Improving Diversity in Clinical Trials by Using Real-world Data to Define Eligibility Criteria

Author:

Royce Trevor J.12,Zhao Yihua1,Ryals Cleo A.1

Affiliation:

1. Flatiron Health, Inc, New York, New York

2. Department of Radiation Oncology, Wake Forest University School of Medicine, Winston-Salem, North Carolina

Abstract

This Viewpoint discusses the need for thoughtful, modernized eligibility criteria with equity prioritization in clinical trials.

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Reference7 articles.

1. Racial and ethnic disparities among participants in precision oncology clinical studies.;Aldrighetti;JAMA Netw Open,2021

2. Striving for diversity in research studies.;Rubin;N Engl J Med,2021

3. In search of a better equation—performance and equity in estimates of kidney function.;Diao;N Engl J Med,2021

4. Eligibility criteria perpetuate disparities in enrollment and participation of black patients in pancreatic cancer clinical trials.;Riner;J Clin Oncol,2022

5. US Food and Drug Administration. Diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials; draft guidance for industry. April 2022. Accessed April 13, 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations

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