American Statistical Association
New York City
Metropolitan Area Chapter

Mailman School of Public Health
Columbia University
Department of Biostatistics Colloquium



THE NONINFERIORITY TRIAL:
A HORSE OF A DIFFERENT COLOR

by

Professor Rick Chappell
Departments of Biostatistics and Medical Informatics & Statistics
University of Wisconsin at Madison


Abstract

Equivalence trials are experiments which attempt to show that one intervention is not too much inferior to another on some quantitative scale. The cutoff value is commonly denoted as Delta. For example, one might wish to show that the hazard ratio of disease-free survival among patients given an experimental chemotherapy versus a currently approved regimen is Delta = 1.3 or less, especially if the former is thought to be less toxic than or otherwise advantageous over the latter.

Naturally, a lot of attention is given to choice of Delta. In addition to this, I assert that even more than in superiority clinical trials the _scale_ of Delta in equivalence trials must be carefully chosen. Since null hypotheses in superiority studies generally imply no effect, they are often identical or at least compatible when formulated on different scales. However, nonzero Deltas on one scale usually conflict with those on another. For example, the four hypotheses of arithmetic or multiplicative differences of either survival or hazard in general all mean different things unless Delta = 0 for differences or 1 for ratios. This can lead to problems in interpretation when the clinically natural scale is not a statistically convenient one.


Date: Thursday, October 18, 2007
Time: 4:00 - 5:00 P.M.
Location: Mailman School of Public Health
Department of Biostatistics
722 West 168th Street
Judith Jansen Conference Room
4th Floor - Room 425
New York, New York

RESERVATIONS ARE NOT REQUIRED

Refreshments will be served at 3:30 P.M. in the
Biostatistics Conference Room (R627).


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