Estimands, Estimators and Sensitivity Analysis in Clinical Trials
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"The purpose of this book, which is to promote an integrated understanding of key concepts throughout the drug development process through an example-based approach, is certainly achieved. It is the holistic approach to planning the analysis and the focus on practical implementation that distinguishes this text from others... Overall, I enjoyed reading this book, which is a holistic and complete work and will be useful for researchers in the medical statistics area."
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- Taras Lukashiv, ISCB News, July 2020
The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language, providing technical details, real-world examples, and SAS and R code to implement analyses. Les mer
This book lays out a path toward bridging some of these gaps. It offers
A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges
A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1)
Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs:
A perspective on the role of the intention-to-treat principle
Examples and case studies from various areas
Example code in SAS and R
A connection with causal inference
Implications and methods for analysis of longitudinal trials with missing data
Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.
Detaljer
- Forlag
- CRC Press
- Innbinding
- Innbundet
- Språk
- Engelsk
- Sider
- 318
- ISBN
- 9781138592506
- Utgivelsesår
- 2020
- Format
- 23 x 16 cm
Anmeldelser
«
"The purpose of this book, which is to promote an integrated understanding of key concepts throughout the drug development process through an example-based approach, is certainly achieved. It is the holistic approach to planning the analysis and the focus on practical implementation that distinguishes this text from others... Overall, I enjoyed reading this book, which is a holistic and complete work and will be useful for researchers in the medical statistics area."
»
- Taras Lukashiv, ISCB News, July 2020