Sharing Clinical Trial Data: Challenges and a Way Forward - A Workshop

When: November 18, 2019 - November 19, 2019 (8:30 AM Eastern)
Where: National Academy of Sciences Building (Great Hall) • 2101 Constitution Avenue, NW, Washington, DC 20418

Topic Biomedical and Health Research
Activity: Forum on Drug Discovery, Development, and Translation
Board: Board on Health Sciences Policy

Sharing  Clinical Trial Data: Challenges and a Way Forward

A Workshop

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WORKSHOP ▪ November 18–19, 2019 


Workshop Background and Format

An ad hoc planning committee under the auspices of the National Academies of Sciences, Engineering, and Medicine, planned and conducted a two-day public workshop to discuss advances, challenges, and opportunities in clinical trial data sharing efforts since the release of the 2015 Institute of Medicine report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. This workshop was co-sponsored by the Wellcome Trust.


  • 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);
  • Examine use cases and trends from across public and private sectors when it comes to success, failure, lessons learned, and value;
  • Consider the perspectives and expectations of primary and secondary researchers, clinical trial participants, patient organizations, research sponsors (pharmaceutical companies and nonprofit organizations), journals, institutions, and federal agencies; and
  • Discuss next step opportunities for stakeholders to better harmonize incentives, policy, data standards, and governance to encourage the sharing and reuse of clinical trial data.

The planning committee organized the workshop, developed the agenda, selected and invited speakers and discussants, and moderated or identified moderators for the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.

Workshop Planning Committee Roster

  • Jeffrey M. Drazen (co-chair), New England Journal of Medicine
  • Joanne Waldstreicher (co-chair), Johnson & Johnson
  • Monica M. Bertagnolli, Harvard University Medical School; Dana Farber Cancer Institute and Brigham and Women’s Hospital
  • Timothy CoetzeeNational Multiple Sclerosis Society
  • Patrick Cullinan, Bluebird Bio
  • Sonali Kochhar, Global Healthcare Consulting; University of Washington, Erasmus MC, University Medical Center
  • Bernard Lo, The Greenwall Foundation
  • Deven McGraw, Ciitizen
  • Dina Paltoo, National Library of Medicine, NIH
  • Liz Roberts, UCB Biosciences, Inc
  • Frank W. Rockhold, Duke Clinical Research Institute
  • Sharon Terry, Genetic Alliance
  • Deborah A. Zarin, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

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