Abstract
Many multiple testing procedures (MTP) have been developed in recent years. Among these new procedures, the graphical approach is flexible and easy to communicate with non-statisticians. A hypothetical Phase III clinical trial design is introduced in this manuscript to demonstrate how graphical approach can be applied in clinical product development. In this design, an active comparator is used. It is thought that this test drug under development could potentially be superior to this comparator. For comparison of efficacy, the primary endpoint is well established and widely accepted by regulatory agencies. However, an important secondary endpoint based on Phase II findings looks very promising. The target dose may have a good opportunity to deliver superiority to the comparator. Furthermore, a lower dose is included in case the target dose may demonstrate potential safety concerns. This Phase III study is designed as a non-inferiority trial with two doses, and two endpoints. This manuscript will illustrate how graphical approach is applied to this design in handling multiple testing issues.
Highlights
There has been a rapid development in multiple testing procedures (MTP) in the past 10 years
Numerous of new procedures have been proposed to deal with multiple testing problems with single source of multiplicity, and more complex multiple testing problems involving more than one source of multiplicity
To meet the demand of more complex trial design and strong control of family-wise error rate, several papers have been published in recent years to construct powerful yet flexible MTP
Summary
A hypothetical Phase III clinical trial design is introduced in this manuscript to demonstrate how graphical approach can be applied in clinical product development. In this design, an active comparator is used. A lower dose is included in case the target dose may demonstrate potential safety concerns This Phase III study is designed as a non-inferiority trial with two doses, and two endpoints. This manuscript will illustrate how graphical approach is applied to this design in handling multiple testing issues
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