JSM 2004 - Toronto

Abstract #301402

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Activity Number: 123
Type: Luncheons
Date/Time: Monday, August 9, 2004 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301402
Title: Issues in Megatrials
Author(s): David H. Henry*+
Companies: Bristol-Myers Squibb Company
Address: 1095 Cornell Dr., Yardley, PA, 19067,
Keywords: clinical trials ; multicenter ; megatrial
Abstract:

Very large multicenter clinical trials (megatrials) pose many interesting and challenging issues for statisticians. These include not only statistical concerns, but also operational, data, and regulatory problems. We will identify pitfalls associated with each of these areas and discuss how statisticians have addressed these issues.

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Revised March 2004