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Using the partitioning principle to adaptively design dose-response studies
1Amgen Inc, Thousand Oaks, California, USA. xiangl@amgen.com
Abstract:
An adaptive two-stage design is proposed for dose-response studies to find the minimum effective dose. The procedure is conducted in a stepwise fashion based on the partition testing principle with familywise error rate controlled strongly. We examine a wide dose range vs. a placebo in the first stage. Then an interim analysis is conducted with potential modification of design features of the experiment. Ineffective and/or unsafe dose treatments are terminated, and selected doses are further investigated in the second stage. Inference is based on a pre-chosen conditional error function. Several conditional error functions are discussed and compared.
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