Clinical Trials
Fundamental issues with non-inferiority testing in controlled trials discussed
Published in Medical Letter on the CDC and FDA, March 30th, 2003
According to a study from the United States, "In an active controlled non-inferiority trial without a placebo arm, it is often not entirely clear what the primary objective is. In many cases the considered goal is to demonstrate that the experimental treatment preserves at least some fraction of the effect of the active control. The active control effect is a parameter, the value of which is unknown."
"To test the hypothesis of effect preservation, the classical confidence interval approach requires specification of a non-inferiority...
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