薬理と治療

Abstract

Several surveys of the impact of the Clinical Trials Act have been previously conducted. However, they were mainly focused on pharmaceuticals, rather than on medical devices. We conducted two kinds of surveys in order to investigate the impact of the Clinical Trials Act on clinical research that uses medical devices. One was a call for opinions in the Japan Society of Clinical Trials and Research website （Period: October 1 to November 30, 2018）, and the other involved surveys and opinions from 12 Certified Clinical Trials Review Boards（CRBs）of the Clinical Research Core Hospitals（Period: August 21 to September 6, 2019）. The surveys showed concern that medical devices, which have significantly different characteristics from those of pharmaceuticals, were nevertheless, treated the same way. Medical devices are extremely diverse, and it is difficult to secure human resources capable of responding to them in each CRB and, therefore, to review them all. It was also desired to prepare guidance and support tools（like flowcharts）to facilitate judgments, and to implement informational activities. The Clinical Trials Act was designed centered on pharmaceuticals and does not necessarily correspond to the characteristics of a wide variety of medical devices. In clinical research using medical devices, there is strong demand for a more appropriate institutional design that covers clinical research based on their characteristics, such as the risk classification of medical devices.