Single-Arm Phase II Survival Trial Design

Jianrong (John) Wu is a professor in the Division of Cancer Biostatistics, Department of Internal Medicine, University of Kentucky; Biostatistics and Bioinformatics Shared Resource, Markey Cancer Center. Dr. Wu has more than 20 years’ experience of designing and conducting cancer clinical trials at St. Jude Children’s Research Hospital and Markey Cancer Center and has developed many novel statistical methods for designing and monitoring single-arm phase II and randomized phase III trial design with time-to-event endpoints.

1. Introduction of Single-Arm Phase II Trial Design
2. Phase II Trial Design Under Parametric Model
3. One-Stage Design Evaluating Survival Probabilities
4. Two-Stage Design Evaluating Survival Probabilities
5. One-Stage Design Evaluating Survival Distributions
6. Two-Stage Design Evaluating Survival Distributions
7. Phase II Immunotherapy Trial Design
8. Phase II Trial Design with GMI Endpoint
9. Bayesian Single-Arm Phase II Trial Design
Appendix A. Probability of Failure Under Uniform Accrual
Appendix B. Asymptotic Distribution of Nelson-Aalen Estimate of the Cumulative Hazard
Appendix C. Derivation Asymptotic Distribution of the OSLRT
Appendix D. Derivation of equations (6.8) and (6.9)
Appendix E. Crossing point for the mixture cure model
Appendix F. Derivation asymptotic distribution of the score test Q
Appendix G. Generate random variables from GBVE model
Appendix H. Derivation censoring survival distribution of GMI
Appendix I. Proof of monotonicity of the posterior probability
Appendix J. Relationship between frequentist and Bayesian type I error rates
Appendix K. R Code