Submission of written opinions (public comments) on the 2012 5-Year Plan to Stimulate Clinical Trials and Research
2012-03-09
On March 9th 2012, we submitted to the Ministry of Health, Labor and Welfare (MHLW) a set of written opinions (public comments) on the 2012 5-Year Plan to Stimulate Clinical Trials and Research.
This 5-year plan outlines measures to stimulate clinical trials and research, and follows on from the National 3-Year Clinical Trial Activation Plan enacted in 2003, and the New 5-Year Plan to Stimulate Clinical Trials enacted in 2007.
The 2012 plan covers two main points: becoming a further separate entity from the 9-year stimulation plan, and steps (innovation) towards creating revolutionary medicine and medical equipment from Japan.
Some of the plan's contents need to be addressed, such as proposals for a recognition and registration system for the Ethical Review Board, but there are also some problems as highlighted below:
Firstly, there are insufficient viewpoints on guaranteeing the rights of clinical trial subjects and putting clinical trials under the rule of law.
Secondly, many clinical trials rely on company funding. As a result, pursuing profit becomes a priority, not the patients or the real needs of the medical field. In terms of quality, a lot of clinical trials and research are problematic and unnecessary, while those that really are required for medical reasons aren't being carried out, and there are inadequate measures in place to deal with this problem.
It is important to include a viewpoint on how clinical trials and research that benefit patients can be stimulated further. Therefore, we submitted our opinions as per the following 10 points:
<Outline of opinions>
1. Establishing the rights of clinical trial subjects is the basis of stimulating clinical trials and research. We wish to point out that patients must be able to participate from the planning stage of clinical trials and research. Concerning the overall framework, any item related to the rights and ethics of trial subjects should be separate from point 2 ("steps (innovation) towards creating revolutionary medicine and medical equipment from Japan") and made into one separate item in the 2012 plan.
2. Concerning the 2013 revision of "Ethical Guideline for Clinical Research," these guidelines must be legislated, not simply amended. When investigating this, a place to discuss and organise items related to the protection of trial subjects in Japan and the relationship between GCP (Good Clinical Practice) and other guidelines must be established.
3. Regulations on the quality of clinical research must be established immediately, and be regulated when item 2 is made into a law.
4. The pre-registration of clinical research and trials should be compulsory, made more widely available to the public, and be regulated when item 2 is made into a law.
5. Despite the possibility of going against company profit, there must be a system which guarantees that researchers will, as a duty, make public the results of any research that they are part of. This must also be regulated when item 2 becomes a law.
6. A recognition and registration system for the Ethical Review Board and the Review Board for Clinical Trials should be looked into immediately. Networking also needs to be clear. It must be possible to search and retrieve such a system online
7. Any standards and investigative results must be made public, and any conflict of interest needs to be more tightly managed and controlled.
8. The creation of public funds for clinical research should be clearly explained.
9. Detailed explanations must be given on establishing university courses such as biostatistics and revising the core curriculum of medical education and the fostering of human resources.
10. Concerning the spread of educational activities among the public, the following are all necessary: drawing up guidelines for educational activities, thoroughly releasing information, registering clinical trials and research, and maintaining the law to protect clinical trial subjects.
