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.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• PLANNING COMMITTEE ON SHARING CLINICAL TRIAL DATA: CHALLENGES AND A WAY FORWARD
• FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
• FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS
• NATIONAL CANCER POLICY FORUM
• ROUNDTABLE ON GENOMICS AND PRECISION HEALTH
• Reviewers
• Acknowledgments
• Acronyms and Abbreviations
• 1. Introduction
  • REVISITING THE 2015 INSTITUTE OF MEDICINE CONSENSUS STUDY REPORT SHARING CLINICAL TRIAL DATA: MAXIMIZING BENEFITS, MINIMIZING RISK
  • PROGRESS MADE IN CLINICAL TRIAL DATA SHARING SINCE THE 2015 INSTITUTE OF MEDICINE CONSENSUS STUDY REPORT
  • ORGANIZATION OF THE WORKSHOP AND PROCEEDINGS
• 2. Perspectives on Current Data-Sharing Policies in Practice
  • RESEARCHER PERSPECTIVE
    Harlan Krumholz, Harold H. Hines Jr. Professor of Medicine.
  • PATIENT PERSPECTIVE
    Moses Taylor, Jr., Participant.
  • INDEPENDENT REVIEW PANEL PERSPECTIVE
    Sonali Kochhar, Medical Director.
  • FUNDER PERSPECTIVE
    Lyric Jorgenson, Deputy Director.
• 3. Data-Sharing Platforms
  • VIVLI
    Rebecca Li, Executive Director.
  • THE YODA PROJECT
    Joseph Ross, Professor of Medicine and Public Health.
  • SOAR
    Frank Rockhold, Professor of Biostatistics and Bioinformatics.
  • CLINICALSTUDYDATAREQUEST.COM
    Scott Shaunessy, Co-Founder and Chair.
• 4. Striking a Balance Between Benefit/Value and Risk/Cost
  • DATA ANALYST PERSPECTIVE
    David DeMets, Professor Emeritus.
  • PUBLISHER PERSPECTIVE
    Jeffrey M. Drazen, Group Editor.
  • PATIENT PERSPECTIVE
    Deborah Peel, Founder and President.
  • DISCUSSION
• 5. Data Interoperability and Platform Usability
  • WORKING WITH POPULATION DATA
    Ernest Hawk, Vice President and Head.
  • CHALLENGES FOR META-ANALYSIS
    Tianjing Li, Associate Professor.
  • PLATFORM PERSPECTIVE
    Bill Louv, President.
  • DISCUSSION
• 6. Infrastructure Sustainability
  • FUNDER PERSPECTIVE
    Georgina Humphreys, Clinical Data Sharing Manager.
  • INDUSTRY PERSPECTIVE
    Pandurang Kulkarni, Chief Analytics Officer and Vice President of Biometrics and Advanced Analytics.
  • PLATFORM PERSPECTIVE
    Sean Coady, Program Officer.
  • DISCUSSION
• 7. Challenges and Disincentives for Sharing and Reuse of Data
  • RESEARCHER PERSPECTIVE
    Matthew Sydes, Professor of Clinical Trials and Methodology.
  • SPONSOR PERSPECTIVE
    Ramin Daron, Vice President.
  • PATIENT PERSPECTIVE
    Sharon Terry, President and Chief Executive Officer.
  • DISCUSSION
• 8. Finding Value in Sharing Clinical Trial Data: Overcoming Usability and Sustainability Challenges
  • DATA USER PERSPECTIVE
    Mark Helfand, Professor of Medicine, Medical Informatics, and Clinical Epidemiology.
  • DATA GENERATOR/SHARER PERSPECTIVE
    Monica Bertagnolli, Professor of Surgery.
  • PLATFORM PERSPECTIVE
    Rebecca Kush, Chief Scientific Officer.
  • DISCUSSION
• 9. Looking Forward: Incentivizing Data Sharing and Reuse
  • SPONSOR PERSPECTIVE
    Liz Roberts, Senior Director and Global Public Policy Lead.
  • RESEARCHER PERSPECTIVE
    Colin Baigent, Deputy Director.
  • INSTITUTIONAL PERSPECTIVE
    Amy Nurnberger, Program Head of Data Management Services.
  • FUNDER PERSPECTIVE
    Georgina Humphreys, Clinical Data Sharing Manager.
  • DISCUSSION
  • CLOSING REMARKS: FINDING VALUE AS WE MOVE FORWARD
• Appendix A. References
• Appendix B. Workshop Agenda

Suggested citation:

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. https://doi.org/10.17226/25838.

Digital Object Identifier: https://doi.org/10.17226/25838

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