1. Investigator Initiated studies Some data from Benchmarking of Clinical trials in Japan 18 Multi-National and Japanese companies benchmarked their clinical trial data Between 2000 and 2002, assuming all other companies are behaving as these 18 :  The number of trial sites increased 87%  The number of patients recruited increased 53%  The number of “0 patient” sites increased about 400%

2. 2000-02 Comparison of patient enrollment by site Source: CMR International Year enrolment completed 200020012002 Total Number of Sites93414901743 Total Number of Patients621987679512

3. Factors limiting large scale clinical trials in Japan The most significant factor limiting clinical research in Japan is the lack of good clinical research sites. To improve this requires 2 things: 1.Academic and professional recognition of research excellence 2.Resources to flow to the research centres  The most recent move in the UK was to prevent Universities keeping industry research funds. - The patients in the trial are treated and paid for by the Health Service. - Commercial research funds can build hospital and research site facilities  If sites cannot keep research funds then central funding is required