Japan: PMDA clinical study collaboration

A study committee on clinical trials of Japan's Pharmaceutical and Medical Devices Agency has recommended the PMDA to aggressively participate in international collaborative studies, including Asian trials, and to collect and accumulate pharmacogenomic data in order to prepare for establishing methods for evaluating the latter. The committee, which was established in August 2005, has discussed imminent issues to improve the status of clinical trials in Japan.

The panel pointed out that it is important for the PMDA to: improve the infrastructure and circumstances of clinical trials in Japan; participate in international collaborative studies; and make clear the concept and views for designs and data of clinical trials for international collaborative studies in terms of approval review. In addition, the report points out that Japan should reflect some factors which are considered in clinical trial protocols when conducting international collaborative studies in order, for example, to specifically collect Japanese patient data in terms of proper dosage for its citizens.

The report also urged the PMDA to promote Asian collaborative studies by including a certain number of Japanese patients so that the Ministry of Health, Labor and Welfare can accept the clinical trial data without a bridging study data. To do so, the PMDA should support individual drug manufacturers trying to participate in the studies, the panel said.