薬理と治療

Abstract

The objective of the present study was to find the current characteristics of deviations in medical device clinical trials in Japan. 　For medical devices approved from April 2011 to December 2020, we surveyed the summary of Japanese clinical trials published in the application document summary. We summarized the deviations from the protocol and GCP practice. 　Forty summary reports mentioned the evaluation results of serious or significant deviations. Eighty‒nine serious or significant deviations occurred in 20 clinical trials against 2621 registered examinees（3.4 cases/100 examinees）. 　Thirty‒three summary reports mentioned the detailed evaluation results of deviations included deviations other than significant or significant deviations. In total, 801 deviations occurred in 30 clinical trials against 2151 registered examinees（37.2 cases/100 examinees）. One of the major causes of frequent deviations might be restrictions on the use of familiar drugs or operation procedures. The other might be the setting of allowance in the protocol that did not reflect actual clinical practice. Regarding the data handling of the deviations related to the measurement time, there existed not a small case that the efficacy and safety data sets included those data. In addition, the frequency of deviations was high during the examination on the discontinuation or discharge from the hospital. 　We showed the current characteristics of deviations in medical device clinical trials in Japan. We believe that these results provide helpful information for preparing a protocol and conducting risk‒based monitoring in medical device clinical trials.（Jpn Pharmacol Ther 2022；50 suppl 1：s27‒36）