JSM Activity #12

Back to main JSM 2001 Program page


Activity ID:  12
Title Room
Design and Methodological Issues for Noninferiority and Equivalence Trials M-London/Zurich
Date / Time Sponsor Type
08/05/2001    2:00 PM  -  3:50 PM Biopharmaceutical Section*, ENAR Topic Contributed
Organizer: Gang Chen, CDER/FDA
Chair: George Chi, Food and Drug Administration
Discussant:  
Floor Discussion 3:40 AM
Description

Recently, there have been extensive discussions on non-inferiority trials (active-control trials) in the evaluation of new treatments. This session will discuss some important design and methodological issues in non-inferiority trials. A non-inferiority trial is designed to show that the efficacy of an experimental drug is no worse than that of the active comparator. The major concerns in non-inferiority trials are the selection of a margin and type I error control.
  301653  By:  Gang Chen 2:05 PM 08/05/2001
Issues in a Non-inferiority Trial Design

  301654  By:  Mark Rothmann 2:30 PM 08/05/2001
Comparison of Non-inferiority Methods for Mortality Trials

  301655  By:  Ning Li 2:50 PM 08/05/2001
Application of Non-inferiority Analysis Methods in NDA Submissions

  301656  By:  Eric  Holmgren 3:10 PM 08/05/2001
Establishing Equivalence by Showing that a Specified Percentage of the Effect of the Active Control Over Placebo is Maintained

JSM 2001

For information, contact meetings@amstat.org or phone (703) 684-1221.

If you have questions about the Continuing Education program, please contact the Education Department.

Revised March 2001