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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.
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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.
×
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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.
×
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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.
×
Page 129
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.
×
Page 130
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.
×
Page 131
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.
×
Page 132
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.
×
Page 133
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.
×
Page 134
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.
×
Page 135
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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On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing. This publication summarizes the presentations and discussions from the workshop.

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