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 e ect of an experimental treatment.
Parole Chiave: 
Analysis prior, Design prior, Sample size determination, Skew normal distribution
Tipo di pubblicazione: 
Rapporto Tecnico
Codice Pubblicazione: