Inadequate cancer pain management in Italian clinical trials.

Pain treatment in Italy is far from being optimal. In order to improve this situation, the reporting of a complete assessment of pain in the clinical record became compulsory by law. Pain-related cancer protocols (143) were selected from the National Monitoring Centre of Clinical Trials Database and reviewed. Our data indicate that pain management is not being reported as it should be: treatment has been taken into account in only 36.4% of the protocols, and assessment in 37.1%. Furthermore, breakthrough cancer pain has never been reported. The main aim of cancer therapy is obviously control the disease, however Ethics Committees should pay close attention to pain therapy when evaluating clinical protocols.