Gender and Ethnicity of Enrolled Participants in U.S. Food and Drug Administration (FDA) Clinical Trials for Approved Ophthalmological New Molecular Entities

Abstract

Purpose: The purpose of this review is to describe the demographics (age, gender, race and iris color) of subjects enrolled in clinical trials supportive of approved New Molecular Entities (NMEs) in ophthalmology over the last 10 years (2006-2016).

Methods: Publicly available data on Drugs@FDA were reviewed for all 9 approved NMEs, including biologics, from 2006 to 2016.

Results: All NMEs have publicly available data on the race, gender and age of clinical trial participants. Women and white subjects comprise a majority of clinical trial participants (68% and 92%, respectively). FDA analyses on all 9 NMEs did not find any differences across age, gender, race, or iris color subgroups.

Keywords: Clinical trials; Gender; Ophthalmology; Race.