|서명/저자사항||Examining the impact of real-world evidence on medical product development [electronic resource]: proceedings of a workshop series/ Erin Hammers Forstag, Benjamin Kahn, Amanda Wagner Gee, and Carolyn Shore, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine.|
|개인저자||Forstag, Erin Hammers,rapporteur.|
Gee, Amanda Wagner,rapporteur.
|단체저자명||National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Drug Discovery, Development, and Translation,issuing body.|
|발행사항||Washington, DC: the National Academies Press, 2019.|
|형태사항||1 online resource (ix, 207 pages): color illustrations.|
|기타형태 저록||Print version: Examining the impact of real-world evidence on medical product development. Washington, DC: National Academies Press, 2019, 030948829X |
|서지주기||Includes bibliographical references (pages 177-180).|
|내용주기||Introduction -- Perspectives on real-world evidence -- Learning from success -- Barriers and disincentives to the use of real-world evidence and real-world data -- Getting unstuck : mythbusting the current system -- When is a real-world data element fit for assessment of eligibility, treatment exposure, or outcomes? -- How tightly should investigators attempt to control or restrict treatment quality in a pragmatic or real-world trial? -- Obscuring intervention allocation in trials to generate real-world evidence : why, who, and how? -- Gaining confidence in observational comparisons -- Looking ahead -- References -- Appendixes|
|요약||"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"--Publisher's description|
|회의명||Examining the Impact of Real-World Evidence on Medical Product Development (Workshop) (2018 : Washington, D.C.), |
|일반주제명||Evidence-based medicine --Decision making --Congresses.|
Drugs --Testing --Congresses.
Medical instruments and apparatus --Congresses.