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portada Real-World Evidence Generation and Evaluation of Therapeutics. Proceedings of a Workshop
Type
Physical Book
Publisher
Author
Year
2017
Pages
102
Format
Paperback
Dimensions
22.9x15.2x2.5 cm
ISBN13
9780309455626

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

Board On Health Sciences Policy;Autumn Downey;Anne B. Claiborne;Amanda Wagner Gee;Health And Medicine Division;Engineering, And Medicine National Academies Of Sciences;Development, And Translation Forum On Drug Discovery (Author) · National Academies Press · Paperback

Real-World Evidence Generation and Evaluation of Therapeutics. Proceedings of a Workshop - Board on Health Sciences Policy;Autumn Downey;Anne B. Claiborne;Amanda Wagner Gee;Health and Medicine Division;Engineering, and Medicine National Academies of Sciences;Development, and Translation Forum on Drug Discovery

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Synopsis "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 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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