ABSTRACT
Objective:To promote clinical innovation and patent transformation, Ningbo First Hospital built a medical device innovation and transformation management information platform to optimize the supply of clinical innovation and transformation resources and explore a new path of clinical innovation and transformation management.Methods:A series of processes of medical device innovation research, patent declaration, and transformation were managed by the cloud data platform based on Springboot micro-service architecture. The functions and practices of the medical device innovation and transformation management information platform were elaborated on in detail, and the problems in the platform construction were discussed.Results:The medical device innovation and transformation management information platform has been accepted and recognized by clinical care, enterprises, and third-party agents for shortening the research and development and transformation time of innovative projects.Conclusions:The medical device innovation and transformation management information platform can promote the output and achievement transformation of clinical innovative projects.
ABSTRACT
Pharmaceutical regulatory schemes concerned with real world data have been changing remarkably in terms of both drug development and post-marketing.As for drug development, ICH proposed “GCP Renovation” , which includes modernization of E8 Guideline (General Consideration for Clinical Trials) and subsequent renovation of E6 Guideline (Good Clinical Practice). It covers pragmatic clinical trials, randomized controlled trials using patient registry data, and even observational studies using real world data. In the US, “The 21st Century Cures Act” refers to the proposal concerning speeding up the approval review by making clinical trials more efficient. In fact, there are some cases where real world data was used in the approval review of expanding the application. Also, in Japan, Clinical Innovation Network (CIN) plan was announced, and utilizing the natural history data like patient registry as the control group of clinical trials for the approval review is now under consideration.As regards post-marketing surveillance, “Conditional & Accelerated Approval” (October 20, 2017, Yakuseiyakushinhatsu 1020 No. 1) stated that post-marketing confirmation of validity of efficacy and safety using real world data, such as Medical Information Database Network (MID-NET) project and patients registries in CIN plan, is required to get the early approval. Moreover, “The Ordinance on Good Post-Marketing Practice” (October 26, 2017, MHLW Ordinance No. 116) newly provided “Post-marketing Database Study” , which is conducted by use of medical information database like MID-NET, and utilizing real world data for post-marketing safety monitoring began.