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Examining the Impact of Real-World Evidence on Medical Product Development
Language: en
Pages: 231
Authors: National Academies of Sciences, Engineering, and Medicine
Categories: Medical
Type: BOOK - Published: 2019-05-05 - Publisher: National Academies Press

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Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inher
Real-World Evidence Generation and Evaluation of Therapeutics
Language: en
Pages: 103
Authors: National Academies of Sciences, Engineering, and Medicine
Categories: Medical
Type: BOOK - Published: 2017-07-05 - Publisher: National Academies Press

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The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects
Real-World Evidence in Drug Development and Evaluation
Language: en
Pages: 191
Authors: Harry Yang
Categories: Mathematics
Type: BOOK - Published: 2021-01-11 - Publisher: CRC Press

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Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process ai
Registries for Evaluating Patient Outcomes
Language: en
Pages: 396
Authors: Agency for Healthcare Research and Quality/AHRQ
Categories: Medical
Type: BOOK - Published: 2014-04-01 - Publisher: Government Printing Office

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase unders
Real-World Evidence in Medical Product Development
Language: en
Pages: 431
Authors: Weili He
Categories: Mathematics
Type: BOOK - Published: 2023-05-11 - Publisher: Springer Nature

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This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioner