Statistical Design, Monitoring, and Analysis of Clinical Trials: Principles and Methods

ISBN-13: 9780367772444 / Angielski / Twarda / 2021 / 320 str.

Weichung Joe Shih; Joseph Aisner

Opis

This book concentrates on the biostatistics component of clinical trials. This new, second edition is updated throughout and includes three new chapters. This text reflects the academic research, commercial development, and public health aspects of clinical trials.

Recenzje

"This book gives a good overview a bout various aspects of statistics in the design, monitoring and analysis of clinical trials and covers also modern topics. In my opinion this book can not only be helpful for teaching, but could also be a very helpful guidebook for inexperienced statistic ians as well as other researchers who are just starting to work in the field of clinical trials. It may also be a good tool to help the communication between multidisciplinary trial teams, as it covers the topics from several angles and does not purely foc us on statistics."

- Stefanie Hayoz, ISCB News, September 2022.

Spis treści

1. Overview. 2. Concepts and Methods of Statistical Designs. 3. Efficiency with Trade-Offs and Crossover Designs. 4. Sample Size and Power Calculations. 5. Analysis of Covariance and Stratified Analysis. 6. Regression Analysis of Survival Data 7.  Sequential Designs and Methods—Part I: Expected Sample Size and Two-Stage Phase II Trials in Oncology 8. Sequential Designs and Methods—Part II: Monitoring Safety and Futility 9. Sequential Designs and Methods—Part III: Classical Group Sequential Trials 10. Monitoring the Maximum Information and Adaptive Sample-Size Designs 11. Multiplicity Issues and Methods for Controlling the Type-I Error Rate. 12.Clinical Trials with Predictive Biomarkers. 13. Seamless Phase II/III: Select-the-Winner Design. 14. Statistical Significance and p-Values. 15. Estimand, Intercurrent Events, and Missing Data.