Abstract
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.
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Acknowledgements
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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Roth, K. (2010). Designs for Dose Finding Studies on Safety and Efficacy. In: Giovagnoli, A., Atkinson, A., Torsney, B., May, C. (eds) mODa 9 – Advances in Model-Oriented Design and Analysis. Contributions to Statistics. Physica-Verlag HD. https://doi.org/10.1007/978-3-7908-2410-0_24
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DOI: https://doi.org/10.1007/978-3-7908-2410-0_24
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Publisher Name: Physica-Verlag HD
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Online ISBN: 978-3-7908-2410-0
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