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我国抗肿瘤药物临床试验研究热点

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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、澳门、台湾相关信息)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。
Research Hotspots of Clinical Trials of Anti-Tumor Drugs in China
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,Macau and Taiwan)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 2 143 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(1 238 ones),and the phase Ⅰ clinical 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.

anti-tumor drugclinical trial of drugtarget of drugsocial network analysisresearch and development of new drug

戴炜均、张震坡、宿凌、王宇婷、马麟

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南方医科大学第七附属医院,广东 佛山 528244

暨南大学药学院,广东 广州 511443

广州中医药大学第二附属医院,广东 广州 510120

抗肿瘤药物 药物临床试验 药物靶点 社会网络分析 新药研发

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(14)
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