Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop (2020)
Chapter: Appendix B: Workshop Agenda
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Appendix A: References
Appendix B
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Appendix B
Workshop Agenda
Sharing Clinical Trial Data: Challenges and a Way Forward:
A Workshop
November 18–19, 2019
National Academy of Sciences Building, Great Hall
2101 Constitution Avenue, NW, Washington, DC 20418
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
DAY 1: November 18, 2019
| 8:00 a.m. | Breakfast available in the Great Hall |
| 8:30 a.m. | Welcome and opening remarks |
| JEFFREY M. DRAZEN, Workshop Co-Chair | |
| Group Editor | |
| New England Journal of Medicine | |
| JOANNE WALDSTREICHER, Workshop Co-Chair | |
| Chief Medical Officer | |
| Johnson & Johnson |
Session I: The Current Landscape of Clinical Trial Data Sharing and Reuse
Session Objectives:
- Consider the value and potential risks/costs of sharing clinical trial data for key stakeholders, including clinical trialists, sponsors, primary and secondary researchers, and patients
- Review the current landscape of clinical trial data sharing and reuse across public and private sectors (e.g., policies, platforms, collaborations, data sharing culture)
- Examine case studies and trends from across public and private sectors when it comes to success, failure, lessons learned, and value
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
| 9:00 a.m. | Landscape overview by session moderators |
| BERNARD LO | |
| President and Chief Executive Officer | |
| The Greenwall Foundation | |
| DEBORAH ZARIN | |
| Director | |
| Program for the Advancement of the Clinical Trials Enterprise | |
| Multi-Regional Clinical Trials Center | |
| Brigham and Women’s Hospital and Harvard | |
| 9:20 a.m. | Policies in practice: Lessons learned |
| A researcher perspective | |
| HARLAN KRUMHOLZ | |
| Harold H. Hines Jr. Professor of Medicine | |
| Yale School of Medicine | |
| A funder perspective | |
| LYRIC JORGENSON | |
| Deputy Director | |
| Office of Science Policy | |
| National Institutes of Health | |
| An independent review panel perspective | |
| SONALI KOCHHAR | |
| Medical Director | |
| Global Healthcare Consulting | |
| A patient perspective | |
| MOSES TAYLOR, JR. | |
| Participant | |
| SPRINT Trial | |
| 10:20 a.m. | Data sharing platforms: Use cases |
| Vivli | |
| REBECCA LI | |
| Executive Director | |
| Vivli |
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
| The YODA Project | |
| JOSEPH ROSS | |
| Professor of Medicine and Public Health | |
| Yale School of Medicine | |
| SOAR | |
| FRANK ROCKHOLD | |
| Professor of Biostatistics and Bioinformatics | |
| Duke University Medical Center | |
| ClinicalStudyDataRequest.com | |
| SCOTT SHAUNESSY | |
| Chair | |
| ClinicalStudyDataRequest.com | |
| 11:20 a.m. | BREAK |
| 11:50 a.m. | Panel discussion: Striking a balance between benefit/value and risk/cost—is the juice worth the squeeze? |
| A data analyst perspective | |
| DAVID DEMETS | |
| Professor Emeritus | |
| Department of Biostatistics and Medical Informatics | |
| University of Wisconsin–Madison | |
| A publisher perspective | |
| JEFFREY M. DRAZEN | |
| Group Editor | |
| New England Journal of Medicine | |
| A patient perspective | |
| DEBORAH C. PEEL | |
| Founder and President | |
| Patient Privacy Rights | |
| 12:35 p.m. | Moderated audience discussion with the panel |
| 1:00 p.m. | BREAK (Lunch available in the Great Hall) |
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Session II: Key Challenges in Clinical Trial Data Sharing and Reuse
Session Objectives:
- Discuss key challenges to clinical trial data sharing and reuse by including use cases
- Consider the perspectives and expectations of clinical trial participants, patients, research sponsors (pharmaceutical companies and nonprofit organizations), journals, academic researchers and institutions, institutional review boards, and federal agencies
| 1:30 p.m. | Opening remarks by session moderators |
| TIMOTHY COETZEE | |
| Chief Advocacy, Services, and Research Officer | |
| National Multiple Sclerosis Society | |
| DINA PALTOO | |
| Assistant Director | |
| Policy Development | |
| National Library of Medicine | |
| National Institutes of Health | |
| 1:45 p.m. | Panel discussion: Data interoperability and platform usability |
| Use case: Population data | |
| ERNEST HAWK | |
| Vice President and Division Head | |
| Cancer Prevention and Population Sciences | |
| MD Anderson | |
| Use case: Meta-analysis | |
| TIANJING LI | |
| Associate Professor | |
| University of Colorado Denver | |
| A platform perspective | |
| BILL LOUV | |
| President | |
| Project Data Sphere | |
| 2:15 p.m. | Moderated audience discussion with the panel |
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
| 2:45 p.m. | Panel discussion: Infrastructure sustainability |
| A funder perspective | |
| GEORGINA HUMPHREYS | |
| Clinical Data Sharing Manager | |
| Wellcome Trust | |
| A business perspective | |
| PANDURANG KULKARNI | |
| Chief Analytics Officer R&D | |
| Vice President | |
| Biometrics and Advanced Analytics | |
| Eli Lilly and Company | |
| A platform perspective | |
| SEAN COADY | |
| Program Officer | |
| National Heart, Lung, and Blood Institute | |
| National Institutes of Health | |
| 3:15 p.m. | Moderated audience discussion with the panel |
| 3:45 p.m. | BREAK |
| 4:15 p.m. | Panel discussion: Challenges and disincentives for sharing and using data |
| Use case: Statistical replication | |
| A researcher perspective | |
| MATTHEW SYDES | |
| Professor of Clinical Trials and Methodology | |
| Medical Research Council Clinical Trials Unit | |
| University College London | |
| A sponsor perspective | |
| RAMIN DARON | |
| Vice President, Data Architecture and Technology | |
| Takeda Pharmaceuticals | |
| A patient perspective | |
| SHARON TERRY | |
| President and Chief Executive Officer | |
| Genetic Alliance |
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
| 4:45 p.m. | Moderated audience discussion with the panel |
| Day 1 Reflections | |
| 5:15 p.m. | Finding value as we move forward |
| JEFFREY M. DRAZEN, Workshop Co-Chair | |
| Group Editor | |
| New England Journal of Medicine | |
| JOANNE WALDSTREICHER, Workshop Co-Chair | |
| Chief Medical Officer | |
| Johnson & Johnson | |
| 5:30 p.m. | ADJOURN WORKSHOP DAY 1 |
DAY 2: November 19, 2019
| 8:00 a.m. | Breakfast available in the Great Hall |
| 8:30 a.m. | Welcome and overview of Day 1 |
| JEFFREY M. DRAZEN, Workshop Co-Chair | |
| Group Editor | |
| New England Journal of Medicine | |
| JOANNE WALDSTREICHER, Workshop Co-Chair | |
| Chief Medical Officer | |
| Johnson & Johnson |
Session III: Finding Value in Sharing Clinical Trial Data
Session Objectives:
- Discuss next step opportunities for stakeholders to better align incentives, and implement policy, technology, and governance that encourage the sharing and reuse of clinical trial data:
- Explore opportunities for overcoming technical barriers
- Explore opportunities for addressing cultural barriers
- Discuss possible solutions/next steps going forward
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
| 8:45 a.m. | Panel discussion: Overcoming usability and sustainability challenges |
| Moderator | |
| IDA SIM | |
| Professor of Medicine | |
| University of California, San Francisco, School of Medicine | |
| A data user perspective | |
| MARK HELFAND | |
| Professor of Medicine, Medical Informatics, and Clinical Epidemiology | |
| Oregon Health & Science University | |
| A data generator/sharer perspective | |
| MONICA BERTAGNOLLI | |
| Professor of Surgery | |
| Harvard Medical School | |
| A platform perspective | |
| REBECCA KUSH | |
| Chief Scientific Officer | |
| Elligo Health Research | |
| 9:30 a.m. | Moderated audience discussion with the panel |
| 10:00 a.m. | BREAK |
| 10:30 a.m. | Panel discussion: Looking forward: Incentivizing data sharing and reuse |
| Moderator and sponsor perspective | |
| LIZ ROBERTS | |
| Senior Director and Global Public Policy Lead | |
| UCB Biosciences | |
| A researcher perspective | |
| COLIN BAIGENT | |
| Deputy Director | |
| Clinical Trial Service Unit and Epidemiological Studies Unit | |
| Oxford University |
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
| An institutional perspective | |
| AMY NURNBERGER | |
| Program Head | |
| Data Management Services | |
| Massachusetts Institute of Technology | |
| A funder perspective | |
| GEORGINA HUMPHREYS | |
| Clinical Data Sharing Manager | |
| Wellcome Trust | |
| 11:45 a.m. | Moderated audience discussion with the panel |
| 12:15 p.m. | Next Steps |
| JEFFREY M. DRAZEN, Workshop Co-Chair | |
| Group Editor | |
| New England Journal of Medicine | |
| JOANNE WALDSTREICHER, Workshop Co-Chair | |
| Chief Medical Officer | |
| Johnson & Johnson | |
| 12:30 p.m. | ADJOURN WORKSHOP DAY 2 |
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
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Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
Suggested Citation:
"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25838.
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