Current Status of Development of Drug Clinical Trials in Nanjing
Objective To understand the current status of development of drug clinical trials in Nanjing.Methods The relevant information of drug clinical trials registered in Nanjing in 2023 was obtained and summarized from the three websites(https://beian.cfdi.org.cn/CTMDS/apps/pub/drugPublic1.jsp,http://www.chinadrugtrials.org.cn/index.html,http://wjw.nanjing.gov.cn/)to analyze the filing speciality,clinical trial progress and experimental drug.Results There were 28 drug clinical trial institutions,45 specialities,and 985 principlal investigators(PIs)completing filing in Nanjing in 2023,all ranking the first in Jiangsu.The medical institutions were mainly general hospitals(14 institutions,50.00%)and grade-A tertiary hospitals(21 institutions,75.00%).A total of 759 drug clinical trial projects were conducted,mainly in phases Ⅱ and Ⅲ(82.74%).The experimental drugs mainly involved chemical drugs(57.18%)and injections(53.49%),with indications mainly for tumors(30.83%).The main problems in this field in Nanjing included uneven distribution of clinical trial institutions(large differences between the urban areas),insufficient utilization of advantageous resources in drug clinical trials(few times of institutions serving as leaders of international and domestic multi-center trial team),and homogenization of therapy areas(mainly in anti-tumor therapy).Conclusion To promote the development of drug clinical trials in Nanjing,it is suggested that we should improve regional imbalance and allocate resources rationally,establish training system and accelerate talent cultivation,conduct ethical collaboration reviews for multi-center clinical trials to promote mutual recognition of review,build high-level domestic top disciplines,vigorously develop scarce specialities,and encourage the development of clinical trials of traditional Chinese medicine/natural medicines.
drug clinical trialmedical institutionNanjingfiling registrationmulti-center trial
万方数据
维普
