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.

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