Abstract
Recently, there has been a growing trend in clinical development to utilize real-world data (RWD) to improve the efficiency of drug/medical device development. Especially, the use of RWD to generate real-world evidence (RWE) in regulatory approval is currently undergoing a period of great change with an increasing degree of active discussion. In Japan, RWE has been used in the control arms of clinical trials, observational studies, post-marketing surveillance, and public knowledge-based applications for regulatory approval. However, the exclusive use of RWE applications has still not been applied. In this paper, we summarize the history and the current situation of RWE and focus on the utilization for the purpose of regulatory approval. In addition, we will discuss the issues and perspectives for registry research in the utilization for regulatory approval in Japan.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
