JSM Activity #65

Back to main JSM 2001 Program page


Activity ID:  65
Title Room
* Issues Relating To Non-inferiority Studies in Active Controlled Trials H-Jackson
Date / Time Sponsor Type
08/06/2001    8:30 AM  -  10:20 AM Biopharmaceutical Section*, ENAR Topic Contributed
Organizer: S. Edward Nevius, CDER/FDA
Chair: Sue Jane Wang, FDA
Discussant:  
Floor Discussion 9:55 AM
Description

There seems to have an increasing trend that the pharmaceutical industry wants to claim efficacy of a new drug by showing non-inferiority to an active control or making an indirect comparison of the new treatment with a hypothetical (or putative) placebo using historical control data. There are many difficult statistical inferential issues in this area. This session is devoted to efficacy evaluation for a new treatment in an active control trial without a placebo group.
  301156  By:  Steven Snapinn 8:35 AM 08/06/2001
Discounting Historical Data in Non-inferiority Trials

  300686  By:  H. M. Hung 8:55 AM 08/06/2001
Non-inferiority Testing in Active Controlled Trials

  301366  By:  Janet Wittes 9:15 AM 08/06/2001
Active Controlled Trials: Sin or Syntax?

  303411  By:  Anders Kallen 9:35 AM 08/06/2001
Therapeutic Equivalence Trials - Do We Need Them?

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