trials that were not funded by the NIH as compared with NIH-funded trials.
“Stronger legislation that requires enrollment of minority groups and subsequent demographic information reporting, independent of sponsor type and coupled with thorough monitoring of compliance, should be considered to improve diversity in ophthalmic clinical trials,” the authors wrote.
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Goodman D, et al. Demographic disclosure rate and enrollment before and after the Final Rule in ophthalmic clinical trials. Presented at: Real World Ophthalmology; Sept. 30, 2023 (virtual meeting).
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