重庆市新型冠状病毒肺炎疫情期间临床试验开展现状调查

Investigation on the Current Situation of Clinical Trial During COVID-19 Epidemic in Chongqing

目的为完善药物临床试验机构(以下简称机构)质量管理体系建设提供参考。方法采用横断面研究设计,以半结构访谈法制订重大疫情暴发期间临床试验项目的现状调查问卷表;通过问卷星软件制作问卷,于2021年1月15日至1月31日在重庆市范围内采用方便抽样联合滚雪球抽样的混合抽样方式进行调查,通过微信、QQ、电子邮件等方式向调查对象发放电子问卷二维码。分析重庆市新型冠状病毒肺炎疫情暴发期间和复工期间临床试验项目开展情况,并分析相关影响因素。结果回收282份有效问卷,有效回收率为100.00%,其中89.01%(251/282)的调查对象具有参与临床试验项目的经验。与复工期间比较,疫情暴发期间的项目立项(χ^(2)=237.37,P<0.001)、伦理审查的速度(χ^(2)=211.53,P<0.001)、项目合同签署(χ^(2)=129.38,P<0.001)、人遗传办申报(χ^(2)=125.95,P<0.001)、新项目启动(χ^(2)=276.37,P<0.001)、项目质量(χ^(2)=159.53,P<0.001)均受到较大影响。新项目立项受阻的原因主要为机构建议暂缓或不接待,严重不良事件或方案违背不能及时上报的原因主要为研究医师无法及时获知受试者信息,项目质量受影响的原因主要为访视计划被打乱。结论各机构应梳理与总结疫情期间各方面的处置措施,引入信息化手段保障质量,推进临床试验信息共享,降低突发公共卫生事件对临床试验的影响。

Objective To provide a reference for improving the construction of quality management system of drug clinical trial institutions(hereinafter referred to as institutions).Methods The cross-sectional study was used to formulate questionnaires on the current situation of clinical trials during the outbreak of major epidemic by the semi-structured interviews.Questionnaire Star software was used to the make questionnaires.The mixed sampling method of convenient sampling and snowball sampling was used to conduct the investigation in Chongqing from January 15 to January 31,2021.The quick response(QR)code of the electronic questionnaire was distributed to the respondents by the ways such as WeChat,QQ and e-mail.The implementation of clinical trials during the outbreak of coronavirus disease 2019(COVID-19)epidemic and resumption of work in Chongqing was investigated to analyze the relevant influencing factors.Results A total of 282 valid questionnaires were recovered with an effective recovery rate of 100.00%.Precisely 89.01%(251/282)of the respondents had the experience in participating in clinical trial projects.Compared with those during the period of resumption of work,the project setup(χ^(2)=237.37,P<0.001),speed of ethical review(χ^(2)=211.53,P<0.001),contract signing of project(χ^(2)=129.38,P<0.001),application of human genetics office(χ^(2)=125.95,P<0.001),new project initiation(χ^(2)=276.37,P<0.001)and quality of projects(χ^(2)=159.53,P<0.001)during the outbreak of epidemic were all greatly effected.The main reason for the obstruction of new project setup was the delay or non-reception of organizations.The main reason for the delayed reporting of serious adverse events or protocol violations was that the research physicians could not obtain the information of the subjects in time.The main reason why the quality of the project was affected was that the visit plan was disrupted.Conclusion All institutions should summarize the disposal measures during the epidemic and introduce information technology to ensure the quality,promote the sharing of clinical trial information and reduce the effect of public health emergencies on clinical trials.