【医療データベースの現状と課題】 2）PMDA における医薬品の安全性評価を目的とした医療情報データベースの薬剤疫学的利活用：MIHARI Project とMID‒NET

Randomized controlled trials have been usually used for drug evaluation of efficacy, but not of safety（e. g. increased risk of adverse events induced by a drug）. Evaluation of drug safety is mainly based on spontaneous reports of adverse events and pharmacoepidemiological research using huge medical information database. In this article, we describe progress and future direction of two projects about utilization of medical information for drug safety evaluation in Japanese pharmaceutical regulatory agency. One is the MIHARI Project which is a new framework for pharmacoepidemiological research using various database and the other is the MID‒NET(R) which is the new infrastructure for analysis of medical records data in many hospitals.