Gender and Ethnicity of Enrolled Participants in U.S. Food and

J Natl Med Assoc · Oct 2018

Review

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

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). ⋯ 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.

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- Faith A Birnbaum.
- Division of Internal Medicine, Steward Carney Hospital, Tufts School of Medicine, Dorchester, MA, USA and Department of Ophthalmology, Duke University Medical Center, 2351 Erwin Road, Durham, NC 27705, USA. Electronic address: Faith.Birnbaum@duke.edu.
- J Natl Med Assoc. 2018 Oct 1; 110 (5): 473-479.
PurposeThe 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).MethodsPublicly available data on Drugs@FDA were reviewed for all 9 approved NMEs, including biologics, from 2006 to 2016.ResultsAll 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.Copyright © 2017 National Medical Association. Published by Elsevier Inc. All rights reserved.

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

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