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Reflections on Sharing Clinical Trial Data Challenges and a Way Forward: Proceedings of a Workshop (2020) / Chapter Skim
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Appendix B: Workshop Agenda
Pages 127-136

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From page 127...
... 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 WORKSHOP OBJECTIVES Following release of the 2015 Institute of Medicine report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks: • 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, published research output)
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From page 128...
... 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)
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From page 129...
... 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.
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From page 130...
... 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
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From page 131...
... 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.
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From page 132...
... 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
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From page 133...
... 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: o Explore opportunities for overcoming technical barriers o Explore opportunities for addressing cultural barriers o Discuss possible solutions/next steps going forward
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From page 134...
... BREAK 10:30 a.m. Panel discussion: Looking forward: Incentivizing data ­ haring s 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
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From page 135...
... 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.
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Key Terms

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  • sponsor perspective
  • reuse session

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  • division head
  • moderated audience
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  • technical barriers

  • joanne waldstreicher
  • officer national
  • data sphere
  • funder perspective
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  • sclerosis society
  • council clinical
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  • college london


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