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现实世界的证据,以告知监管决策:一个范围审查

Marieke S Jansen1, Olaf M Dekkers1,2,3, Saskia le Cessie1,4

  • 1Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Clinical pharmacology and therapeutics
|February 23, 2024
PubMed
概括

现实世界的证据 (RWE) 对监管决策至关重要,其必要性受到流行病学,利益风险评估,可行性和道德考虑等因素的影响. 这些因素的累积影响决定了RWE在决策过程中的重要作用.

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