Sample Size in Adaptive Design with Treatment Selection

• Activity Number: 359 - Contributed Poster Presentations: Biopharmacutical Section
• Type: Contributed
• Date/Time: Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Zejiang Yang*
• Companies: Syneos Health
• Keywords: treatment selection; sample size; simulation; Bonferroni; Holm

Abstract

Treatment selection method is an important application of adaptive design in clinical studies. This paper will extend the simulation-based approach and Bonferroni-Holm test procedure in Posch et al. (2011) to a normally distributed endpoint assuming varying selection rules. We assume that the study has two active treatments and a control group with one interim analysis, and use the following treatment selection rules based on interim analysis results: (1) select one active treatment with a better response than other active treatment by a pre-specified threshold; (2) early termination is allowed if it meets the pre-specified criteria. How to determine critical boundaries to maintain Type I error under these scenarios, and how to calculate the sample size to achieve the target statistical power will be presented.