Single-Arm Phase II Survival Trial Design

Jianrong Wu

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English

Chapman & Hall/CRC
20 July 2021

Clinical trials; Epidemiology & medical statistics

Series: Chapman & Hall/CRC Biostatistics Series

Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software.

Key Features:

Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion.

Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint.

Illustrates trial designs by real clinical trial examples

Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.

By: Jianrong Wu
Imprint: Chapman & Hall/CRC
Country of Publication: United Kingdom
Dimensions: Height: 234mm, Width: 156mm,
Weight: 521g
ISBN: 9780367653453
ISBN 10: 0367653451
Series: Chapman & Hall/CRC Biostatistics Series
Pages: 263
Publication Date: 20 July 2021
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Active

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

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.

Reviews for Single-Arm Phase II Survival Trial Design

I would say it is a great book, great summary of not so common and widely available methods, focusing for a statistical audience with strong statistical skills. David Manteigas, Portugal, ISCB News, June 2022.