Japan has started fleshing out the details of a programme, aimed at encouraging more doctors to participate in clinical trials and revitalising the clinical research sector in the country.
The Ministry of Health, Labor and Welfare has recognised for some time that there are problems with the clinical research environment in Japan, including few incentives for patients to be involved in trials, low incentives for clinical research associates and clinicians to take part, and too few centres to carry out studies in accordance with Good Clinical Practice.
This led it to set up a three-year plan in 2003 to try to improve matters and, according to a review of this effort earlier this year, is showing the first signs of success – the number of applications to start clinical trials rose by nearly 40% over the three-year period (from 360 to nearly 500 last year).
In addition, the number of hospitals registered to take part in Japan’s clinical trial network rose from 270 to 1,170, and the number of clinical research coordinators passing through training was up 40% (from 3,180 to 4,520), although the latter represented a missed target as the aim had been to bring 5,000 CRCs through the programme.
Despite the progress, the MHLW believes there is still much more work to be done, and earlier this year set up a new panel to continue the programme into a second three-year phase, with the objectives of improving the training of clinical investigators, CRCs, institutional review board members, data managers and bio-statisticians.
There are still too few Japanese physicians wishing to participate in clinical trials, according to Haruko Yamamoto of Japan’s National Cardiovascular Centre, a member of the MHLW's new panel. There should also be a drive towards training more full-time CRCs, as these currently account for just 10% of the total number of CRCs working in Japan. The panel is chaired by Hideo Kusuoka of the Institute of Clinical Research at Osaka National Hospital.
One solution proposed by the committee is the implementation of an incentive scheme, so that doctors taking on the responsibility of clinical trials would be awarded points under Japan’s system of physician accreditation, and also confer advantages in securing research funding.
But the latter suggestion has met with some opposition, as there is a concern that there could be a conflict of interest if doctors have too great a financial incentive to recruit patients into studies.
Kicking off the programme will be a survey of the number of investigator physicians, CRCs and data managers across large hospitals and clinics who will take part in clinical trials during the months of July and August. The initial findings of the programme are due to be made available in March 2007.
The plan also includes a number of items intended to educate the Japanese public about the importance of clinical trials, provision of easier access via the Internet for patients to up-to-date information on drugs undergoing clinical development, and making sure pharmaceutical companies understand the importance of notifying the patients who participated in studies of the approval status of the new drug, according to the Japan Pharmaceutical Manufacturers Association.