JSM Activity #151

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Activity ID:  151
Title Room
Statistical Issues in Medical Device Clinical Studies H-Walton
Date / Time Sponsor Type
08/07/2001    8:30 AM  -  10:20 AM Biopharmaceutical Section*, ENAR, Section on Statistics in Epidemiology* Topic Contributed
Organizer: Lilly Yue, U.S. Food and Drug Administration
Chair: Gregory Campbell, FDA, Center for Devices & Radiologic Health
Discussant:  
Floor Discussion 10:15 AM
Description

Studies designed to evaluate the safety and effectiveness of medical devices offer unique challenges compared to pharmaceutical products and require innovative thinking. This session provides both Frequentist and Bayesian approaches to medical device studies and includes presentations made by professionals from industry and the FDA. Topics include precision estimation, discrepant resolution/imperfect reference, repeated-measure design, competing risk modeling and prior distributions.
  301636  By:  Gene Pennello 8:35 AM 08/07/2001
Estimating the Precision of Monitoring Devices

  301637  By:  Jim Garrett 8:55 AM 08/07/2001
Estimating the Performance of a Diagnostic Device Using an Imperfect Reference Method: Some Clinical Trial Design and Analysis Issues

  301635  By:  Chang Lao 9:15 AM 08/07/2001
Application and Analysis of Repeated-Measure Design in Medical Device Clinical Trials

  301638  By:  Susan Zhou 9:35 AM 08/07/2001
Analyses of Current Administrative Cohort Data Using Competing Risk Models

  301633  By:  Telba Irony 9:55 AM 08/07/2001
Choosing an Appropriate Prior for Bayesian Analysis of an Experimental Device

JSM 2001

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Revised March 2001