2nd Edition
Group Sequential and Adaptive Methods for Clinical Trials
1. Introduction
2. Two-Sided Tests: Introduction
3. A Unified Formulation and the General Calculation
4. Two-sided Tests: General Applications
5. One-Sided Tests
6. Two-Sided Tests with Early Stopping Under the Null Hypothesis
7. Tests for Equivalence and Non-inferiority
8. Information Monitoring: The Error Spending Approach
9. Analysis Following a Sequential Test
10. Repeated Coincidence Intervals
11. Stochastic Curtailment
12. Optimal Group Sequential Tests
13. Bayesian Approaches
14. Group Sequential Tests for Delayed Observations
15. General Group Sequential Distribution Theory
16. Binary Data
17. Survival Data
18. Nuisance Parameters: Internal Pilot Studies, Sample Size Re-estimation and Information Monitoring
19. Multivariate Endpoints
20. Multiple Hypotheses: Primary and Secondary Endpoints
21. Multi-Arm Multi-Stage Trials
22. From Group Sequential to Adaptive Designs: Flexible Sample Size Re-Assessment
23. Adaptive Combination Tests
24. Sample Size Re-assessment given an Interim Estimate of Treatment Effect
25. Adaptive Trials Testing Multiple Hypotheses: Closed Testing Procedures with Combination Tests
26. Treatment Selection and Testing: Seamless Phase II/III Trials
27. Adaptive Multi-Arm Multi-Stage Phase III Trials
28. Enrichment Designs: Targeting Therapies to Selected Sub-Populations
29. Adaptive Seamless Design: A Case Study with Intermediate and Long- Term Survival Endpoints
30. Response Adaptive Treatment Assignment
31. Numerical Computations for Group Sequential and Adaptive Tests
Biography
Christopher Jennison is Professor of Statistics in the Department of Mathematical Sciences, University of Bath, UK. He has worked on the analysis of clinical trials at the Dana-Farber Cancer Institute, Boston and collaborated with medical researchers in areas such as cancer research, cardiology, gynaecology, and complementary medicine.
Bruce Turnbull is Emeritus Professor of Statistics in the School of Operations Research & Industrial Engineering and in the Department of Statistical Science, Cornell University, USA. He has a long experience of designing, monitoring, and analyzing clinical trials and has served on the Data Safety Monitoring Boards for international, multi-center trials for the treatment or prevention of cancer, heart disease and AIDS. He has also served as a consultant to pharmaceutical companies and health-related government review panels.
