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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Key Variables Ascertainment and Validation in RW Setting field, requiring natural language processing techniques such as information extraction be applied; (4) misclassification is a concern, requiring validation studies. This chapter will cover the above topics and walk through an example study for which the ascertainment of key variables was found to b

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Causal Inference with Targeted Learning for Producing and Evaluating Real-World Evidence data acquisition, estimation and inference using targeted minimum loss-based likelihood estimation and super learning; and (5) sensitivity analysis to quantify the robustness of study findings and level of support in the data for the substantive conclusion, including violations of the identificatio

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Sensitivity Analyses for Unmeasured Confounding: This Is the Wayps in any quantitative assessment of robustness to unmeasured confounding. We also argue that given these broadly applicable methods and published R-packages to remove implementation complexity, consistent application of quantitative sensitivity analyses is now practical.

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Personalized Medicine with Advanced Analyticsnfounding and quantify potential complex relationship between intervention and outcome. Therefore, advanced analytics are usually more suitable when addressing personalized medicine research questions. A few active areas include predictive modeling, natural language processing for free text to augme

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s 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..978-3-031-26330-9978-3-031-26328-6

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