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 analyses. Focusing on testing only subset hypotheses of interest requires only limited alpha-adjustment. Specific strategies based on MTP, in particular closed test procedures, which also consider dropping dose groups and unequal group sizes, lead to substantial reduction in total sample size. Of course, strategies discussed here can be extended to comparisons of more than five groups, and they may be generalized to cover equivalence tests, too. For example, one may want to demonstrate therapeutical equivalence of two dose regimens like b.i.d. and o.d. administrations of the drug.
Wargenau
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FOCUS Clinical Drug Development GmbH, Statistics Unit, Neuss, Germany.
D000704:Analysis of Variance; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D004305:Dose-Response Relationship, Drug; D004358:Drug Therapy; D006801:Humans; D008954:Models, Biological; D012107:Research Design; D018401:Sample Size; D012680:Sensitivity and Specificity