2020 年 51 巻 5 号 p. 277-280
Objective: There is an increase in post-marketing studies (PMS) that require ethical review of matters such as informed consent from patients and the questionnaire used. In order to present the problems related to PMS faced by medical institutions, we investigated the contract status of the PMS at Tokai University Hospital and the PMS that required ethical considerations and reviews.
Methods: We classified the PMS contracts received by the Pharmaceutical Committee at our hospital from April 2014 to March 2018 according to the type of PMS and calculated the summary statistics. We also calculated the contents of PMSs that required ethical review.
Results: The PMS contracts received at our hospital were as follows: 77 single cohort studies, 74 specific cohort studies, 90 adverse event reports, and two others. In 16 PMS protocols, there were problems with the method of describing the study items, obtaining informed consent from patients, and handling personal information. Among them, seven were related to acquisition of informed consent forms and six were related to conduct of questionnaire survey.
Conclusion: As solutions to the problems, standardization of the contents and methods of descriptions in PMS protocols, clear distinction between the investigation items for re-examination and the additional investigation items in PMS protocols, descriptions of the purpose and reason of the investigation, and revision of laws and regulations for reusing the contents as materials for submission to regulatory bodies overseas.
In order to realize the above, it is important to develop a better environment for conducting PMS taking into consideration the current situation, under the guidance of the government and with collaboration among the pharmaceutical industry, medical institutions, and other industrial organizations.
