New paradigm in dose-finding trials: patient-specific dosing and beyond phase I.

摘要: We propose a new paradigm for the clinical evaluation of cancer therapies. It entails adjusting search optimal dose on basis measurable patient characteristics that may be predictive adverse responses to treatment, and extending this beyond phase I into phases II III. provide examples (a) how fine-tuning involve utilization patient-specific attributes obtain personalized treatment regimen, (b) novel methods design can used update working conduct III trials. These should interpreted as an enticement development implement proposed paradigm.