摘要
Abstract
Objective To understand the current development status and existing problems of drug clinical trial institu-tions in Liaoning Province after the implementation of the registration system,and to provide data support and targeted sug-gestions for the future development of drug clinical trial institutions in our province.Methods By retrieving information from the official website of the National Medical Products Administration,the National Drug Clinical Trial Institution Regis-tration Management Information Platform,and the Drug Clinical Trial Registration and Information Disclosure Platform,sta-tistical analysis was conducted on the number of registered drug clinical trial institutions in Liaoning Province,regional dis-tribution,level and type,business nature,registered specialties,principal investigators,contracted projects,and drug types.Results Liaoning Province's drug clinical trial institutions have made significant progress after the implementation of the registration system.The total number of institutions has increased to 1.66 times that during the qualification recognition management period.The total number of projects undertaken has increased by 189.73%.However,there are still problems of low national ranking and uneven resource distribution.Discussion It is recommended to promote resource allocation to lower-level areas through policy support and financial assistance,establish standardized training platforms,and encourage cross-regional cooperation to facilitate balanced development of drug clinical trial institutions in Liaoning Province.Mean-while,institutions should also strengthen their self-construction,focus on sponsor needs,and improve their competitive-ness.While pursuing rapid growth,they should also attach importance to quality supervision to jointly promote the standard-ized and scientific development of drug clinical trial institutions in our province.关键词
药物临床试验机构/备案制/辽宁省/临床试验Key words
Drug clinical trial institutions/Liaoning Province/Registration system/Clinical trials分类
医药卫生
