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
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
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 |
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) |
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 |
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 |
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
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 |
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 |
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