我国抗肿瘤药物临床试验研究热点

Research Hotspots of Clinical Trials of Anti-Tumor Drugs in China

目的 总述我国抗肿瘤药物临床试验研究热点。方法 提取药物临床试验登记与信息公示平台2013年至2020年登记的我国(该平台未收录香港地区、澳门地区、台湾地区相关信息)除生物等效性试验外的抗肿瘤药物临床试验信息,包括药物类型、临床试验分期、药物靶点、申办者、机构等。采用Gephi 0.9. 2软件生成社会网络合作图。结果 共纳入2 143项抗肿瘤药物临床试验,其中2014年和2015年的数量较少(97项、104项),从2016年起逐年增加(从211项增至477项);其中,药物类型以化学药物的临床试验最多(1 238项),以试验分期Ⅰ期药物临床试验数量最多(951项)。共涉及药物靶点99种(除未披露的外),药物临床试验数量排前3的药物靶点为程序性死亡受体-1/程序性死亡配体-1(PD-1/PD-L1,281项,13.11%),表皮生长因子受体(128项,5.97%),人表皮生长因子受体2(79项,3.69%);临床试验适应证主要集中于实体瘤(389项)、肺癌(382项)、乳腺癌(239项)、淋巴瘤(229项)、肝癌(148项)。共722个申办者与617个药物临床试验机构建立合作关系;开展抗肿瘤药物临床试验较多的申办者分别为江苏恒瑞医药股份有限公司、上海恒瑞医药有限公司、正大天晴药业集团股份有限公司,机构分别为北京大学肿瘤医院、河南省肿瘤医院、哈尔滨医科大学附属肿瘤医院。结论 PD-1/PD-L1是肿瘤靶向治疗领域最热门的药物靶点。开展抗肿瘤药物临床试验应密切关注我国有关新药研发和注册的政策法规和指导原则,并关注具有临床价值的肿瘤创新药或改良型新药的研发。

Objective To summarize the research hotspots of clinical trials of anti-tumor drugs in China.Methods The information on the clinical trials of anti-tumor drugs excluding bioequivalence tests registered on the Drug Clinical Trial Registration and Information Disclosure Platform in China(not including relevant information of Hong Kong region,Macao region and Taiwan region)from 2013 to 2020 was extracted,including drug type,clinical trial phases,drug targets,sponsors,institutions,etc.The Gephi 0.9.2 software was used to generate social network cooperative diagrams.Results A total of 2143 clinical trials of anti-tumor drugs were included.There were fewer clinical trials in 2014 and 2015(97 ones,104 ones),while those increased year by year since 2016,from 211 to 477 ones.Among them,the majority were focused on chemical drugs(1238 ones),and the phaseⅠclinical trials were the most(951 ones).There were 99 drug targets involved(excluding undisclosed ones),and the top three involving more drug clinical trials were the programmed death-1/programmed death-ligand 1(PD-1/PD-L1,281 ones,13.11%),epidermal growth factor receptor(128 ones,5.97%)and human epidermal growth factor receptor 2(79 ones,3.69%).The indications for clinical trials were mainly solid tumors(389 ones),lung cancer(382 ones),breast cancer(239 ones),lymphoma(229 ones),and liver cancer(148 ones).A total of 722 sponsors established cooperative relationships with 617 drug clinical trial institutions.The sponsors conducted more clinical trials of anti-tumor drugs were the Jiangsu Hengrui Pharmaceutical Co.,Ltd.,Shanghai Hengrui Pharmaceutical Co.,Ltd.and Chiatai Tianqing Pharmaceutical Group Co.,Ltd.,and the institutions conducted more clinical trials were the Peking University Cancer Hospital,Henan Cancer Hospital,Cancer Hospital Affiliated to Harbin Medical University.Conclusion PD-1/PD-L1 is the most popular drug target in the field of targeted therapy for tumors.When conducting clinical trials of anti-tumor drugs,it is important to closely follow the policies,regulations,and guiding principles related to research and development(R&D)and registration of new drugs in China,and pay attention to the R&D of innovative or improved cancer drugs with clinical value.