Three-Year Plan for Promotion of Clinical Trials Unveiled in Japan

The Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science, and Technology (MECSST) in Japan jointly unveiled their “Three-Year National Drug Clinical Trial Action Plan” on April 30, 2003. The plan, which will run from 2003 to 2005, was a result of previous studies done on improving clinical trials in Japan including the “Vision of the Pharmaceutical Industry” and “Outline for Biotechnology Strategy” reports composed by the MHLW and the Japanese government.

The main goal of the three-year plan is to remedy the current “hollowing out of clinical trials” in Japan. Unlike other developed nations, the number of clinical trials has stagnated since the implementation of the new Good Clinical Practices in 1997. The government’s plan hopes to improve the current social and regulatory environment in Japan to promote greater numbers of clinical trials.

The five main areas of the plan include:

  1. The promotion of clinical trial networks
  2. The enhancement of clinical study systems at medical institutions
  3. Greater support for patient enrollment in clinical trials
  4. Reduction of burdens imposed on the pharmaceutical industry
  5. The advancement and promotion of clinical research in general

In order to promote clinical trials networks, the government has set aside a budget of 850 million yen (US$7.2 million) for 2004 and is planning to construct a large-scale network composed of a number of medical institutions. The government is also planning to enhance the medical trial system by training 2,500 new clinical research coordinators (CRCs) over the next three years, bringing the total number of CRCs to 5,000. By increasing the number of clinical trials conducted in Japan, the government hopes to bring the country back as an international contender in the areas of research and development and technological advancement in the pharmaceutical industry.