我国妇产科注册药物临床试验开展现状分析与启示

目的:分析我国妇产科申请注册上市的药物临床试验开展情况,为我国妇产科药物研发提供参考.方法:通过收集国家药品监督管理局药品审评中心药物临床试验登记与信息公示平台中以女性为受试者对象的药物公示信息,对其试验类型、药物类型、试验分期、试验状态、申办方等信息进行归纳分析.结果:截至2021年7月15日,平台共登记13 866...

Situation analysis and enlightenment of the clinical trials on registered drugs used in gynaecology and obstetrics in China

OBJECTIVE To analyze the current status of the registered gynaecology and obstetrics drug clinical trials in China for the purpose of providing reference for the improvement.METHODS Information about gynaecology and obstetrics drug clinical trials in women was collected from the clinical trials explicitly labeled of CDE. The clinical trial type, drug classification, clinical trial stage, current trial status and sponsor’s information, etc were analyzed statistically.RESULTS By 15 July, 2021, 13 866 clinical trials had been registered on the platform, including 585 drug clinical trials in women. Among the gynecology and obstetrics drug clinical trials, phase Ⅲ clinical trials had the largest number. In aspect of drug classes, chemical drugs had the largest number of clinical trials, followed by biological products, while traditional Chinese medicine had the least registration number. There was the most number of drug clinical trials in the field of gynecological tumor treatment, followed by reproductive endocrine system drugs, which were 265 and 116, respectively. There were only 55 international multicenter clinical trials.CONCLUSION The number of gynaecology and obstetrics drug trials in China is increasing steadily and the proportion of biological products is rising. More and more attention has been paid to the research of gynecological tumor drugs. Despite domestic pharmaceutical companies have become an important force in clinical trials of obstetrics and gynecology, the proportion of international multicenter trials is still low.