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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 data quality and true integrity of clinical trials are the basis for a correct assessment of the efficacy and safety of the test drugs. China has not yet applied medical APP on drug clinical trial data collection to do the relevant provisions. By identifying and assessing the potential risks of using medical APP in clinical trial data collection, it is known that there is a high risk of the information, validity and safety of the participants and the quality of data collection. Therefore, the relevant departments are urgently required to issue relevant policies or technical guidelines to solve the problems of medical APP application in the definition of compliance framework for clinical trial data collection, risk-based hierarchical regulation and the definition of data collection scope. Ethics committees and research institutes also need to assess whether the risk of applying medical APPs to test data acquisition will be higher than the minimum risk prior to testing.