摘要
本文以我国现行法律法规框架为基准,结合实际案例,系统、全面地分析肿瘤新生抗原疫苗的监管属性、临床试验监管模式及存在的问题,旨在为我国肿瘤新生抗原疫苗临床试验监管体系的构建提供参考。结果发现,目前我国对肿瘤新生抗原疫苗的临床试验采用双轨制监管模式:制药企业发起的临床试验和研究者发起的临床试验监管模式。该模式滞后于行业发展速度,主要表现在:双轨制监管带来的挑战;研究者发起的临床试验数据用于新药研究申请缺乏有效衔接;临床试验监管指导原则有待完善。相关医疗机构、监管部门、协作企业等可从上述方面协同助力我国肿瘤新生抗原疫苗临床试验监管体系发展。
Based on the current laws and regulations framework of China,combined with practical cases,this paper systematically and comprehensively analyzes the supervision attributes,clinical trial supervision model and existing problems of tumor neoantigen vaccine,aiming to provide reference for the construction of the supervision system of clinical trial of tumor neoantigen vaccine in China.The results showed that,at present,the clinical trials of tumor neoantigen vaccine in China adopt a dual-track supervision model:clinical trials initiated by pharmaceutical enterprises and clinical trials initiated by researchers.This supervision model lags behind the development speed of the industry,mainly in the following aspects:challenges brought by dualtrack supervision;the clinical trial data initiated by researchers are not effectively connected with new drug research applications;the guiding principles of clinical trial supervision need to be improved.Relevant medical institutions,regulatory authorities and cooperative enterprises can help the development of the regulatory system for clinical trials of tumor neoantigen vaccine in China from the above aspects.
作者
刘强
卢梦情
胡洪果
陈亮江
姚文兵
LIU Qiang;LU Mengqing;HU Hongguo;CHEN Liangjiang;YAO Wenbing(School of International Pharmaceutical Business/Key Laboratory for Drug Supervision Innovation and Evaluation of National Medical Products Administration,China Pharmaceutical University,Nanjing 211198,China;Shenzhen Health Development Research and Data Management Center,Guangdong Shenzhen 518000,China;Chongqing Yaopharma Co.,Ltd.,Chongqing 401121,China)
出处
《中国药房》
CAS
北大核心
2022年第23期2826-2830,共5页
China Pharmacy
基金
中国药科大学药品监管科学研究院2021年研究课题。
关键词
肿瘤新生抗原疫苗
临床试验
监管模式
监管现状
tumor neoantigen vaccine
clinical trial
supervision model
current status of supervision
