Current situation of drug clinical trial institutions in Shaanxi province
Objective To understand the current situation of drug clinical trial institutions in Shaanxi province after the implementation of registration system.Methods Data related to drug clinical trial institutions of Shaanxi province were collected from the Drug Clinical Trial Institutions Registration System and the Drug Clinical Trial Registration and Information Disclosure Platform.We systematically analyzed the institutional development,geographical distribution,speciality for recording,principal investigators,and number and stages of drug clinical trials.Results After the impleentation of registration system,the number of drug clinical trial institutions in Shaanxi province increased to 42,with an increase of 110.0%,and the registration institutions were mainly located in Xi'an,Xianyang,Hanzhong,Baoji,Yan'an and Ankang.The number of recorded specialties increased from 82 to 158,with an increase of 92.68%.The number of registered drug clinical trials increased from 910 to 2173,with an increase of 138.79%.Cinical trial institutions received 66 various inspections,with a first time passing rate of 60.61%.Conclusion After the implementation,drug clinical trial institutions develop well in Shaanxi province,but problems exist such as uneven distribution of resources and professional levels of researchers,shortage of phase Ⅰ clinical research platforms,etc..It is necessary to further integrate clinical research resources,reserve clinical trial professionals,and improve the standardization of clinical trials.