Real-world evidence in medical produ...
He, Weili.

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  • Real-world evidence in medical product development
  • 紀錄類型: 書目-電子資源 : Monograph/item
    正題名/作者: Real-world evidence in medical product development/ edited by Weili He, Yixin Fang, Hongwei Wang.
    其他作者: He, Weili.
    出版者: Cham :Springer International Publishing : : 2023.,
    面頁冊數: 1 online resource (xxvii, 417 p.) :ill., digital ;24 cm.
    內容註: Preface -- Part I. Real-World Data and Evidence to Accelerate Medical Product Development -- The need for real world data/evidence in clinical development and life cycle management, and future directions -- Overview of current RWE/RWD landscape -- Key considerations in forming research questions -- Part II. Fit-for-use RWD Assessment and Data Standards -- Assessment of fit-for-use real-world data sources and applications -- Key variables ascertainment and validation in real-world setting -- Data standards and platform interoperability -- Privacy-preserving data linkage for real-world datasets -- Part III. Causal Inference Framework and Methodologies in RWE Research -- Causal Inference with Targeted Learning for Producing and Evaluating Real-World Evidence -- Framework and Examples of Estimands in Real-World Studies -- Clinical Studies Leveraging Real-World Data Using Propensity Score-Based Methods -- Recent statistical development for comparative effectiveness research beyond propensity-score methods -- Innovative Hybrid Designs and Analytical Approaches leveraging Real-Word Data and Clinical Trial data -- Statistical challenges for causal inference using time-to-event real-world data -- Sensitivity Analyses for Unmeasured Confounding: This is the way -- Sensitivity analysis in the analysis of real-world data -- Personalized medicine with advanced analytics -- Use of Real-World Evidence in Health Technology Assessment Submissions -- Part IV. Application and Case studies -- Examples of applying causal-inference roadmap to real-world studies -- Applications using real-world evidence to accelerate medical product development -- The use of real-world data to support the assessment of the benefit and risk of a medicine to treat spinal muscular atrophy -- Index.
    Contained By: Springer Nature eBook
    標題: Drug development. -
    電子資源: https://doi.org/10.1007/978-3-031-26328-6
    ISBN: 9783031263286
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