The Pharmaceutical Affairs Law (currently the Pharmaceutical Affairs Law) was revised in 2002 to allow for the implementation of investigator-initiated clinical trials. Physician-initiated clinical trials are now available for the development of therapeutic drugs that are difficult for pharmaceutical companies to implement on their own, such as in fields where research is already being conducted at universities and other institutions, or in diseases where the number of patients is extremely small. However, in investigator-initiated clinical trials, “physicians,” who are the principal investigators, plan and conduct the clinical trials themselves, and the burden on physicians is extremely heavy, so there are certain hurdles to overcome in order to conduct investigator-initiated clinical trials. Regulations concerning investigator-initiated clinical trials have been revised to reduce the burden on physicians, and an environment that supports investigator-initiated clinical trials is being developed at universities and other institutions. However, conducting investigator-initiated clinical trials is not an easy task.
By supporting investigator-initiated clinical trials, FiveRings hopes to help provide more effective medical care to patients suffering from illnesses as soon as possible. Our staff members are working together to bring effective medicines to the bedside of patients suffering from illnesses.