Weighted rank tests for noninferiority hypotheses based on paired survival times.

Motivated by the design and analysis of a specific type of Phase II cancer clinical trials, we derive in this article a class of weighted rank tests for the testing of noninferiority hypotheses with a prespecified margin based on paired survival times. Monte Carlo simulations are performed to evaluate the performance of the proposed tests. Sample size calculation when these tests are used for the analysis is also discussed. Procedures developed are also applied to a Phase II clinical trial of metastatic breast cancer.