Activities

The Global Clinical Trial Development Project was set up to promote a system that can provide responses to and support for a wide range of activities, including planning and designing global clinical research and trials, and regulatory actions and negotiations from the perspective of future global development. Toward this aim, the project includes the selection of a headquarters for global clinical research/trials among the core clinical research hospitals in medical law with central roles in leading clinical research as defined by the Medical Act and the organization of a system to conduct and support such activities. Such activities will aim to promote the implementation of multinational clinical research/trials centered on clinical research core hospitals in Japan.^*

* From “Call for proposal for ‘Global Clinical Trial Development Project’ for FY2016” on the Japan Agency for Medical Research and Development website. “Solicitation: Global Clinical Trial Development Project for FY2016”.

Aims

The Global Clinical Trial Development Project headquarters will respond to and support a range of activities, including planning and designing multinational clinical research and trials, and regulatory actions and negotiations from the perspective of future global development in collaboration with other core clinical research hospitals, thereby realizing the mission that multinational clinical research and trials initiated by physicians in Japan in particular should play a central role in such global activities.

Expected outcome

Ongoing engagement in and support of multinational clinical research and trials (in particular-initiated types in Japan in particular) and the structuring of relevant systems are expected in the context of differences in international regulations centered on ICH-GCP^* as the principle.

^* Includes ISO14155:2011 for medical devices

Conducting of/support for global multi-regional clinical research and trials ^*

(a) At least one investigator-initiated global clinical research or trial at our own facility per year

(b) At least one investigator-initiated global clinical research or trial at another facility in Japan per year

^*The scope of the proposed engagement/support include consultations for specific steps toward initiation of trials