000			01713nam a22003015i 4500
001			91421
005			20240206134537.0
010			_a978-3-031-26328-6 _dcompra
090			_a91421
100			_a20231023d2023 k||y0pory50 ba
101	0		_aeng
102			_aCH _bCham
200	1		_aReal-world evidence in medical product development _bDocumento eletrónico _gedited by Weili He, Yixin Fang, Hongwei Wang
210			_aCham _cSpringer International Publishing _dcop. 2023
215			_aXXVII, 417 p. _cil.
303			_aThis book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.
606			_aStatistics
606			_aArtificial intelligence _xData processing
606			_aComputer science _xMathematics
680			_aQA276-280
702			_946460 _aHe _bWeili _4340
702			_970609 _aFang _bYixin _4340
702			_970611 _aWang _bHongwei _4340
801		0	_aPT _gRPC
856	4		_uhttps://doi.org/10.1007/978-3-031-26328-6
942			_2lcc _cF _n0