[Current status and problems in clinical trial for new anticancer drug in Japan].

Results of clinical trials for 28 anti cancer drugs in 20 pharmaceutical companies were analyzed to describe current status and problems in clinical trial for new anticancer drug in Japan. Phase I studies have been carried out in one to 19 institutes (median; 12), and in the period of 4 to 35 or more months (median; 13 months). Median number of patients entered into phase II studies was 2.9 per institute. Out of 21 drugs which finished the clinical trial, 4 were approved, 6 were made an application for approval, and 11 were discontinued the clinical development. Following problems are arisen in clinical trial for anticancer drug in Japan. Decision network for clinical development of new drug should be organized. Development of derivatives should be prudently done because it is difficult to overcome the parent product in efficacy. Phase I institutes for new anticancer drug evaluation should be designated by authority. Decision of sample size, patient selection, quality control, and informed consent are critical problems in clinical trials for new drug.