Design Consideration for Simultaneous Global Drug Development Program

• Activity Number: 519
• Type: Topic Contributed
• Date/Time: Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Gang Chen*+
• Companies: J&J
• Keywords: MRCT ; adeptation ; type I error

Abstract

Due to the potential impact of ethnic factors on clinical outcomes, the global registration of a new treatment is challenging, and often requires more local trials in addition to a multi-regional clinical trial (MRCT) to support the efficacy and safety claim of the treatment. This issue has been addressed in ICH E5 and intensively investigated and discussed from different perspectives in last 10 years. In this talk, I will discuss the current SFDA and The Ministry of Health, Labor and Welfare of Japan (MHLW) regulations on the requirement for the local registration of a new drug. I will also share with you a novel method for the design consideration for a Simultaneous Global Drug Development Program (SGDDP). In the proposed method, a weighted combination of the information collected from both the target ethnic (TE) group and the non-target ethnic (NTE) group will be used to test the efficacy for the TE group. This method allows a rigorous control of the overall false positive (type I error) rate for the program at a given level and would provide the guidance of statistical design fulfill the regulatory requirement for local registration.