Date Approved

2022

Degree Type

Open Access Thesis

Degree Name

Master of Science (MS)

Department or School

Health Sciences

Committee Member

Michael Switzer, Ph.D., Chair

Committee Member

Jean Rowan, MD, MS

Abstract

Drug development is a rigorous and expensive process that takes between 10 and15 years. Recruitment and retention of human subjects in clinical trials is challenging. This study collected the demographics of trial participant in trials for New Molecular Entities (NMEs) approved by the U.S. Food Drug Administration (FDA) for 2010 and 2020 to compare demographic representation. Demographic representation of trial participants for 61 FDA-approved NMEs for 2010 and 2020 were gathered; 21 NMEs were excluded from analysis. The trends in demographic representation in trials for the 40 FDA-approved NMEs in 2010 and 2020 were similar, and White participant representation was higher than racial/ethnic minorities. This study was limited by inconsistent reporting of demographic categories such as age and ethnic groups. Recruitment of racial/ethnic minorities remains persistently low, which affects the diversity of drug development programs. There is a compelling need for further research.

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