Practice of Post-Marketing Database Study Using MID-NET^®

Abstract

Amendment of Good Post-marketing Study Practice in Japan in April 2018 allowed the selection of post-marketing database study as an additional pharmacovigilance activity. Daiichi Sankyo Co., Ltd. started to conduct a post-marketing database study since 2018, and currently conducts 6 studies. Through these results, it was found that some merits of the post-marketing database study compared to the conventional use-results survey were that: 1）It is not required the physicians’ effort to write down case cards 2）It is possible to shorten the time from data acquisition to the initiation of the analysis 3）It is possible to reduce costs and 4）It is possible to mitigate a part of biases in the analysis.