Dose-response studies are useful in Phase II and Phase III clinical trials to evaluate efficacy and toxicity of a drug in order to determine its effective and safe ranges. A zero dose is generally included as a control against which higher doses are compared. This naturally leads to multiple comparisons. The ordered nature of doses suggests the use of stepwise multiple test procedures. The purpose of this article is to give a brief overview of these procedures. In Section 11.2, we present step-down procedures for identifying the minimum effective dose (MinED). These procedures are applied to the problem of identifying the maximum safe dose (MaxSD) in Section 11.3. Examples are given in Section 11.4 followed by some extensions in Section 11.5. The paper concludes with a discussion in Section 11.6.
Was this article helpful?