MARC Record from marc_columbia

LEADER: 03834cam a2200421Ki 4500
001 13894661
005 20190620163608.0
008 190318t20192019dcua b 000 0 eng d
035 $a(OCoLC)on1089854782
040 $aYDX$beng$erda$cYDX$dEEM$dOCLCF$dOCLCO
020 $a030948829X
020 $a9780309488297
035 $a(OCoLC)1089854782
050 4 $aR723.7$b.F67 2019
049 $aZCUA
100 1 $aForstag, Erin Hammers,$erapporteur.
245 10 $aExamining the impact of real-world evidence on medical product development :$bproceedings 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.
264 1 $aWashington, DC :$bthe National Academies Press,$c[2019].
264 4 $c©2019
300 $axxi, 207 pages :$billustrations ;$c23 cm.
336 $atext$btxt$2rdacontent
337 $aunmediated$bn$2rdamedia
338 $avolume$bnc$2rdacarrier
504 $aIncludes bibliographical references (pages 177-180).
505 0 $aIntroduction -- 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
520 $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"--Publisher's description
650 0 $aDrugs$xTesting$vCongresses.
650 0 $aEvidence-based medicine$xDecision making$vCongresses.
650 0 $aMedical instruments and apparatus$vCongresses.
650 7 $aDrugs$xTesting.$2fast$0(OCoLC)fst00898940
650 7 $aMedical instruments and apparatus.$2fast$0(OCoLC)fst01014194
655 7 $aConference papers and proceedings.$2fast$0(OCoLC)fst01423772
700 1 $aKahn, Benjamin,$erapporteur.
700 1 $aGee, Amanda Wagner,$erapporteur.
700 1 $aShore, Carolyn,$erapporteur.
710 2 $aNational Academies of Sciences, Engineering, and Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation,$eissuing body.
711 2 $aExamining the Impact of Real-World Evidence on Medical Product Development (Workshop)$d(2018 :$cWashington, D.C.),$jissuing body.
852 00 $boff,sci$hR723.7$i.F67 2019g