P. Brutti, F. De Santis, S. Gubbiotti, V. Sambucini
Single-arm two-stage designs for phase II of clinical trials typically focus on a binary endpoint obtained by dichotomising an underlying continuous measure of treatment ecacy. To avoid the resulting loss of information, we propose a two-stage design based on a Bayesian predictive approach that directly uses the original continuous endpoint. Numerical results are provided with reference to phase II cancer trials aimed at assessing tumour shrinking eect of an experimental treatment.
Analysis prior, Design prior, Sample size determination, Skew normal distribution
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