Preliminary study on the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of "government-application-industry-academia-research"
10.3760/cma.j.cn113565-20210329-00059
- VernacularTitle:"政用产学研"视角下药物临床试验机构与合同研究组织协同发展的初探
- Author:
Min KONG
1
;
Xi GAO
;
Xiaohui JI
;
Lusha ZHU
;
Jindong LI
;
Mei LIN
Author Information
1. 南通大学第五附属医院(泰州市人民医院)科研处，泰州 225300
- Keywords:
Government-application-industry-academia-research;
Clinical trial institution;
Contract research organization;
Collaborative development
- From:
Chinese Journal of Medical Science Research Management
2021;34(6):407-411
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of " government-application-industry-academia-research" , and facilitate faster and better conducting of clinical trials.Methods:Based the combination of literature review and the working practice in drug clinical trial management, problems existed during the implementation of clinical trials were summarized, and then the collaborative development of drug clinical trial institutions and Contract Research Organizations were discussed from the perspective of " government-application-industry-academia-research" partnership.Results:Problems identified during the implementation of clinical trials including uneven capacity of CROs, lack of effective supervision department and insufficient cooperation with clinical trial institutions, which resulted difficulties in sharing clinical trial resources and also negatively impacted the quality of clinical trials. Some proposals were offered in this article, including making good use of the " visible hand" of the government to strengthen the supervision of CROs, accelerating the construction of innovation alliance between clinical trial institutions and CROs, establishing the incentive mechanism of collaborative development and the talent team construction, strengthening the personnel professional training.Conclusions:The application of " government-application-industry-academia-research" model in clinical trials would promote the collaboration between drug clinical trial institutions and Contract Research Organizations, which play important roles in the development of clinical trials.
