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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.
Contents
- THE NATIONAL ACADEMIES
- COMMITTEE ON STRATEGIES FOR RESPONSIBLE SHARING OF CLINICAL TRIAL DATA
- Reviewers
- Preface
- CONTEXT OF STUDY
- A FRAMEWORK FOR DISCUSSION AND CALL FOR COMMENTS
- GUIDING PRINCIPLES FOR RESPONSIBLE SHARING OF CLINICAL TRIAL DATA
- ADDITIONAL OBSERVATIONS RELATING TO PRINCIPLES FOR DATA SHARING
- DATA SHARING ELEMENTS AND ACTIVITIES
- References
- APPENDIXES
This study was supported by contracts between the National Academy of Sciences and the U.S. National Institutes of Health (HHSN263201200074I), U.S. Food and Drug Administration, AbbVie Inc., Amgen Inc., AstraZeneca Pharmaceuticals, Bayer, Biogen Idec, Bristol-Myers Squibb, Burroughs Wellcome Fund, Doris Duke Charitable Foundation, Eli Lilly and Company, EMD Serono, Genentech, GlaxoSmithKline, Johnson & Johnson, Medical Research Council (UK), Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Takeda, and Wellcome Trust. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.
Suggested citation:
IOM (Institute of Medicine). 2014. Discussion framework for clinical trial data sharing: Guiding principles, elements, and activities. Washington, DC: The National Academies Press.
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
- NLM CatalogRelated NLM Catalog Entries
- Review Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk[ 2015]Review Sharing Clinical Trial Data: Maximizing Benefits, Minimizing RiskCommittee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine. 2015 Apr 20
- The project data sphere initiative: accelerating cancer research by sharing data.[Oncologist. 2015]The project data sphere initiative: accelerating cancer research by sharing data.Green AK, Reeder-Hayes KE, Corty RW, Basch E, Milowsky MI, Dusetzina SB, Bennett AV, Wood WA. Oncologist. 2015 May; 20(5):464-e20. Epub 2015 Apr 15.
- Procedures and methods of benefit assessments for medicines in Germany.[Eur J Health Econ. 2008]Procedures and methods of benefit assessments for medicines in Germany.Bekkering GE, Kleijnen J. Eur J Health Econ. 2008 Nov; 9 Suppl 1:5-29.
- [Procedures and methods of benefit assessments for medicines in Germany].[Dtsch Med Wochenschr. 2008][Procedures and methods of benefit assessments for medicines in Germany].Bekkering GE, Kleijnen J. Dtsch Med Wochenschr. 2008 Dec; 133 Suppl 7:S225-46. Epub 2008 Nov 25.
- Review Sharing Clinical Research Data: Workshop Summary[ 2013]Review Sharing Clinical Research Data: Workshop SummaryInstitute of Medicine (US). 2013 Mar 29
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