Real-World Evidence in Medical Product Development
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 standard for the evaluation of efficacy and safety of medical produ...
Tallennettuna:
| Yhteisötekijä: | |
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| Muut tekijät: | , , |
| Aineistotyyppi: | Elektroninen E-kirja |
| Kieli: | englanti |
| Julkaistu: |
Cham :
Springer International Publishing : Imprint: Springer,
2023.
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| Painos: | 1st ed. 2023. |
| Aiheet: | |
| Linkit: | https://doi.org/10.1007/978-3-031-26328-6 |
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Sisällysluettelo:
- 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.