基于科学监管体系的中国药物临床试验实施质量国际评估比较

International comparison and assessment of the quality of drug clinical trial implementation in China based on scientific regulatory system

目的分析中国临床试验实施的质量,探讨中国临床研究质量科学监管的优势和价值。方法收集2023年7月21日前来源于国家药品监督管理局公开发布的相关报告、国家药品监督管理局食品药品审核查验中心发布的核查报告及公告、美国食品药品监督管理局官方网站显示的核查数据、美国国立综合癌症网络和中国临床肿瘤学会发布的临床诊疗指南中关于临床试验以及相关药物的数据,对中国药物临床试验实施的监管现状、核查数据以及肿瘤新药批准上市情况和实践应用反馈进行分析。结果中美临床试验质量检查体系主线基本一致,其检查对象、关注重点、公开路径基本相同,但其在检查对象、类型等方面有自身特点。我国临床试验数据质量不断提升,2009—2015年和2016—2023年接受美国食品药品监督管理局生物研究试验监查体系检查分别为25次和20次,检查结果为不需要采取措施由48.0%(12/25)提高至85.0%(17/20)、自愿采取行政措施由44.0%(11/25)下降至15.0%(3/20),需要采取官方行政措施分别出现在2009年和2012年,相对于2009—2015年,2016年之后临床试验数据核查结果提升趋势明显。2016—2023年获批上市的中国药企开发的抗肿瘤新药被纳入专业指南的次数持续增加,被纳入2022版中国临床肿瘤学会指南和2023版美国国立综合癌症网络指南推荐应用的新药分别有37种(58.7%)和15种(23.8%),其中有10种新药被2种指南同时纳入。结论中国临床试验实施质量已具备一定国际认可度和竞争力,这得益于国家宏观引导、特色机构模式及与国际接轨的临床实践。未来需进一步加强科学监管体系和临床研究能力建设,以持续推进临床试验高质量发展。

ObjectiveTo analyze the international status and level of clinical trial quality in China,and explore the advantages and value of scientific regulation of clinical research quality in China.MethodsThe data is sourced from the relevant reports publicly released by the National Medical Products Administration(NMPA),the inspection reports and announcements published by the Center for Food and Drug Inspection of the NMPA,the inspection data displayed on the official website of the U.S.Food and Drug Administration(FDA),as well as clinical diagnosis and treatment guidelines issued by the National Comprehensive Cancer Network(NCCN)of United States and the Chinese Society of Clinical Oncology(CSCO)(data as of July 21,2023).This data provides an analysis of the regulatory status of the implementation of clinical drug trials in China,inspection data,and the approval and market entry of new oncology drugs and feedback from their practical application.ResultsThe clinical trial quality inspection systems of China and the United States are generally aligned,with similar inspection subjects,focus areas,and public disclosure pathways.However,each has its characteristics in terms of inspection targets and types.The quality of clinical trial data in China has been continuously improving.Between 2009-2015 and 2016-July 2023,China underwent 25 and 20 FDA Bioresearch Monitoring(BIMO)inspections,respectively.The inspection results showing"No Action Indicated"(NAI)improved from 48.0%to 85.0%,while"Voluntary Action Indicated"(VAI)decreased from 44.0%to 15.0%.Official Action Indicated(OAI)measures were required in 2009 and 2012.Compared to the 2009-2015 period,there has been a clear upward trend in the quality of clinical trial data since 2016.From 2016 to July 2023,the number of new oncology drugs developed by Chinese pharmaceutical companies and included in professional guidelines has steadily increased.Specifically,37 drugs(58.7%)were included in the 2022 edition of the CSCO guidelines,and 15 drugs(23.8%)were included in the 2023 edition of the NCCN guidelines,with 10 of these drugs featured in both guidelines.ConclusionsThe implementation quality of clinical trials in China has gained a certain level of international recognition and competitiveness.This progress is attributed to national macro-level guidance,a unique institutional model,and clinical practices aligned with international standards.In the future,it will be necessary to further strengthen the scientific regulatory system and enhance clinical research capabilities to continue advancing the high-quality development of clinical trials.