- 學位論文
A Two-Stage Design for Stratified Phase II Clinical Trials with Continuous Endpoints
A Two-Stage Design for Stratified Phase II Clinical Trials with Continuous Endpoints
並列摘要
Pharmaceutical development is a high investment, and spends a lot of time on testing the efficacy of drugs. Clinical trials play an important role in pharmaceutical development. Therefore, how to effectively shorten the testing time and reduce the cost is what we need. A two-stage design can effectively shorten the testing time and reduce the cost in the pharmaceutical development for phase studies. However, in a two-stage design, the patient population for a phase clinical trial is sometimes heterogeneous. It is well known that stratification of clinical trials can be used to ensure equal assignment of subgroups of patients to each experimental condition. Hence, a phase clinical trial can be stratified according to age, gender, or other demographic factors. In this paper, we study a two-stage design for stratified phase clinical trials with continuous endpoints to evaluate the treatment effect across all strata, rather than within an individual stratum.