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|a 9780309488297
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|a 030948829X
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|a Forstag, Erin Hammers
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|a Examining the impact of real-world evidence on medical product development
|h Elektronische Ressource
|b proceedings of a workshop series
|c Erin Hammers Forstag, Benjamin Kahn, Amanda Wagner Gee, and Carolyn Shore, rapporteurs ; Forum on Drug Discovery, Board on Health Sciences Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine
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|a Washington, DC
|b National Academies Press
|c [2019], 2019
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|a 1 PDF file (xxi, 207 pages)
|b illustrations
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|a Includes bibliographical references
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|a Congresses as Topic
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|a Equipment and Supplies
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|a Biomedical Research
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|a Evidence-Based Practice
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|a Kahn, Benjamin
|e [rapporteur]
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|a Gee, Amanda Wagner
|e [rapporteur]
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|a Shore, Carolyn
|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 Examining the Impact of Real-World Evidence on Medical Product Development (Workshop)
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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/NBK539609
|3 Volltext
|n NLM Bookshelf Books
|3 Volltext
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|a 610
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|a Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series
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