An efficient sequential design of clinical trials

作者：Cheng Yi^*; Shen Yu

来源：Journal of Statistical Planning and Inference, 2013, 143(2): 283-295.

DOI：10.1016/j.jspi.2012.07.015

• Decision theory
• Group sequential clinical trial design
• Loss function
• Predicted power
• Reduced-bias estimator

We propose an efficient group sequential monitoring rule for clinical trials. At each interim analysis both efficacy and futility are evaluated through a specified loss structure together with the predicted power. The proposed design is robust to a wide range of priors, and achieves the specified power with a saving of sample size compared to existing adaptive designs. A method is also proposed to obtain a reduced-bias estimator of treatment difference for the proposed design. The new approaches hold great potential for efficiently selecting a more effective treatment in comparative trials. Operating characteristics are evaluated and compared with other group sequential designs in empirical studies. An example is provided to illustrate the application of the method.

• 出版日期2013-2