[Current problems of early phase clinical trials for new anticancer agents in Japan]

The agreement of the International Conference of Harmonization (ICH) states that any pharmaceutical company shall be able to apply for new drug applications in any country or area. The new version of Good Clinical Practice (GCP) has changed the principal process and structure of clinical development of new drugs, and most medical institutions have experienced many difficulties in adapting to the new version of GCP. Pharmaceutical companies have moved the main area of investigation for their new drugs from Japan to Europe or the United States, and have decreased the number of early phase clinical trials in Japan. If this situation continues in Japan for long, it will without doubt cause a decline in the level of medical practice here. We must make efforts to establish a total system for the clinical development of anticancer agents in Japan, and maintain a place for young Japanese medical oncologists to participate actively in the establishment of effective new treatments for cancer patients.