STRATEGIES FOR ENSURING
DIVERSITY, INCLUSION,
AND MEANINGFUL
PARTICIPATION
IN CLINICAL TRIALS
Proceedings of a Workshop
Karen M. Anderson and Steve Olson, Rapporteurs
Roundtable on the Promotion of Health Equity
and the Elimination of Health Disparities
Board on Population Health and Public Health Practice
Health and Medicine Division
THE NATIONAL ACADEMIES PRESS
Washington, DC
THE NATIONAL ACADEMIES PRESS500 Fifth Street, NWWashington, DC 20001
This activity was supported by the Aetna Foundation, Health Resources and Services Administration, Kaiser Permanente, The Kresge Foundation, Merck & Co., Inc., Methodist Health Ministries, and Office of Minority Health, U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-44357-9
International Standard Book Number-10: 0-309-44357-1
Digit Object Identifier: 10.17226/23530
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Copyright 2016 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. Strategies for ensuring diversity, inclusion, and meaningful participation in clinical trials: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: 10.17226/23530.
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PLANNING COMMITTEE ON STRATEGIES FOR ENSURING DIVERSITY, INCLUSION, AND MEANINGFUL PARTICIPATION IN CLINICAL TRIALS1
JONCA BULL (Chair), Director of the Office of Minority Health, U.S. Food and Drug Administration
DEIDRE CREWS, Associate Professor of Medicine in the Division of Nephrology, Johns Hopkins University School of Medicine, and Associate Vice Chair for Diversity and Inclusion in the Department of Medicine
IRENE DANKWA-MULLAN, Deputy Director and Medical Officer, National Institute on Minority Health and Health Disparities, National Institutes of Health
FRANCISCO GARCÍA, Director and Chief Medical Officer, Pima County Department of Health
ALLAN GOLDBERG, Leader of U.S. Academic and Professional Affairs, Merck & Co., Inc.
CHAZEMAN JACKSON, Health Science Advisor, Office of Minority Health, U.S. Department of Health and Human Services2
ROHIT VARMA, Grace and Emery Beardsley Professor and Chair, University of Southern California
TONI VILLARRUEL, Professor and Margaret Bond Simon Dean of Nursing, University of Pennsylvania
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
2 This has been updated since publication.
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ROUNDTABLE ON THE PROMOTION OF HEALTH EQUITY AND THE ELIMINATION OF HEALTH DISPARITIES1
ANTONIA M. VILLARRUEL (Chair), University of Pennsylvania
PATRICIA BAKER, Connecticut Health Foundation
GILLIAN BARCLAY, Aetna Foundation
NED CALONGE, The Colorado Trust
FRANCISCO GARCÍA, Pima County Department of Health
ALLAN GOLDBERG, Merck & Co., Inc.
J. NADINE GRACIA, U.S. Department of Health and Human Services
JEFFREY A. HENDERSON, Black Hills Center for American Indian Health
EVE J. HIGGINBOTHAM, University of Pennsylvania
CARA V. JAMES, Centers for Medicare & Medicaid Services
OCTAVIO MARTINEZ, Hogg Foundation for Mental Health
NEWELL MCELWEE, Merck & Co., Inc.
PHYLLIS W. MEADOWS, The Kresge Foundation
CHRISTINE RAMEY, Health Resources and Services Administration
MELISSA SIMON, Northwestern University Feinberg School of Medicine
PATTIE TUCKER, Centers for Disease Control and Prevention
UCHE UCHENDU, Veterans Health Administration, Office of Health Equity
ROHIT VARMA, University of Illinois–Chicago
WINSTON F. WONG, Kaiser Permanente
TERRI D. WRIGHT, American Public Health Association
Health and Medicine Division Staff
KAREN M. ANDERSON, Senior Program Officer
ROSE MARIE MARTINEZ, Senior Board Director
ANNA MARTIN, Senior Program Assistant
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
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Reviewers
This Proceedings of a Workshop has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published Proceedings of a Workshop as sound as possible and to ensure that the Proceedings of a Workshop meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this Proceedings of a Workshop:
Kathleen A. Curran, Catholic Health Association of the United States
Elizabeth Ofili, Morehouse School of Medicine
Leshawndra N. Price, National Institute on Mental Health
Yolanda Savage-Narva, Association of State and Territorial Health Officials
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the Proceedings of a Workshop before its release. The review of this Proceedings of a Workshop was overseen by David R. Challoner, University of Florida. He was responsible for making certain that an independent examination of this Proceedings of a Workshop was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this Proceedings of a Workshop rests entirely with the rapporteurs and the institution.
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Contents
1 INTRODUCTION AND HIGHLIGHTS OF THE WORKSHOP
Health Disparities and Clinical Trials
Organization of the Proceedings of a Workshop
2 HISTORICAL PERSPECTIVES AND CONTEXT
The Historical and Social Origins of Race
The Drawbacks of Mandated Inclusion
Historical Perspectives on Meaningful Inclusion
The Effects of Precision Medicine
3 SCIENTIFIC ISSUES: CLINICALLY MEANINGFUL INCLUSION
Overcoming the Biases of the Research Community
Clinical Trials at the Patient-Centered Outcomes Research Institute
4 RECRUITMENT AND RETENTION ISSUES: PATIENT, PROVIDER, INSTITUTIONAL, AND SYSTEM BARRIERS
The Integrity of Research and Clinical Trials
Informed Consent and Other Factors
Patient Perspectives on Clinical Trials
Engaging Communities in HIV Research
5 POTENTIAL BEST PRACTICES AND POLICY OPTIONS
Potential Best Practices and Policies for Inclusion of Asian Americans into Clinical Trials
Potential Best Practices and Policies for Inclusion of Native Americans into Clinical Trials
A Cooperative Group Perspective on Potential Best Practices and Policy Options
Achieving Diversity Among Researchers
Acronyms and Abbreviations
| ATN | Adolescent Medicine Trials Network for HIV/AIDS Interventions |
| AZT | azidothymidine |
| FDA | U.S. Food and Drug Administration |
| IOM | Institute of Medicine |
| IRB | institutional review board |
| NCI | National Cancer Institute |
| NIH | National Institutes of Health |
| NRC | National Research Council |
| PCORI | Patient-Centered Outcomes Research Institute |
| PhRMA | Pharmaceutical Research and Manufacturers of America |
| STD | sexually transmitted disease |
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