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Suggested Citation:"Front Matter." 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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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

Image

THE NATIONAL ACADEMIES PRESS

Washington, DC

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Suggested Citation:"Front Matter." 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.
×

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.

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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.

Suggested Citation:"Front Matter." 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.
×

Image

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

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Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org.

Suggested Citation:"Front Matter." 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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Reports document the evidence-based consensus of an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and committee deliberations. Reports are peer reviewed and are approved by the National Academies of Sciences, Engineering, and Medicine.

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For information about other products and activities of the Academies, please visit nationalacademies.org/whatwedo.

Suggested Citation:"Front Matter." 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.
×

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.

Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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.
×

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.

Page viii Cite
Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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.
×

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.

Suggested Citation:"Front Matter." 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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Page xiii Cite
Suggested Citation:"Front Matter." 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.
×

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
Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Page viii Cite
Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Page xiii Cite
Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Even as the U.S. population becomes steadily more diverse, minorities and women remain underrepresented in clinical trials to develop new drugs and medical devices. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations. Federal legislation has sought to increase the representation of minorities and women in clinical trials, but legislation by itself has not been sufficient to overcome the many barriers to greater participation. Only much broader changes will bring about the meaningful participation of all population groups in the clinical research needed to improve health. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April 2015. This publication summarizes the presentations and discussions from the workshop.

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