PRognostic factor of Early Death In phase II Trials or the end of ‘sufficient life expectancy’ as an inclusion criterion? (PREDIT model)

Background Optimizing patient selection is a necessary step to design better clinical trials. ‘Life expectancy’ is a frequent inclusion criterion in phase II trial protocols, a measure that is subjective and often difficult to estimate. The aim of this study was to identify factors associated with early death in patients included in phase II studies.