Intermediate Monitoring, Sample Size Reassessment, and Multi-Treatment Optimal Response-Adaptive Designs for Phase III Clinical Trials with More Than One Constraint

Abstract

Optimal response-adaptive designs in Phase III clinical trial set up are becoming more and more current interest. In the present article, an optimal response-adaptive design is introduced for more than two treatments at hand. We minimize an objective function subject to more than one inequality constraints. For this purpose, we propose an extensive computer search algorithm. The proposed procedure is illustrated with extensive numerical computation and simulations. Some real data set is used to illustrate the proposed methodology.

Keywords:

• Constraints
• Ethical allocation
• Group sequential design
• Minimization

Mathematics Subject Classification:

• 62L05
• 62K05

Acknowledgment

The authors wish to thank the referee for his careful reading and constructive suggestions which led to some improvement over an earlier version of the manuscript.