Real-World Evidence in Medical Product Development

Edited by Weili He (), Yixin Fang () and Hongwei Wang ()

in Springer Books from Springer

Date: 2023
ISBN: 978-3-031-26328-6
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Chapters in this book:

The Need for Real-World Evidence in Medical Product Development and Future Directions

Weili He, Yixin Fang, Hongwei Wang and Charles Lee

Overview of the Current Real-World Evidence Regulatory Landscape

Rima Izem, Ruthanna Davi, Jingyu Julia Luan and Margaret Gamalo

Key Considerations in Forming Research Questions and Conducting Research in Real-World Setting

Yixin Fang and Weili He

Assessment of Fit-for-Use Real-World Data Sources and Applications

Weili He, Zuoyi Zhang and Sai Dharmarajan

Key Variables Ascertainment and Validation in RW Setting

Sai Dharmarajan and Tae Hyun Jung

Data Standards and Platform Interoperability

Nigel Hughes and Dipak Kalra

Privacy-Preserving Record Linkage for Real-World Data

Tianyu Zhan, Yixin Fang and Weili He

Causal Inference with Targeted Learning for Producing and Evaluating Real-World Evidence

Susan Gruber, Hana Lee, Rachael Phillips and Mark van der Laan

Estimand in Real-World Evidence Study: From Frameworks to Application

Ying Wu, Hongwei Wang, Jie Chen and Hana Lee

Clinical Studies Leveraging Real-World Data Using Propensity Score-based Methods

Heng Li and Lilly Q. Yue

Recent Statistical Development for Comparative Effectiveness Research Beyond Propensity-Score Methods

Yixin Fang

Innovative Hybrid Designs and Analytical Approaches Leveraging Real-World Data and Clinical Trial Data

Lisa V. Hampson and Rima Izem

Statistical Challenges for Causal Inference Using Time-to-Event Real-World Data

Jixian Wang, Hongtao Zhang and Ram Tiwari

Sensitivity Analyses for Unmeasured Confounding: This Is the Way

Douglas Faries

Sensitivity Analysis in the Analysis of Real-World Data

Yixin Fang and Weili He

Personalized Medicine with Advanced Analytics

Hongwei Wang, Dai Feng and Yingyi Liu

Use of Real-World Evidence in Health Technology Assessment Submissions

Yingyi Liu and Julia Ma

Examples of Applying Causal-Inference Roadmap to Real-World Studies

Yixin Fang

Applications Using Real-World Evidence to Accelerate Medical Product Development

Weili He, Tae Hyun Jung, Hongwei Wang and Sai Dharmarajan

The Use of Real-World Data to Support the Assessment of the Benefit and Risk of a Medicine to Treat Spinal Muscular Atrophy

Tammy McIver, Muna El-Khairi, Wai Yin Yeung and Herbert Pang

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DOI: 10.1007/978-3-031-26328-6

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