MHLW's New 5 Yearly Clinical Trial Activation Plan
‘New 5 Yearly Clinical Trial Activation Plan,’ developed jointly by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) and MHLW, has been implemented since FY2007.
JMACCT is committed to contribute to achieving the goals of the plan by the following activities as well as by promoting cooperation among the government, industry and medical institutions.
JMACCT’s contributions to the New 5-Year Plan
- Promotion of cooperation among core research centers and major trial institutions
The main features of the plan include ‘core research centers’ and ‘major trial institutions.’ Designated medical institutions will take initiatives in improving the framework and infrastructure for clinical trials and researches. JMACCT will provide such institutions with necessary support to promote cooperation and communication among them.
- Standardization of forms
To reduce the paperwork burden on industry and improve clinical trial efficiency, JMACCT set up a working group to develop standardized document templates and served as a secretariat for the group. The templates developed by this working group were endorsed by MHLW as per the announcement dated 21 December 2007. JMACCT is promoting consistent utilization of these templates by sponsors and medical institutions and is currently developing software to assist data entry.
- Cooperation between core research centers/major trial institutions and clinical trials networks
JMACCT will promote cooperation between core research centers/major trial institutions and MNCT/regional clinical trials networks.
- Support for training conducted by core research centers and major trial institutions
With the constant advancement of science, relevant laws and regulations are often revised and updated. For the conduct of clinical trials/researches, it is essential to be alert and up-to-date with the latest developments in the related fields. JMACCT provides support for necessary training conducted by medical institutions.
For more information on the ‘New 5 Yearly Clinical Trial Activation Plan,’ click here to visit MHLW’s website. (Available in Japanese only.)