JSM 2011 Online Program

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Abstract Details

Activity Number: 19
Type: Topic Contributed
Date/Time: Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #302250
Title: Reducing Cost in Clinical Trial Data Monitoring Using Simulation
Author(s): Lan Pan and Peter Lam*+ and Joseph Bero
Companies: Boston Scientific Corporation and Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborogh, MA, 01752, USA
Keywords: clinical trial ; data monitoring ; partial monitoring ; simulation
Abstract:

In large scale clinical trials with lengthy follow-up, data monitoring is critical but costly. It is important to examine the efficiency of data monitoring. This paper presents a method of partial monitoring to reduce reporting error to an acceptable level by targeting the monitoring where it can be most effective. The efficiency of this target monitoring will be checked through simulations. The assumptions for exploring this method are similar to basic factors of true clinical trials, so it can be used in a real clinical settings.


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