Abstract #302334

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JSM 2003 Abstract #302334
Activity Number: 219
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 9:00 AM to 10:50 AM
Sponsor: Biopharmaceutical Section
Abstract - #302334
Title: Sample Size Issues in Clinical Trial with Noninferiority Design
Author(s): Shen Jang Fann*+ and Chee Jen Chang and Shu Chen Chang
Companies: IBMS Academia Sinica and National Taiwan University Hospital and National Yang Ming
Address: 128 Academia Rd., Taipei, , , Taiwan
Keywords: sample size ; margin ; noninferiority
Abstract:

Before a new drug launches to the market, approval steps from the authority are needed and considerations in proving the efficacy and safety are the most important procedures. Superiority design is commonly used. Recently, due to effectiveness issues such as safety or economical considerations, noninferiority design is widely adopted in clinical trials especially when the comparison drug was proven to be active efficacious. Noninferiority is quoted if the efficacy effect of a testing drug is not worse than a comparing drug by a certain margin. The definition of this margin is subject to the facts from previous trials and investigators decisions. A few statistical contributions to margin were proposed previously, such as the 50% rule (CBER, 1998, 1999). These proposed margins preserve some statistical properties from previous documented trials, which is important when conducting a registration trail. In this study, we consider sample size issues using historical margin information in conducting a noninferiority study. Comparisons among few methods using simulated data will also be presented.

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