Publication of case reports and the registration of clinical trials/research

Case of robot-assisted surgery

Abstract

The Clinical Trials Act, which required legal proceedings for clinical research to evaluate the safety and effectiveness of drugs and medical devices, was enforced in Japan in 2018. Although intervention trials of advanced operative procedures were not covered by the Clinical Trials Act, it was noted in the addendum to the Act that action was necessary for those trials to provide evidence of effectiveness and safety. In this report, we took up robotic surgery as an example of an advanced operative procedure and examined the current status of trial registrations at the International Clinical Trial Registry Platform (ICTRP) of the World Health Organization and Clinical Trials. gov of the United States National Library of Medicine to consider future amendments to the Clinical Trials Act in Japan. Furthermore, we compared the number and transition of trial registrations to pharmaceutical approval and the reimbursement of health insurance costs. We found 188 trials of robotic surgery at ICTRP and 131 at ClinicalTrials.gov, which had increased from 2010 and decreased after 2018. Around 2007, similar trials in Western countries such as the United States and France appeared, but after 2011, trials in Japan and China increased at ICTRP. The increasing number of trials in Japan was associated with the timing of pharmaceutical approval and the reimbursement of health insurance costs. However, there was a time lag between feasibility trials and trials evaluating the effectiveness and safety, and institutional design was necessary to guarantee patient safety and trial effectiveness for that interval.