Tailored Multi-Strata Designs for Early Phase Clinical Trials
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*Beat Neuenschwander, Novartis Pharma AG  Satrajit Roychoudhury, Novartis Pharmaceutical 

Keywords: Exchangeability, Multi-strata

In clinical trials statistical challenges arise when data from different strata (e.g. trials, regions, populations, cancer type) are available. Statistical inference for strata-specific parameters can be challenging due to the uncertainty about whether or not (or to what degree) pooling across strata is appropriate. We propose EXNEX, a tailored and robust multi-strata approach that allows for different degrees of exchangeability (EX) as well as non-exchangeability (NEX) across strata parameters. The proposed methodology will be discussed with examples from phase I and II Oncology trials.