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Suggested Citation:"Appendix A: Workshop Agenda." 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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Appendix A

Workshop Agenda

APRIL 9, 2015

Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials

8:30–8:45 a.m.

Welcome and Overview

Victor Dzau, M.D.

President, National Academy of Medicine

Antonia M. Villarruel, Ph.D.

Roundtable Chair

Dean, College of Nursing, University of Pennsylvania

Jonca Bull, M.D.

Director, Office of Minority Health, U.S. Food and Drug Administration (FDA)

8:45–10:15 a.m.

Panel 1: Historical Perspectives and Context

Moderator: Chazeman Jackson, Ph.D., Office of Minority Health, U.S. Department of Health and Human Services

Amelie Ramirez, Dr.P.H.

University of Texas Health Sciences Center

Suggested Citation:"Appendix A: Workshop Agenda." 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.
×

Otis Brawley, M.D., F.A.C.P.

American Cancer Society

Charles Rotimi, Ph.D.

National Institutes of Health (NIH)

10:15–10:30 a.m. BREAK
10:30 a.m.–12:00 p.m.

Panel 2: Scientific Issues: Clinically Meaningful Inclusion

Moderator: Allan Goldberg, M.D., Merck & Co., Inc.

Objectives:

  • Study design adequacy for subpopulation analyses and outcomes
  • Inclusion/exclusion criteria that results in unintentional bias against some populations
  • Research designs that are relevant to diverse populations and subpopulation analyses

    Dave Hickam, M.D., M.P.H.

    Patient-Centered Outcomes Research Institute

    Jocelyn Ulrich, M.P.H., R.A.C.

    Pharmaceutical Research and Manufacturers of America

    Carol Horowitz, M.D., M.P.H.

    Mount Sinai

12:00–1:00 p.m. LUNCH
1:00–2:30 p.m.

Panel 3: Recruitment and Retention Issues: Patient, Provider, Institutional, and System Barriers

Moderator: Deidra Crews, M.D., S.C.M., Gilbert S. Omenn Anniversary Fellow of the Institute of Medicine, Johns Hopkins University

Objectives:

  • Describe barriers to research, including culturally incongruent research designs, inaccessibility of clinical trials locations to diverse communities, inadequate outreach, and legal status
  • Community engagement in clinical trials research
Suggested Citation:"Appendix A: Workshop Agenda." 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.
×

Connie Ulrich, Ph.D., R.N., F.A.A.N.

University of Pennsylvania

Jonathan Ellen, M.D.

Johns Hopkins All Children’s Hospital

Moon Chen, Ph.D., M.P.H.

University of California, Davis

2:30–2:45 p.m. BREAK
2:45–4:15 p.m.

Panel 4: Best Practices and Policy Recommendations

Moderator: Francisco García, Pima County Health Department

Karen Kim, M.D.

University of Chicago

Teshia Solomon, Ph.D.

University of Arizona

Sandra E. Brooks, M.D., M.B.A.

University of Louisville

4:15–4:45 p.m.

Concluding Reflections

Toni Villarruel, Ph.D., R.N., F.A.A.N.

Roundtable Chair

Barbara Buch, M.D.

FDA

4:45 p.m. ADJOURN
Suggested Citation:"Appendix A: Workshop Agenda." 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:"Appendix A: Workshop Agenda." 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.
×
Page 55
Suggested Citation:"Appendix A: Workshop Agenda." 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.
×
Page 56
Suggested Citation:"Appendix A: Workshop Agenda." 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.
×
Page 57
Suggested Citation:"Appendix A: Workshop Agenda." 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.
×
Page 58
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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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