[The Current Status and Issues of Investigator-Initiated Clinical Trials in Japan]

With the enforcement of the revised Pharmaceutical Affairs Law in 2003, physicians and dentists are now able to plan and conduct the"investigator-initiated"trial, whereas previously only companies were allowed to conduct such clinical trials. Although the number of investigator-initiated trials is increasing year by year, the high cost of conducting such trials and the difficulty of obtaining funds to cover the high cost are obstacles to their realization. In addition, the purpose of investigator- initiated clinical trials is to obtain approval for a drug or treatment, but in reality, there are many investigator -initiated clinical trials that do not aim for approval, and in some cases, the only difference between investigator-initiated clinical trials and specific clinical research is the approval status of the drug to be used in trials. In this article, the author will outline the current status and problems of investigator-initiated clinical trials in Japan in the midst of globalization of drug development, including the author's personal views.