Comparisons between a new drug and active and placebo controls in an efficacy clinical trial.

ABSTRACT

D'Agostino and Heeren (DH) discussed the multiple comparison issues that arise in evaluating both sensitivity and efficacy in over-the-counter drug trials. We propose a general definition of sensitivity that includes DH's definition as a special case. We also propose a test for sensitivity that coincides with the MIN test of Laska and Meisner at one extreme but has the advantage of identifying specific drugs satisfying the sensitivity criterion when some fail to do so. We suggest that the test of Dunnett as well as an extension of it may be useful for the efficacy comparisons.