Estimation of the binomial probabilities in a two-stage phase II clinical trial with two co-primary endpoints

摘要: In cancer research, two-stage designs are usually used to assess the effect of a new agent in phase II clinical trials. Optimal with two co-primary endpoints have been proposed effects treatments, such as cytostatic or molecularly targeted agents (MTAs), based on both response rate and early progression rate. Accurate estimation rates data from trials conducted according optimal would be very useful for further testing this paper, we derive some procedures, which include standard bias-corrected maximum likelihood estimates (MLE) uniformly minimum variance unbiased estimate (UMVUE), binomial probabilities define hypotheses tested trial. Simulation studies were performed evaluate performance these procedures. These procedures also applied analyze trial by Canadian Cancer Trials Group.