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 | |
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 |
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 | |
Director, Cancer Health Equity Institute | |
Morehouse School of Medicine |
MATTHEW WATLEY | |
Senior Pastor | |
Kingdom Fellowship AME Church | |
KARRIEM WATSON | |
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 | |
Office of Oncologic Diseases | |
Food and Drug Administration |
U. MICHAEL CURRIE | |
Health Care Consultant | |
STEPHEN KONYA | |
Senior Advisor to the Deputy National Coordinator | |
Innovation Portfolio Lead | |
Office of the National Coordinator for Health Information Technology | |
SARAH HUDSON SCHOLLE | |
Principal | |
Leavitt Partners | |
VINDELL WASHINGTON | |
Chief Clinical Officer | |
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 | |
Director of Policy Research | |
National Association of Community Health Centers |
KRISTEN NWANYANWU | |
Associate Professor of Ophthalmology and Visual Science | |
Yale School of Medicine | |
JONI RUTTER | |
Director, National Center for Advancing Translational Sciences | |
National Institutes of Health | |
CHERYL WILLMAN | |
Executive Director, Cancer Programs | |
Director, Mayo Clinic Comprehensive Cancer Center | |
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 | |
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 | |
Pharmaceutical Research and Manufacturers of America | |
NATALIA CHALMERS | |
Chief Dental Officer | |
Centers for Medicare & Medicaid Services | |
GWEN DARIEN | |
Executive Vice President, Patient Advocacy, Engagement, and Education | |
Patient Advocate Foundation | |
DECHANE DORSEY | |
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 |
