[Phase III trials in oncology]

The randomised trial is the best context for the assessment of any new molecule in oncology. The authors emphasize the methodological aspects of randomised trials and suggest strategies to be adopted in phase III trials, based on the newly orthodox concept of evidence-based medicine, while underscoring the need for context specific adaptations to increase relevance and specificity of sought endpoints, including other means of controlling adequately the clinical experiment without randomization (patient as his own control models). The authors also suggest certain strategic changes. For example, restrictive but relevant eligibility criteria may help decrease the number of patients needed without compromising statistical power as well as other strategies aimed at proving the efficacy of a new molecule without carrying out large trials, which are too long and costly.