智能化临床试验数据整合与质量控制平台的研发与应用效果评估

Intelligence clinical trial data integration and quality control platform development and evaluation

目的构建智能化临床试验数据整合与质量控制平台(简称iTrial平台),以提升临床试验实施效率及数据质量。方法构建以患者为中心的全生命周期的标准化数据集(PHSR),根据具体试验方案配置以受试者为中心的全生命周期的标准化数据集(SHSR),打造便捷的人机结合模式(HCIM)的iTrial平台。以2个已完成的临床试验(test01和test02)的人工采集数据及其分析结果为对照,验证iTrial平台实现医院内部试验相关数据自动采集并录入电子数据捕获(EDC)系统及试验过程自动化质控的可靠性和优越性。结果PHSR实现了患者全生命周期院内全量临床数据实时汇总,在此基础上构建的SHSR可提供的时间和数据维度远大于传统受试者原始病历临床数据库;根据2个临床试验真实案例配置的SHSR比较结果显示,基于iTrial平台的HCIM模式提升了临床试验数据录入效率和质量,在监查或稽查数据的时效性上优于人工监查模式,同时可以实现基于风险的稽查和全量数据稽查。结论依托患者PHSR配置SHSR,构建HCIM的iTrial平台,在采集和上报临床试验数据和辅助完成监查或稽查方面优势明显,可提升临床试验质量和效率。

AIM To construct an intelligent data integration and data quality control platform for clinical trials of new drugs,referred to as iTrial to improve the conduction efficiency and the data quality of clinical trials comprehensively.METHODS A whole patient lifecycle standardized data set(personal health standardized record,PHSR)was construct,and the subject health standardized record(SHSR)was build according to the specific protocol based on PHSR.A convenient human-machine combination interaction model(HCIM)was created to reality the iTrial platform finally.The results of two completed real clinical trials(test01 and test02)were selected to compare the locked data in electronic data capture(EDC)system between the manual data collection method and the iTrial automatic data collection method,and to verify the reliability and superiority of the automatic data collection method and quality control of the clinical trial by iTrial platform.RESULTS PHSR provided the real-time data acquisition of the patient whole lifecycle clinical data within hospital.SHSR provided wider time range and more research variables than the traditional source data of the subjects.In accordance with the protocols,two SHSRs verified the HCIM model of iTrial platform could improve the efficiency and quality of clinical trial data collection.The HCIM model of iTrial could upgrade the timelines in auditing and monitoring of clinical trial,moreover iTrial could support risk-based and full data trial auditing.CONCLUSION Establishing iTrial platform based on SHSR that relying on the patient PHSR combining with the HCIM model has obvious advantages in collecting and reporting clinical trial data and assisting in completing the monitoring and auditing,which can improve the quality and efficiency of clinical trials.