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Real-World Evidence Generation and Evaluation of Therapeutics : Proceedings of a Workshop

By: (Author) Board on Health Sciences Policy , (Author) and Translation Forum on Drug Discovery Development , (Author) and Medicine National Academies of Sciences Engineering , (Author) Health and Medicine Division , (Edited by) Amanda Wagner Gee , (Edited by) Anne B. Claiborne , (Edited by) Autumn Downey

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Ksh 9,900.00

Format: Paperback or Softback

ISBN-10: 0309455626

ISBN-13: 9780309455626

Publisher: National Academies Press

Imprint: National Academies Press

Country of Manufacture: GB

Country of Publication: GB

Publication Date: Aug 5th, 2017

Print length: 102 Pages

Product Classification: Medicine

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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. Table of ContentsFront Matter1 Introduction2 Improving Evidence Generation for Decision Making on Approval and Use of New Treatments: Some Stakeholder Priorities3 Opportunities for Real-World Data4 Generating and Incorporating Real-World Evidence into Medical Product Development and Evaluation: Building from Successful Case Studies5 Potential Strategies for a Way ForwardAppendix A: BibliographyAppendix B: Workshop AgendaAppendix C: Participant BiographiesAppendix D: Discussion Paper: Real-World Evidence to Guide theApproval and Use of New Treatments

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