Clinical trial design issues: Session 1

摘要

Anticancer therapeutic intervention in patients with solid tumours still relies on the necessity of empirically treating many patients to obtain benefit for a limited few. The activity of a given drug in patients with advanced cancer is the result of a pharmacodynamic interaction with a pathway. Such putative pathways must be both prevalent in the cancer cells and relevant to the process of uncontrolled cell proliferation. Several examples have clearly demonstrated the value of measuring the molecular target and using it as inclusion criteria for clinical trials. Adaptive trial designs and the definition of clinical surrogate end-points can be helpful tools to further improve clinical drug development. In general goo go decisions must be established prospectively.