[Policies for clinical trials in cancer]

The importance of proper planning, organization, and design of cancer clinical trials along with the need for a clear and detailed protocol cannot be overemphasized since these factor are crucial in determining the eventual success of a study. Of course, all clinical trials should be ethically and scientifically justified. In this context, we organized two committees, Protocol Review Committee and Monitoring Committee, for the cancer clinical trials conducted in a study group performing a project, "study of multidisciplinary treatment of solid cancer", supported by a Grant-in-Aid (62 S-1) for Cancer Research from the Ministry of Health and Welfare, in order to judge ethical and scientific problems of the protocols as well as the interim and final analyses of results. Here, we described stipulations of the Committees for proper design and conduct of the protocol study.