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Sample Size Determination for Power Analysis with Hierarchical Endpoints in Group Sequential Designs

Abstract Number:

3882 

Submission Type:

Contributed Abstract 

Contributed Abstract Type:

Poster 

Participants:

Xiaohang Mei (1), Kimberly Carlson (2), Dulal Bhaumik (3)

Institutions:

(1) N/A, N/A, (2) Cooperative Studies Program Coordinating Center, N/A, (3) University of Illinois At Chicago, N/A

Co-Author(s):

Kimberly Carlson  
Cooperative Studies Program Coordinating Center
Dulal Bhaumik  
University of Illinois At Chicago

First Author:

Xiaohan Mei  
N/A

Presenting Author:

Xiaohan Mei  
N/A

Abstract Text:

The increasing demand for drug efficacy research underscores the importance of addressing the hypothesis testing problem in both primary and secondary endpoints during the designing phase of clinical trials. This necessitates for an adjustment of multiplicity, particularly in hierarchical endpoints, a concept known as multiple endpoint testing. However, in group sequential designs, the statistical procedure for adjustment of the overall type I error rate of multiple hypotheses becomes complex. While the existing literature on gatekeeping procedures and alpha splitting effectively controls the family-wise error rate (FWER) and ensures sufficient power for testing primary endpoints, it falls short of providing adequate power for testing the secondary endpoint. This article introduces a model-based method for comparing a treatment's primary and secondary endpoints with those of a control. Additionally, a flexible approach for selecting the critical boundary of the secondary endpoint is developed to enhance the power of the corresponding hypothesis. Simulation results demonstrate that the proposed model-based method provides better adequate power with smaller samples while strictly con

Keywords:

Hierarchical Endpoints|Group Sequential Design|FWER Control|Power Analysis| |

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