Summary: | 碩士 === 國立成功大學 === 統計學系碩博士班 === 96 === In a drug development process, the primary goal of phase II clinical trials is to determine whether there is sufficient evidence of efficacy and safety to make it worth further study in a phase III clinical trial. Most often, drug experiments employ a two-stage design, such as Conway and Petroni’s design (1995), in order to avoid giving patients an ineffective drug. Due to the nature of two-stage designs, the estimates of response rates should not be computed as if the data were obtained in a single stage. Therefore, this thesis derived bias-reduced estimators for two-stage designs based on bivariate endpoints when the second stage is allowed to continue. In addition, Sterne’s procedure is employed to obtain confidence region for bivariate response rates based on truncated bivariate binomial distribution.
|