A stochastically curtailed single-arm phase II trial design for binary outcomes.

ABSTRACT: Phase II clinical trials are a critical aspect of the drug development process. With drug development costs ever increasing, novel designs that can improve the efficiency of phase II trials are extremely valuable.Phase II clinical trials for cancer treatments often measure a binary outcome. The final trial decision is generally to continue or cease development. When this decision is based solely on the result of a hypothesis test, the result may be known with certainty before the planned end of the trial. Unfortunately, there is often no opportunity for early stopping when this occurs.Some existing designs do permit early stopping in this case, accordingly reducing the required sample size and potentially speeding up drug development. However, more improvements can be achieved by stopping

SUBMITTER: Law M 

PROVIDER: S-EPMC7614398 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature