Titlebook: Real-World Evidence in Medical Product Development; Weili He,Yixin Fang,Hongwei Wang Book 2023 The Editor(s) (if applicable) and The Autho

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書目名稱Real-World Evidence in Medical Product Development被引頻次學(xué)科排名




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書目名稱Real-World Evidence in Medical Product Development讀者反饋學(xué)科排名

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https://doi.org/10.1007/978-3-031-26328-6real-world evidence; real-world data; design bias; confounding control; regulatory science; machine learn

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978-3-031-26330-9The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl

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Overview of the Current Real-World Evidence Regulatory Landscaperld. We will first outline the key concepts underpinning evaluation of real-world evidence and discuss similarity and differences in those concepts in guidance documents from different countries. Then, we illustrate the regulatory practice of using real-world data throughout the product development

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Key Considerations in Forming Research Questions and Conducting Research in Real-World Settingred through real-world studies and the analysis of real-world data. The derived real-world evidence may be used to help support approval of a new indication for a medical product that has already been approved or to help support postapproval study requirements. We also discuss how to revise the rese

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Key Variables Ascertainment and Validation in RW Settingam. ., 2018). Key variables are those that define a key patient characteristic necessary to identify the study population of interest, the treatment/exposure, the outcome, or a key confounder whose effect must be adjusted for. With Real-World Data (RWD), often (1) exposure, outcomes, and key confoun