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Sharing data generated through the conduct of clinical trials offers the promise of placing evidence about the safety and efficacy of therapies and clinical interventions on a firmer basis and enhancing the benefits of clinical trials. Ultimately, such data sharing - if carried out appropriately - could lead to improved clinical care and greater public trust in clinical research and health care.

Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities is part of a study of how data from clinical trials might best be shared. This document is designed as a framework for discussion and public comment. This framework is being released to stimulate reactions and comments from stakeholders and the public. The framework summarizes the committee's initial thoughts on guiding principles that underpin responsible sharing of clinical trial data, defines key elements of clinical trial data and data sharing, and describes a selected set of clinical trial data sharing activities.

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Suggested Citation

Institute of Medicine. 2014. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. Washington, DC: The National Academies Press. https://doi.org/10.17226/18610.

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Publication Info

72 pages |  6 x 9 | 

ISBNs: 
  • Paperback:  978-0-309-29779-0
  • Ebook:  978-0-309-29782-0
DOI: https://doi.org/10.17226/18610
Chapters skim
Front Matter i-xiv
Discussion Framework for Clinical Trial Data Sharing 1-36
References 37-42
Appendix A: Statement of Task 43-44
Appendix B: Committee Biographies 45-56
Appendix C: Figure 1: Data Flow from Participant to Analyzed Data and Reporting 57-58

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