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Discussion Framework for Clinical Trial Data Sharing
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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. Table of ContentsFront MatterDiscussion Framework for Clinical Trial Data SharingReferencesAppendix A: Statement of TaskAppendix B: Committee BiographiesAppendix C: Figure 1: Data Flow from Participant to Analyzed Dataand Reporting
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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. Table of ContentsFront MatterDiscussion Framework for Clinical Trial Data SharingReferencesAppendix A: Statement of TaskAppendix B: Committee BiographiesAppendix C: Figure 1: Data Flow from Participant to Analyzed Dataand Reporting
Produktdetaljer
Sprog: Engelsk
Sider: 72
ISBN-13: 9780309297790
Indbinding: Paperback
Udgave:
ISBN-10: 0309297796
Udg. Dato: 22 feb 2014
Længde: 0mm
Bredde: 229mm
Højde: 152mm
Oplagsdato: 22 feb 2014
Forfatter(e) Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine


Kategori Social- og sundhedsuddannelser


Sprog Engelsk


Indbinding Paperback


Sider 72


Udgave


Længde 0mm


Bredde 229mm


Højde 152mm


Udg. Dato 22 feb 2014


Oplagsdato 22 feb 2014

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