临床研究伦理审查的实例研究与对策思考  

Empirical study and discussion on supervision of ethical review in clinical research

作　　者：陈洁茹 安婼娜 李明玥 陆麒[1] 杨海燕 茅益民 戴慧莉[4] 周争[4] CHEN Jie-ru;AN Ruo-na;LI Ming-yue;LU Qi;YANG Hai-yan;MAO Yi-min;DAI Hui-li;ZHOU Zheng(Ethics Committee Ofice,Renji Hospital,Shanghai Jiaotong University School of Medicine,SHANGHAI 200001,China;National Drug Clinical Trial Institutions Office,Renji Hospital,Shanghai Jiaotong University School of Medicine,SHANGHAI 200001,China;Department of Gastroenterology,Renji Hospital,Shanghai Jiaotong University School of Medicine,SHANGHAI 200001,China;Science Research Office,Renji Hospital,Shanghai Jiaotong University School of Medicine,SHANGHAI 200001,China)

机构地区：[1]上海交通大学医学院附属仁济医院伦理委员会办公室,上海200001 [2]上海交通大学医学院附属仁济医院国家药物临床试验机构办公室,上海200001 [3]上海交通大学医学院附属仁济医院消化科,上海200001 [4]上海交通大学医学院附属仁济医院科研处,上海200001

出　　处：《中国新药与临床杂志》2023年第7期439-443,共5页Chinese Journal of New Drugs and Clinical Remedies

基　　金：上海申康医院发展中心促进市级医院临床技能与临床创新能力三年行动计划(20CR40010C)。

摘　　要：目的 通过分析医院临床研究项目及伦理审查情况,为提升临床研究伦理审查能力提供有益参考。方法 以本院2012—2021年期间经伦理审查的以注册为目的由制药企业发起的临床研究(IST)和研究者发起的临床研究(IIT)项目为实例,综合比较与分析IST和IIT的发展趋势、特点以及伦理审查情况。结果 2012—2021年本院IIT项目所占比重和数量呈现整体增长趋势。相较于IST,IIT的国际多中心及国内组长单位项数少、主要研究者职称参差不齐、高风险临床研究项数多,且IIT在初始审查通过率、按要求跟踪审查等方面尚存有差距。结论针对当前IIT的增长趋势、特点及伦理审查存在的不足,应加强医院伦理委员会建设、完善伦理跟踪审查程序、建立伦理审查前风险评估机制和动态跟进伦理培训,以提升临床研究伦理审查能力及规范过程管理。AIM To analyze the clinical research projects and ethical review situation,useful references are provided to enhance the ethical review ability of clinical research.METHODS Taking the industry sponsored trial(IST)and investigator initiated trial(1IT)as the research subjects,which were ethically reviewed in our hospital from 2012 to 2021,the development trend,characteristics and ethical review situation of IST and IT were comprehensively compared and analyzed.RESULTS The proportion and quantity of IT show an overall growth trend in our hospital from 2012 to 2021.Compared with IST,IIT still has gaps in the number of international multi-centered clinical trials and primary sponsors,the proportion of the title of the principal investigator,high-risk clinical studies,the passing rate of initial ethical review,and the continuous review.CONCLUSION Regarding the current growth trend,characteristic and shortcomings in ethical review of IT,it is necessary to strengthen the construction of hospital ethical review management system,improve the standard operation process of ethical review,improve ethical tracking and review procedures,establishing a risk assessment mechanism before ethical review and dynamically follow up ethical training to standardize the ethical review and process management of clinical research and promote the high-quality development of clinical research.

关 键 词：伦理学委员会 临床 临床研究 研究人员 

分 类 号：R95[医药卫生—药学]