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Abstract Details

Activity Number: 279
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
Sponsor: IMS
Abstract - #305528
Title: Dose-Finding Studies with an Active Control
Author(s): Katrin Kettelhake*+ and Holger Dette
Companies: Ruhr-Universität Bochum and Ruhr-Universität Bochum
Address: Universitatsstrasse 150, 44780 Bochum, , Germany
Keywords: active control ; dose response ; dose estimation ; information matrix
Abstract:

In dose finding studies often several doses of a new compound were compared with a marketed standard treatment as an active control. Usually research has focused on experimental designs for placebo-controlled dose finding studies. Optimal designs for dose finding studies with an active control have not been considered much so far. For this kind of studies the statistical analysis can be formulated in terms of a mixture of two regression models. We present an approach to the problem of determining optimal designs for estimating the smallest dose achieving the same treatment effect as the active control. Additionally, we consider the information matrix which imply only the information about the new drug and show, that it is sufficient to know its optimality to conclude the optimality of the information matrix including also the information about the active control for several optimality criteria.


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