Toward a Framework to Improve Diversity and Inclusion in Clinical Trials: Proceedings of a Workshop (2025)
Chapter: Appendix A: Workshop Agenda
Appendix A
Workshop Agenda
TOWARD A FRAMEWORK TO IMPROVE DIVERSITY AND INCLUSION IN CLINICAL TRIALS A WORKSHOP
National Academy of Sciences Building, 2101 Constitution Ave, NW Washington, DC 20418
MAY 20, 2024
WELCOME AND OPENING REMARKS
| 8:30 am |
FREDA LEWIS-HALL, Workshop Chair |
|
Former Executive Vice President and Chief Medical Officer (Retired) |
|
|
Pfizer |
|
|
VICTOR DZAU |
|
|
President |
|
|
National Academy of Medicine |
NATIONAL ACTION PLAN OVERVIEW
| 8:40 am |
BARBARA BIERER |
|
Faculty Director, Multi-Regional Clinical Trials Center |
|
|
Professor of Medicine |
|
|
Harvard Medical School and Bringham and Women’s Hospital |
|
|
MORGAN HANGER |
|
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Executive Director |
|
|
Clinical Trials Transformation Initiative |
PANEL 1: STRATEGIES FOR EQUITABLE PARTICIPATION IN CLINICAL TRIALS
Session Objectives:
- Highlight strategies for equitable participation in clinical trials, including innovative trial designs and methodologies, nontraditional clinical trial sites, and community-based partnerships.
- Discuss collaborative approaches to increase relevance, impact, and ease of enrollment for clinical trial participants, while also minimizing the burden of engagement for those conducting the trials.
- Explore collective approaches to overcome barriers to equitable and representative clinical trial participation.
| 9:00 am |
Panel Discussion with Audience Q&A |
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Moderator: Martin Mendoza, Centers for Medicare & Medicaid Services |
|
|
RALPH CAMMACK |
|
|
Director of Research |
|
|
Wabanaki Public Health and Wellness |
|
|
QUITA HIGHSMITH |
|
|
Vice President and Chief Diversity Officer |
|
|
Genentech |
|
|
BRIAN RIVERS |
|
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Director, Cancer Health Equity Institute |
|
|
Morehouse School of Medicine |
|
MATTHEW WATLEY |
|
|
Senior Pastor |
|
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Kingdom Fellowship AME Church |
|
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KARRIEM WATSON |
|
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Chief Engagement Officer |
|
|
All of Us Research Program |
|
|
National Institutes of Health |
|
| 10:00 am |
Coffee Break |
FIRESIDE CHAT: CENTERS FOR MEDICARE & MEDICAID SERVICES
| 10:15 am |
SHARI LING |
|
Deputy Chief Medical Officer |
|
|
Centers for Medicare & Medicaid Services |
|
|
ESTHER KROFAH, Moderator |
|
|
Executive Vice President, Health |
|
|
Milken Institute |
PANEL 2: DEFINING, COLLECTING, AND SHARING DATA ON TRIAL DIVERSITY
Session Objectives:
- Highlight key components of national, interoperable, and accountable systems for collecting and sharing condition-specific demographic data.
- Explore collaborative approaches to collect and share clinical trial data across organizations and sectors to enable continuous learning and improvement in trial diversity.
| 11:00 am |
Panel Discussion with Audience Q&A |
|
Moderator: Carla Rodriguez-Watson, Reagan-Udall Foundation for FDA |
|
|
JAMIE BREWER |
|
|
Medical Oncologist and Clinical Team Lead |
|
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Office of Oncologic Diseases |
|
|
Food and Drug Administration |
|
U. MICHAEL CURRIE |
|
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Health Care Consultant |
|
|
STEPHEN KONYA |
|
|
Senior Advisor to the Deputy National Coordinator |
|
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Innovation Portfolio Lead |
|
|
Office of the National Coordinator for Health Information Technology |
|
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SARAH HUDSON SCHOLLE |
|
|
Principal |
|
|
Leavitt Partners |
|
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VINDELL WASHINGTON |
|
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Chief Clinical Officer |
|
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Director of Health Equity Center of Excellence |
|
|
Verily Communications |
|
| 12:00 pm |
Lunch |
PANEL 3: CLINICAL TRIAL SITE ENABLEMENT
Session Objectives:
- Consider ways to enable established and developing sites—including community-based practices—to increase capacity to conduct more equitable and representative clinical trials.
- Explore business plans and funding mechanisms that promote site enablement and advance equity in clinical trials.
- Discuss cross-sector opportunities for workforce development to support clinical trial site development.
| 12:45 pm |
Panel Discussion with Audience Q&A |
|
Moderator: Kathy Mickel, Society for Clinical Research Sites |
|
|
MEGAN COYLEWRIGHT |
|
|
Vice Chief of Cardiology |
|
|
Erlanger Health System |
|
|
AMY FLOWERS |
|
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Director of Policy Research |
|
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National Association of Community Health Centers |
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KRISTEN NWANYANWU |
|
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Associate Professor of Ophthalmology and Visual Science |
|
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Yale School of Medicine |
|
|
JONI RUTTER |
|
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Director, National Center for Advancing Translational Sciences |
|
|
National Institutes of Health |
|
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CHERYL WILLMAN |
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Executive Director, Cancer Programs |
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Director, Mayo Clinic Comprehensive Cancer Center |
|
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Mayo Clinic |
FIRESIDE CHAT: FOOD AND DRUG ADMINISTRATION AND NATIONAL INSTITUTES OF HEALTH
| 1:45 pm |
MONICA BERTAGNOLLI |
|
Director |
|
|
National Institutes of Health |
|
|
ROBERT CALIFF |
|
|
Commissioner of Food and Drugs |
|
|
Food and Drug Administration |
|
|
NAMANDJÉ BUMPUS |
|
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Principal Deputy Commissioner |
|
|
Food and Drug Administration |
|
| FREDA LEWIS-HALL, Workshop Chair | |
| 2:45 pm |
Coffee Break |
PANEL 4: CHALLENING THE CLINICAL TRIAL ECOSYSTEM
Session Objectives:
- Explore practical and implementable approaches for collaboration across organizations and sectors to advance more equitable and representative participation in clinical trials.
- Consider collective strategies for scaling and sustaining proven approaches for enabling more diverse and inclusive clinical trials.
- Discuss collaborative opportunities for improving public awareness about the risks, benefits, and value of clinical trial participation.
| 3:20 pm |
Panel Discussion with Audience Q&A |
|
Moderator: Michelle McMurry-Heath, BioTechquity Clinical |
|
|
STACEY ADAM |
|
|
Vice President, Science Partnerships |
|
|
Foundation for the National Institutes of Health |
|
|
MARY NWOKEDI-NWANERI |
|
|
Director, Diversity in Clinical Trials |
|
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Pharmaceutical Research and Manufacturers of America |
|
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NATALIA CHALMERS |
|
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Chief Dental Officer |
|
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Centers for Medicare & Medicaid Services |
|
|
GWEN DARIEN |
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Executive Vice President, Patient Advocacy, Engagement, and Education |
|
|
Patient Advocate Foundation |
|
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DECHANE DORSEY |
|
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Executive Director, AdvaMed Accel |
|
|
AdvaMed |
|
|
MARY THANH HAI |
|
|
Deputy Director for Clinical, Office of New Drugs |
|
|
Center for Drug Evaluation and Research |
|
|
Food and Drug Administration |
|
| 4:50 pm |
Closing Remarks |
|
FREDA LEWIS-HALL, Workshop Chair |
|
| 5:00 pm |
Adjourn Workshop |
