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National Academies Press
Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials: Proceedings of a Workshop

Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials: Proceedings of a Workshop


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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.

Product Details

ISBN-13: 9780309443579
Publisher: National Academies Press
Publication date: 09/24/2016
Pages: 84
Sales rank: 942,011
Product dimensions: 6.00(w) x 9.00(h) x (d)

Table of Contents

Acronyms and Abbreviations xiii

1 Introduction and Highlights of the Workshop 1

Health Disparities and Clinical Trials 2

Origins of the Workshop 3

Highlights of the Workshop 5

Organization of the Proceedings of a Workshop 7

2 Historical Perspectives and Context 9

The Historical and Social Origins of Race 9

The Drawbacks of Mandated Inclusion 11

Historical Perspectives on Meaningful Inclusion 13

Latinos in Clinical Trials 14

The Effects of Precision Medicine 16

3 Scientific Issues: Clinically Meaningful Inclusion 19

Overcoming the Biases of the Research Community 19

Inclusion in Industry Trials 22

Clinical Trials at the Patient-Centered Outcomes Research Institute 25

Increasing Diversity Among Researchers 28

4 Recruitment and Retention Issues: Patient, Provider, Institutional, and System Barriers 29

The Integrity of Research and Clinical Trials 29

Informed Consent and Other Factors 32

Patient Perspectives on Clinical Trials 33

Engaging Communities in HIV Research 35

Immigrant Populations 39

5 Potential Best Practices and Policy Options 41

Potential Best Practices and Policies for Inclusion of Asian Americans into Clinical Trials 41

Potential Best Practices and Policies for Inclusion of Native Americans into Clinical Trials 44

A Cooperative Group Perspective on Potential Best Practices and Policy Options 47

Achieving Diversity Among Researchers 49

Potential Policy Changes 50

References 53


A Workshop Agenda 55

B Speaker Biographical Sketches 59

C Statement of Task 69

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