DOSE-FINDING STRATEGIES INVOLVING INTERIM ANALYSES AND UNBALANCED TREATMENT ALLOCATION

Dose finding studies usually require the application of multiple test procedures (MTP). A variety of procedures is available for data analys es. Focusing on testing only subset hypotheses of interest requires on ly limited alpha-adjustment. Specific strategies based on MTP, in part icular closed test procedures, which also consider dropping dose group s and unequal group sizes, lead to substantial reduction in total samp le size. Of course, strategies discussed here can be extended to compa risons of more than five groups, and they may be generalized to cover equivalence tests, too. For example, one may want to demonstrate thera peutical equivalence of two dose regimens like b.i.d. and o.d. adminis trations of the drug.