MURAGAKI Yoshihiro    Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine    Position   Visiting Professor
Language	Japanese
Title	Protocol design of the clinical trial and approval process of therapeutic medical devices in the United States.
Conference Type	Nationwide Conferences
Presentation Type	Speech
Date	2008/10/31
Society abstract	日本コンピュータ外科学会誌 10(3),355-356 2008
Summary	Abstract: Japanese companies hesitate to develop new therapeutic medical devices, as opposed to diagnostic machines, because of potential financial and social risks. Also, Japanese academic institutes are enthusiastic about reporting new methods or theories to top journals but not about bringing their prototypes to the market. Consequently,the import excess from abroad is about50billion dollars and the problem of device lag occurs. To improve this situation, we should decrease various risks for all players placing medical devices on the market. In particular, premarket approval is a most difficult and most expensive step in the development process; however, design and evaluation of clinical trials of devices, one aspect of regulatory science, has not been well established compared to the equivalent process for drugs. Here we report the actual design of the clinical trial and decision making process of the federal Food and Drug Administration (FDA) for approved therapeutic medical devices. Amazingly, most of the cases did not use ongoing control patients and only a few cases showed that a new device is superior both in efficacy and safety compared to a control therapy. In conclusion, the trial design and evaluation for new devices are different from those for drugs and we should think carefully about controls and endpoints to evaluate the value of each device.