单位：[1]School of Pharmacy, Qingdao University, Qingdao, Shandong, China[2]Phase I Clinical Research Center, The Traditional Chinese Medicine Hospital of Heze, Heze, China[3]Department of Clinical Research, Sun Yat-SenUniversity Cancer Center, Guangzhou, Guangdong, China[4]Department of Pharmacy, Guangzhou First People’s Hospital, Guangzhou, Guangdong, China[5]National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China首都医科大学附属同仁医院[6]Department of Clinical Pharmacology, The Second Hospital of Anhui Medical University, Hefei, Anhui, China[7]Department of Pharmacy, Changzheng Hospital, Second Military Medical University, Shanghai, China[8]GCP Office, Sun Yat-SenMemorial Hospital, Sun Yat-SenUniversity, Guangzhou, Guangdong, China中山大学附属第二医院[9]Clinical Research Unit, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China[10]Clinical Trial Center, China JapanFriendship Hospital, Beijing, China[11]Clinical Research Center, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China[12]Phase I Clinical Research Center, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China[13]Phase I Clinical Research Center, The Shengjing Hospital Affiliated China Medical University, Shenyang, Liaoning, China中国医科大学附属盛京医院[14]Phase I Center of Durg Clinical Trial Institution, The Affiliated Hospital of Bengbu Medical College, Bengbu, China[15]Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
With the improvements in relevant policies, laws, and regulations regarding drug clinical trials in China, the quantity and quality of drug clinical trials have gradually improved, and the development prospects of drug clinical trials for endocrine disorders and metabolism and nutrition disorders are promising. Based on information from the clinical trials from the online drug clinical trial registration platform of the National Medical Products Administration, we aimed to review and evaluate the development of clinical trials of drugs for endocrine disorders and metabolism and nutrition disorders in mainland China from 2010 to 2019, as well as the trends over time. A total of 861 trials were carried out on 254 types of drugs for endocrine disorders and metabolism and nutrition disorders, among which 531 (61.67%) involved endocrine disorders, and 330 (38.33%) addressed metabolism and nutrition disorders. The annual number of clinical trials has been increasing gradually, with a significant increase in 2017. Among them, the proportion of clinical trials with Chinese epidemiological characteristics was relatively large (Wu, Annual Report on Development Health Management and Health Industry in China, 2018). The largest number of trials were for diabetes drugs (55.63%), followed by trials of drugs for hyperlipidemia (19.4%) and those for hyperuricemia (7.9%). It was found that the geographical area of the leading units also showed obvious unevenness according to the analysis of the test unit data. Based on the statistics and evaluation of the data, comprehensive information is provided to support the cooperation of global pharmaceutical R&D companies and research units in China and the development of international multicenter clinical trials in China. This work additionally provides clinical trial units with a self-evaluation of scientific research competitiveness and hospital development strategies. At the same time, it provides a reference with basic data for sponsors and stakeholders in these trials to determine their development strategy goals.
基金：
National Major Scientific and Technological Special Project of china [2017ZX09304024, 2020ZX09101-001, 2020ZX09201002, 2020ZX09201-014, 2020ZX09201-018, 2020ZX09201-021, 2020ZX09201-028, 2020ZX09201-030]; National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81673510]
第一作者单位：[1]School of Pharmacy, Qingdao University, Qingdao, Shandong, China
通讯作者：
通讯机构：[15]Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China[*1]Clinical trials Center, The Affiliated Hospital of Qingdao University. No.16, Jiangsu Road, Qingdao, Shandong, China
推荐引用方式(GB/T 7714)：
Xin Liu,Suqin Wu,Jian Sun,et al.Changes in clinical trials of endocrine disorder and metabolism and nutrition disorder drugs in mainland China over 2010-2019[J].PHARMACOLOGY RESEARCH & PERSPECTIVES.2021,9(2):doi:10.1002/prp2.729.
APA：
Xin Liu,Suqin Wu,Jian Sun,Suiqin Ni,Laichun Lu...&Yu Cao.(2021).Changes in clinical trials of endocrine disorder and metabolism and nutrition disorder drugs in mainland China over 2010-2019.PHARMACOLOGY RESEARCH & PERSPECTIVES,9,(2)
MLA：
Xin Liu,et al."Changes in clinical trials of endocrine disorder and metabolism and nutrition disorder drugs in mainland China over 2010-2019".PHARMACOLOGY RESEARCH & PERSPECTIVES 9..2(2021)
：