Abstract #301465

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JSM 2003 Abstract #301465
Activity Number: 380
Type: Luncheons
Date/Time: Wednesday, August 6, 2003 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301465
Title: Statistical Issues in Medical Device Studies - THIS LUNCHEON IS SOLD OUT
Author(s): Gregory Campbell*+
Companies: Food and Drug Administration
Address: Center for Devices & Radiologic Health, Rockville, MD, 20850,
Keywords: clinical trials ; therapeutic devices and implants ; diagnostic tests ; placebo effect ; microarrays ; Bayesian statistics
Abstract:

Studies of new medical devices pose a number of interesting and challenging issues for statisticians. The widely different technologies, from heart valves, stents, and artificial skin to spinal fixation devices, breast implants, and mammographic equipment, create continual statistical challenges. Therapeutic devices and implants often cannot be masked, and sometimes there is no concurrent control. Diagnostic products from imaging equipment to genetic tests and microarrays require an entirely different set of statistical techniques for design and analysis. Bayesian approaches for clinical trials will also be discussed.

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Revised March 2003