Curtailed Two-Stage Design for Comparing Two Binomial Proportions in Phase II Clinical Trials

• Activity Number: 350
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Chia-Min Chen*+
• Companies: Nanhua University
• Keywords: curtailed two-stage design ; expected sample size ; design parameters

Abstract

In a drug development process, patients enter a phase II clinical trial sequentially and hence their responses to the treatment are reported consecutively. When the accrual rate is low, the drug development process becomes very long and may delay the release of a promising new drug to the public. For a single-arm trial, Chi and Chen (2008) provided a curtailed two-stage designs to speed up the drug development process. However, to the best of our knowledge, there is not any literature investigating the curtailed design for comparing two binomial proportions. Therefore, following the idea of Chi and Chen (2008), this paper proposes curtailed two-stage designs for comparing two binomial proportions to shorten the drug development process as soon as the new drug either shows lack of efficacy or is very effective. Moreover, for the pre-specified significant level and power, the suitable design parameters will be derived based on Simon's minimax and optimal criteria.