JSM Activity #35


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Activity ID:  35
Title
* Statisticial Issues with Medical Devices
Date / Time / Room Sponsor Type
08/11/2002
4:00 PM - 5:50 PM
Room: H-Petit Trianon
Biometrics Section*, Biopharmaceutical Section*, ENAR Topic Contributed
Organizer: Lilly Yue, Food and Drug Administration
Chair: Greg Campbell, Food and Drug Administration
Discussant:  
Floor Discussion 5:45 PM
Description

Statistical issues pertinent to the design and analysis of studies to evaluate medical devices are presented.
  300722  By:  Gene A. Pennello 4:05 PM 08/11/2002
Sample Size for Repeated Measures Designs of Method Comparisons

  300696  By:  Chang S. Lao 4:25 PM 08/11/2002
Statistical Methods in Monitoring Adverse Events for Medical Device Postmarketing Surveillance Studies

  300666  By:  Marina  Kondratovich 4:45 PM 08/11/2002
Propensity Scores in Receiver Operating Characteristic (ROC) Analysis

  300834  By:  Michael  Lu 5:05 PM 08/11/2002
Defining Equivalence Margin in IVD Equivalence Studies

  300971  By:  Sarah J.H. Kogut 5:25 PM 08/11/2002
Choice of Control Group in Therapeutic Device Trials

JSM 2002

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Revised March 2002