Improving the Interim Analysis Process in Adaptive Design Trials

• Activity Number: 408
• Type: Contributed
• Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Xiaoyin Fan and Mary Varughese*+
• Companies: Merck & Co., Inc. and Merck & Co., Inc.
• Keywords: Adaptive design ; Interim analysis ; Cycle time

Abstract

In adaptive design trials, the interim analysis (IA) is the vital step before adaptation takes place. From the quality and ethical perspectives, both accuracy and speed of the IA conduct are very important, especially in critical or confirmatory trials which involve formal data review by data monitoring committees (DMC). A strategic initiative project, ADAPT, at Merck & Co., Inc. is being conducted to promote and execute adaptive design trials. One of the topics is to reduce the IA cycle time without compromising the quality of the results. We will present the case of a task force using Six Sigma approach to streamline the IA process from the data management to the result delivery. A pilot study has shown the reduction of the timeline of IA from 23.5 days on average to 14 days.