Real-world evidence generation and evaluation of therapeutics proceedings of a workshop

The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to de...

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Bibliographic Details
Main Author: Downey, Autumn S.
Corporate Authors: National Academies of Sciences, Engineering, and Medicine (U.S.) Forum on Drug Discovery, Development, and Translation, Real-World Evidence Generation and Evaluation of Therapeutics (Workshop) (2016, Washington, D.C.)
Other Authors: Gee, Amanda Wagner ([rapporteur]), Claiborne, Anne B. ([rapporteur])
Format: eBook
Language:English
Published: Washington, DC the National Academies Press 2017, [2017]
Subjects:
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Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Description
Summary:The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop
Physical Description:1 PDF file (xvi, 85 pages) illustrations
ISBN:9780309455626
0309455626