Current regulatory systems for clinical trials in Japan: Still room for improvement

Abstract A main characteristic of the regulatory environment for clinical trials in Japan is that governmental regulations only apply to trials required for the approval of drugs or medical devices. Investigator-initiated clinical trials outside this registration scheme, such as large-scale trials to establish evidence for already approved drugs, are conducted based on government guidelines without corresponding laws. The Japanese adoption of Good Clinical Practice in 1997 and the governmental clinical trials vitalization plans instituted in 2003 have led to the improvement of infrastructure for registration trials, and this has in turn improved registration trial speed and quality. Global trials, rather than strictly domestic trials, are now prevailing. In contrast, problems associated with investigator-initiated trials conducted outside registration trial requirements were recently exposed by a scandal concerning a study of the anti-hypertensive drug valsartan. After the drug was launched, secondary benefits were reported in several academia-initiated clinical trials; these results proved to be fraudulent and the articles were retracted. This scandal threatens the reputation of Japanese drug trials and highlights the lack of scrutiny such trials have in terms of the potential conflicts of interest. To combat this issue, Japan has begun to establish new guidelines and a regulatory infrastructure to enhance the reliability of investigator-initiated clinical trials.