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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Personalized Medicine with Advanced Analyticsally true as continued innovation in science and technology are delivering multiple interventions with different mechanism of actions for related comorbidity conditions. Real-world data (RWD) which typically includes a large, diverse, and heterogeneous patient population presents unique opportunity

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The Need for Real-World Evidence in Medical Product Development and Future Directions drug development, given the increasing uptake of RWE across regulatory, industry, and academia globally. Great progresses have been made in the last few years in this field, which we will review and summarize. Further, we will provide our thoughts on the further opportunities to address continued challenges and future directions.

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ters on estimand, causal inference roadmap, fit-for-purpose .This 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 standa

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Estimand in Real-World Evidence Study: From Frameworks to Application serve as guiding principles for defining real-world estimands. This chapter also provides examples of constructing an appropriate estimand in RWE studies, with detailed description on each of the five estimand attributes outlined in ICH E9(R1).

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Book 2023ractitioners 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 dev

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Key Considerations in Forming Research Questions and Conducting Research in Real-World Setting generate real-world data for research purpose. In category two, based on one or several existing real-world data sources, we design a retrospective real-world study. In category three, we utilize real-world data in the design, conduct, and analysis of clinical trials.

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