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180702 r ||| eng |
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|a 9780309455626
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|a 0309455626
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|a Downey, Autumn S.
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|a Real-world evidence generation and evaluation of therapeutics
|h Elektronische Ressource
|b proceedings of a workshop
|c Autumn Downey, Amanda Wagner Gee, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine
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|a Washington, DC
|b the National Academies Press
|c 2017, [2017]
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|a 1 PDF file (xvi, 85 pages)
|b illustrations
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|a Includes bibliographical references
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|a Therapeutics / methods
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|a Data Mining / methods
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|a Drug Therapy / methods
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|a Electronic Health Records
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|a Evidence-Based Medicine / methods
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|a Gee, Amanda Wagner
|e [rapporteur]
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|a Claiborne, Anne B.
|e [rapporteur]
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|a National Academies of Sciences, Engineering, and Medicine (U.S.)
|b Forum on Drug Discovery, Development, and Translation
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|a Real-World Evidence Generation and Evaluation of Therapeutics (Workshop) (2016, Washington, D.C.)
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|a eng
|2 ISO 639-2
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|b NCBI
|a National Center for Biotechnology Information
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|u https://www.ncbi.nlm.nih.gov/books/NBK424402
|3 Volltext
|n NLM Bookshelf Books
|3 Volltext
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|a 610
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|a 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
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