Diversity in clinical trials in Europe and the USA: a review of a pharmaceutical company’s data collection, reporting, and interpretation of race and ethnicity

Author:

Candelario N.M.,Major J.,Dreyfus B.ORCID,Sattler D.,Paulucci D.,Misra S.,Micsinai M.,Kuri L.ORCID

Funder

Bristol-Myers Squibb

Publisher

Elsevier BV

Subject

Oncology,Hematology

Reference14 articles.

1. Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals;Downing;Trials,2016

2. Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry. Silver Spring,2020

3. Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Guidance for Industry (Draft Guidance),2022

4. Revisions to the standards for the classification of federal data on race and ethnicity. [Document no. 97-28653, Published October 30, 1997];Fed Regist,1997

5. Updated guidance on the reporting of race and ethnicity in medical and science journals;Flanagin;JAMA,2021

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