薬理と治療

Abstract

We surveyed the current status of serious adverse event（SAE）reports in the investigator‒initiated clinical researches conducted at Kanazawa University Hospital（KUH）and clarified the problems with their contents. We reviewed the SAEs whose first reports were submitted to the clinical research review board at KUH held in from December 2016 to March 2018. We assessed the SAE reports prepared according to the SAE standard operation procedure of KUH. Thirty‒two SAEs met the above criteria, and 8 of the 32 SAEs had one or two continued reports. Not all blanks were filled out in 9 final SAE reports. About 80％ of the 32 adverse events became SAEs by“hospitalization or prolongation of hospitalization.” About the outcome in the final SAE reports,“not recovery”and“unknown”were found in 4 reports and 3 reports, respectively. These included in the cases of the progression of malignancy or the primary disease and follow‒up by the other medical institutions. We found the definition of“start date of adverse event”was different in each clinical research. Based on the results of this survey, we make a sample to fill in the SAE report form. In conclusion, we reviewed the SAE report contents in the investigator‒initiated clinical researches and found some points to be improved, i. e., incomplete column, insufficient follow‒up, and inconsistent definition of the start date of the adverse event. Continuous reviews and improvements for reporting SAE are necessary.