Optimal two-stage design of single arm Phase II clinical trials based on median event time test.

ABSTRACT: The Phase II clinical trials aim to assess the therapeutic efficacy of a new drug. The therapeutic efficacy has been often quantified by response rate such as overall response rate or survival probability in the Phase II setting. However, there is a strong desire to use survival time, which is the gold standard endpoint for the confirmatory Phase III study, when investigators set the primary objective of the Phase II study and test hypotheses based on the median survivals. We propose a method for median event time test to provide the sample size calculation and decision rule of testing. The decision rule is simple and straightforward in that it compares the observed median event time to the identified threshold. Moreover, it is extended to optimal two-stage design for practice, which exten

SUBMITTER: Park Y 

PROVIDER: S-EPMC7870013 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature