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Statistical Design, Monitoring, and Analysis of Clinical Trials
ISBN-13:
9781000462814
Veröffentl:
2021
Seiten:
404
Autor:
Weichung Joe Shih
eBook Typ:
EPUB
eBook Format:
EPUB
Kopierschutz:
0 - No protection
Sprache:
Englisch
Beschreibung:
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.
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.
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