[Role and Applicability of Spontaneous Reporting Databases in Medical Big Data].

In recent years, a variety of medical information has been digitized, and hence, various medical big data have become available. Spontaneous reporting databases are a part of the medical big data. In Japan, the Pharmaceuticals and Medical Devices Agency has developed the "Japanese Adverse Drug Event Report (JADER) database" which has been available since 2012. Thus, everyone can publish safety signal information based on the results of disproportionality analysis using the spontaneous reporting database. Since the release of JADER, many researchers and healthcare professionals are interested in it, and many reports have been prepared using JADER. Although we tend to focus on the fact that it is a publicly available database with many cases, it also has various limitations such as lack of the denominator information, under-reporting, and reporting biases. Detected signals do not necessarily imply a causal relationship between the drug and adverse event. In the "Guideline on good pharmacovigilance practices (GVP) Module IX by European Medicines Agency", signal detection is the first step in the signal management process. Signal detection alone does not complete pharmacovigilance activities. It is important to understand that spontaneous reporting databases are not only for researchers but also for those who are considering to apply them to clinical work by referring to research using these databases. In this symposium review, I will discuss the role and applicability of spontaneous reporting databases in medical big data.