摘要
目的确定研究者发起的临床研究(investigator initiated trial,IIT)项目立项阶段可识别的研究全过程中可能出现的风险因素并评价各因素的风险等级,为制定风险监管计划提供依据。方法通过分析文献及研究小组讨论,初步确定可识别的风险因素及风险等级评价标准,并基于此制定咨询问卷。2021年2—5月,通过德尔菲咨询法进一步优化风险因素类别并评价其风险等级。对咨询获得的数据进行描述性分析。结果2轮专家咨询问卷回收率均为100%,专家权威系数均为0.942。最终确定38项可识别的风险因素,其中极高风险、高风险、中风险、低风险、极低风险的因素分别有17项(44.7%)、15项(39.5%)、3项(7.9%)、2项(5.3%)和1项(2.6%)。结论本研究确定了IIT项目立项阶段的风险评价体系,采用该体系能够及早识别临床研究项目风险,尽早干预项目中存在的问题,最大限度降低患者安全风险。
Objective To assess possible risk factors and their respective levels in the whole process of investigator initiated trial(IIT)projects proposed in the proposal stage,for reference in formulation of risk management plans.Methods Through literature analysis and research group discussions,the risk factors of IIT projects and risk level assessment criteria were preliminarily identified,and a consultation questionnaire was developed as a result.Delphi method was used to further optimize the risk factors and determine their risk levels.Data obtained from the consulfation were analysied by descriptive.Results The recovery rates of two rounds of expert consultation were both 100%,and the degree of expert authority was 0.942.The survey finalized 38 risk factors,including extremely high risk,high risk,medium risk,low risk and very low risk factors of 17(44.7%),15(39.5%),3(7.9%),2(5.3%)and 1(2.6%)respectively.Conclusions This study determined a risk evaluation system of IIT projects in the proposal stage.This system can identify risks of IIT projects at an early stage,facilitating early intervention of problems existing in such projects,and minimize risks to the rights and safety of patients.
作者
吕文文
胡婷婷
张维拓
渠田田
沈恩璐
段加成
孙喆
王戬
钱碧云
Lyu Wenwen;Hu Tingting;Zhang Weituo;Qu Tiantian;Shen Enlu;Duan Jiacheng;Sun Zhe;Wang Jian;Qian Biyun(Clinical Research Center,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;Department of Cardiothoracic Surgery,Xinhua Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200092,China;Discipline Planning Department,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;Shanghai Clinical Research Promotion and Development Center,Shanghai Shenkang Hospital Development Center,Shanghai 200050,China)
出处
《中华医院管理杂志》
CSCD
北大核心
2021年第11期927-931,共5页
Chinese Journal of Hospital Administration
基金
上海交通大学医学院项目(WK2003)。
关键词
科研管理
研究者发起的临床研究
风险评估
立项阶段
Scientific research management
Investigator initiated trial
Risk assessment
Proposal stage
作者简介
通信作者:钱碧云,Email:qianbiyun@sjtu.edu.cn。
