抽象的な

Analysis of the Current Clinical Research Management System of Investigator Initiated Trials in China

Ye Cao, Xin Wang, Yu Cao, Fuyu Song, Silvia Minelli, Jibin Li, Kexin Li, Minghuang Hong

Objective: With the rapid increasing clinical trials in China in recent years, there has been rising concern on the management of investigator initiated trials. Compared with the trials sponsored by pharmaceutical companies, IIT is facing practical challenges in China due to the lack of experience by investigator and immature regulatory circumstances. We conducted an internet-based survey to understand the overall picture of IITs management in China.

Methods: An internet-based questionnaire was developed and the staff of clinical trial offices from different types of hospitals was invited to provide response via mobile based App or online website in 2 weeks. We have collected the responses from the following aspects: administrative and governance infrastructure, ethical review, project management, funding resources and research staff management.

Results: From December 8 to 20, 2016, a total of 259 responses were collected from the staffs that are mainly responsible for the clinical trial management and scientific research based in the different clinical facilities.

Conclusion: In China, three key factors are important to improve the management on IITs: funding support, staffing resourcing and regulatory guidance.