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

Real-World Evidence Generation and Evaluation of Therapeutics: Proceedings of a Workshop
ISBN-10
0309455650
ISBN-13
9780309455657
Category
Medical
Pages
102
Language
English
Published
2017-07-05
Publisher
National Academies Press
Authors
Board on Health Sciences Policy, Health and Medicine Division, Engineering

Description

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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