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Suggested Citation:"Appendix A: Statement of Task." Institute of Medicine. 2014. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. Washington, DC: The National Academies Press. doi: 10.17226/18610.
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A


Statement of Task

An ad hoc committee of the Institute of Medicine will conduct a study to develop guiding principles and a framework (activities and strategies) for the responsible sharing of clinical trial data. For the purposes of the study, the scope will be limited to interventional clinical trials and “data sharing” will include the responsible entity (data generator) making the data available via open or restricted access, or exchanged among parties. For the purposes of this study, data generator will include industry sponsors, data repositories, and researchers conducting clinical trials. Specifically, the committee will

•   Articulate guiding principles that underpin the responsible sharing of clinical trial data.

•   Describe a selected set of data and data sharing activities, including, but not limited to

image   types of data (e.g., summary, participant);

image   provider(s) and recipient(s) of shared data; and

image   whether and when data are disclosed publicly, with or without restrictions, or exchanged privately among parties.

•   For each data sharing activity, the committee will

image   identify key benefits of sharing and risks of not sharing to research sponsors and investigators, study participants, regulatory agencies, patient groups, and the public.

image   address key challenges and risks of sharing (e.g., resource constraints, implementation, disincentives in the academic research model, changing norms, protection of human subjects and patient privacy, IP [intellectual property]/legal issues, preservation of scientific standards and data quality).

Suggested Citation:"Appendix A: Statement of Task." Institute of Medicine. 2014. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. Washington, DC: The National Academies Press. doi: 10.17226/18610.
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image   Outline strategies and suggest practical approaches to facilitate responsible data sharing.

•   Make recommendations to enhance responsible sharing of clinical trial data. The committee will identify guiding principles and characteristics for the optimal infrastructure and governance for sharing clinical trial data, taking into consideration a variety of approaches (e.g., a distributed/federated data system).

In developing the principles and framework and in defining the rights, responsibilities, and limitations underpinning the responsible sharing of clinical trial data, the committee will take into account the benefits of data sharing, the potential adverse consequences of both sharing and not sharing data, and the landscape of regulations and policies under which data-sharing occurs. Focused consideration will also be given to the ethical standards and to integrating core principles and values, including privacy. The committee is not expected to develop or define specific technical data standards.

A framework for discussion will be released for public comment, which will include tentative findings regarding (a) guiding principles and (b) a selected set of data sharing activities. Based on the public comments received and further deliberations, the committee will prepare a final report with its findings and recommendations.

Suggested Citation:"Appendix A: Statement of Task." Institute of Medicine. 2014. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. Washington, DC: The National Academies Press. doi: 10.17226/18610.
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Page 43
Suggested Citation:"Appendix A: Statement of Task." Institute of Medicine. 2014. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. Washington, DC: The National Academies Press. doi: 10.17226/18610.
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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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