Sample Size Estimation and Consideration for Japanese Subjects in a Multi-Regional Trial

• Activity Number: 458
• Type: Contributed
• Date/Time: Wednesday, August 6, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Jang Yun*+
• Keywords: regulatory guideline ; multi-regional clinical trials ; sample size consideration ; Japanese subjects

Abstract

To promote Japanese' participation in multi-regional clinical trials, the Ministry of Health and Welfare, the Japanese regulatory authority, issued a guideline to outline the basic principles for design and conduct of global clinical trials including Japanese subjects. Part of the guideline includes consideration for estimating the number of Japanese subjects in a multi-regional trial. Since no method had been established to calculate the sample size for Japanese subjects when designing a multi-regional trial, this guidance includes methods to ensure the assessment of consistent results between the entire study population and the Japanese study population. Quan, et al, (2010) expands on the guidance and comprehensively illustrates sample size estimation methods for Japanese subjects in multi-regional trials. Based on the review of the guidance and papers, this presentation will address statistical methods on sample size considerations for Japanese subjects in multi-regional trials. The presentation will include a demonstration of sample size calculations for different types of endpoints. Finally, the presentation will show the application of the approaches to the trial examples.