title: An Application of Graphical Approach to Construct Multiple Testing Procedures in a Hypothetical Phase III Design.
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.
authors.affiliation: Biometrics, Boehringer-Ingelheim Pharmaceuticals, Inc. , Ridgefield, CT , USA.
authors.forename: Bushi
authors.initials: B
authors.lastname: Wang
authors.affiliation: Biometrics, Boehringer-Ingelheim Pharmaceuticals, Inc. , Ridgefield, CT , USA.
authors.forename: Naitee
authors.initials: N
authors.lastname: Ting
keywords: dose selection; multiple endpoints; multiple testing procedures; non-inferiority; superiority and non-inferiority