基于风险的移动医疗APP在药物临床试验数据采集的应用  

Discussion of risks of application of mobile medical applications in data capture during drug clinical trials

作　　者：汶柯[1] 王瑾[1] 蔡芸[1] 白楠[1] 王睿[1] 

机构地区：[1]解放军总医院药物临床研究中心,北京100853

出　　处：《中国新药杂志》2017年第22期2706-2709,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项资助项目(2012ZX09303004-002)

摘　　要：临床试验的数据质量和真实完整性是对试验药物的有效性和安全性进行正确评价的基础。我国尚未对医疗APP可否应用于药物临床试验数据采集做相关规定。通过识别和评估医疗APP应用于临床试验数据采集潜在风险,了解其在受试者信息、有效性及安全性、数据采集质量方面均具有高风险性。因此,亟需有关部门出台相关政策或技术指南,解决医疗APP应用于临床试验数据采集的合规性框架界定、基于风险的分级监管、采集数据范围的界定等问题。伦理委员会和研究机构也需要在试验开展之前对医疗APP应用于试验数据采集的风险是否将出现高于最小风险进行评估判断。The authenticity and completeness of drug clinical trial data are the basis for correct evaluation of the effectiveness and safety of investigational products. There have no relevant provisions in China yet on whether mobile medical applications can be applied in data collection of drug clinical trials. It was learned through identification and assessment of the risks of mobile medical applications that there is potential high risk in terms of subjects＇ information security,effectiveness and safety and the quality of data capture. Therefore,relevant policies or technical guidelines are needed to solve the problems faced by mobile medical applications during data capture,including the definition of compliance,risk-based hierarchical supervision and the scope of data collection. Ethical committees and research institutions also need to evaluate whether the risks will be higher than the minimum risk when mobile medical applications are being applied before the trial is conducted.

关 键 词：临床试验 风险管理 医疗APP 数据采集 

分 类 号：R969.4[医药卫生—药理学]