2022 Volume 12 Issue 3 Pages 271-276
With the aim of recognizing the effect of recent drug pricing reforms in Japan on the global development strategy of new drugs, the state of Japan’s participation in multi-regional clinical trials (MRCTs) sponsored by major foreign-affiliated companies was investigated based on the information registered in ClinicalTrials.gov. While the number of MRCTs sponsored by the major foreign-affiliated companies has been nearly constant in the past decade, the number and proportion of MRCTs in which Japan participated have steadily increased. The proportion of Japan’s participation seemed slightly decreased in 2021, and it needs a longer follow-up to judge whether it is a temporary phenomenon. The state of Japan’s participation in MRCTs sponsored by major foreign-affiliated companies would serve as an appropriate indicator of any change in Japan’s position and investment priority in global new drug development, and it needs to be investigated continuously in the future.
