Power and Sample Size Calculation Using Graphical Approaches

• Activity Number: 60
• Type: Topic Contributed
• Date/Time: Sunday, August 9, 2015 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Dong Xi* and Willi Maurer and Ekkehard Glimm and Frank Bretz
• Companies: Novartis and Novartis and Novartis and Novartis
• Keywords: Clinical trials ; multiplicity ; power ; sample size ; graphical approaches

Abstract

Power and sample size calculation is an essential part of clinical trial design. However, it could become complicated in trials with multiple objectives and there is a need for a flexible and intuitive way to carry out the calculation. Graphical approaches can be applied to common multiple test problems, such as comparing several treatments with a control, assessing the benefit of a new drug for more than one endpoint, and combined non-inferiority and superiority testing. Using graphical approaches, one can easily construct and explore different testing strategies and thus tailor the test procedure to the given study objectives. In this presentation, we illustrate power and sample size calculation to optimize a multiple test procedure for given study objectives. The calculation will be demonstrated using a clinical trial example. The presented methods will be illustrated using the graphical user interface from the gMCP package in R, which is freely available on CRAN.