Abstract
Treatment outcome studies have been the main part of post-marketing surveillance (PMS) in Japan, but it seems burdensome for medical practitioners to conduct them due to the lack of support compared to that for clinical trials. The Ministerial Ordinance on Good Clinical Practice for Drugs (Ordinance of the Ministry of Health and Welfare No 28 of March 27, 1997, GCP) applies to clinical trials to ensure a certain level of quality of clinical trials. But there have been no reports investigating the quality of treatment outcome studies in medical institutions. Therefore, we conducted a questionnaire survey of medical representatives (MR) on the treatment outcome study practice in medical institutions. The result shows that MRs are not satisfied with the speed of the studies, but with the quality in general. It also shows that physicians sometimes refuse to fill in or correct the case report form due to their busy practice, and it is suggested that not only medical practitioners but MRs have been overloaded with conducting treatment outcome studies. Known/mild adverse events are more often missed from reports, even though such event names are pre-specified in the form. It is important to plan treatment outcome studies focusing on important safety issues, which will lead to improvement of the studies as a whole. The quality of treatment outcome studies is expected to improve if their burden of preparing the report forms is reduced by focusing on important matters for investigation.
