U.S. racial and ethnic participation in global clinical trials by therapeutic areas

Author:

Lolic Milena1ORCID,Araojo Richardae1,Okeke Melvyn2,Temple Robert3

Affiliation:

1. Office of the Commissioner US Food and Drug Administration Silver Spring Maryland USA

2. Center for Biologic Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference13 articles.

1. U.S. Food and Drug Administration.Drug trials snapshots. Available at:https://www.fda.gov/drugs/drug‐approvals‐and‐databases/drug‐trials‐snapshots. Accessed March 4 2021.

2. US Census Bureau Population DivisionAnnual estimates of the resident population by sex race and hispanic origin for the United States: April 1 July 1 2019 (NC‐EST2019‐SR11H) Release Date: June 2020.https://www.census.gov/data/datasets/time‐series/demo/popest/2010s‐national‐detail.html.Accessed July 2 2021.

3. US Food and Drug Administration.Collection of race and ethnicity data in clinical trials guidance for industry and food and drug administration staff. Available at:https://www.fda.gov/media/75453/download. Accessed July 2 2021.

4. The Editors.Clinical trials have far too little racial and ethnic diversity. Scientific American.https://www.scientificamerican.com/article/clinical‐trials‐have‐far‐too‐little‐racial‐and‐ethnic‐diversity. Accessed March 9 2021.

5. Inclusion, Analysis, and Reporting of Sex and Race/Ethnicity in Clinical Trials: Have We Made Progress?

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