Designs for Dose Finding Studies on Safety and Efficacy
In early phase clinical trials usually only the safety and tolerability of a new drug are investigated at first. We suggest a model with which safety, measured on a categorical scale, and efficacy, a binary response, can be evaluated simultaneously. Subsequently we derive locally optimal designs for this model. Additionally, we apply this model in a sequential approach and compare its features with approaches considering only one endpoint.
KeywordsOptimal Design Maximum Tolerate Dose Design Point Information Matrix Dose Escalation Study
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The author is very grateful to Rainer Schwabe (University of Magdeburg) and Thomas Schmelter (Bayer Schering Pharma AG) for their support.
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