New plan for Japan clinical trials

The Japanese Ministry of Health, Labor and Welfare's new panel to establish a mid-term plan for facilitating clinical trials in Japan, which was set up on June 29, has started to discuss how it proceeds. Before entering the discussion, Hideo Kusuoka, vice president of National Hospital Osaka Medical Center, was elected chairman of the panel, reports the Marketletter's local correspondent.

First of all, an MHLW official, as the secretariat for the panel, evaluated the achievement in implementing the original three-year plan (2003-2005) for facilitating clinical trials, stating that the number of notifications for studies conducted increased 38% from 361 in 2003 (when it started) to 497 in 2005 and the number of registered hospitals in the large-scale clinical trial network in Japan rose 46% from 273 in 2003 to 1,170 in May this year, while the total for clinical research coordinators who completed the CRC training was up 42% from 3,178 in 2003 to 4,524 in 2005 (the targeted goal: 5,000).

According to data compiled by the Japan Pharmaceutical Manufacturers Association, the time between the application to conduct clinical trials filling and that of completing case reports was reduced 29 days from 555 days, on average, in 2003 to 526 days in 2004.