Regulatory-required post-marketing database studies in Japan could be leveraged to assess important potential risks as well as identified risks

In Japan, PMDS are usually cohort studies with targeted safety objectives. Most studies currently target important identified risk rather than important potential risk and may not make full use of the advantages of PMDS that can include large populations, comparator groups, and that can assess the occurrence of rare adverse events. These results could be informative for pharmaceutical companies planning post-marketing studies as pharmacovigilance activities. Early public availability of PMDS protocols would promote improved study methodology and could potentially improve the scientific value of PMDS in Japan.