医疗器械临床试验方案偏离的全周期质量控制研究

Research on medical devices clinical trial protocol deviation from full-cycle quality control

目的:对医疗器械临床试验方案偏离进行全周期质量控制,确保医疗器械临床试验的安全性和有效性。方法:分别纳入医院2019年16项医疗器械临床试验项目的202例研究病历和2020年14项医疗器械临床试验项目的196例研究病历,分析医疗器械临床试验方案偏离的分类与分级以及方案偏离的报告和流程,针对研究者因素、受试者因素和运营团队因素导致的偏离,制定医疗器械临床试验方案偏离全周期质量控制纠正和预防偏离措施。结果:2019年16项医疗器械临床试验项目的202例研究病历中,发生医疗器械临床试验方案偏离52例(轻微方案偏离43例,严重方案偏离9例),占25.7%;通过方案偏离的全周期质量控制后,2020年14项医疗器械临床试验项目196例研究病历中,发生医疗器械临床试验方案偏离13例(轻微方案偏离11例,严重方案偏离2例),占6.6%,较2019年显著下降。结论:医疗器械临床试验方案偏离全周期质量控制可以全面改善与完善医疗器械临床试验质量控制与评估,规范临床试验行为,确保临床试验各项数据真实有效。

Objective:To study the of protocol deviation of clinical trials of medical apparatus and instrument from the full-cycle quality control,to ensure the safety and effectiveness of clinical trials of medical apparatus and instrument.Methods:202 researched medical records of 16 clinical trial items of medical apparatus and instruments in 2019 and 196 researched medical records of 14 items of medical apparatus and instruments in 2020 were respectively included.The classification and grading of protocol deviation of clinical trials of medical apparatus and instrument,and report and process of protocol deviation were analyzed.Aimed at the deviations from researcher factor,subjects factor and operation team factor,the correction of full-cycle quality control of clinical trial protocol of medical apparatus and instrument and the measurement of preventing deviation were formulated.Results:In 202 researched medical records of 16 clinical trial items of medical apparatus and instrument in 2019,52 cases occurred deviations in clinical trials of medical apparatus and instrument(43 cases were mild deviation and 9 cases were severe deviation),which percentage was 25.7%.After the full-cycle quality control of protocol deviation was implemented,13 cases occurred deviations in clinical trials of medical apparatus and instrument(11 cases were mild deviation and 2 cases were severe deviation),which percentage was 6.6%that was significantly decreased than 2019,in 196 researched medical records of 14 clinical trial items of medical apparatus and instrument in 2019.Conclusion:The full-cycle quality control of the deviation of clinical trial protocol of medical apparatus and instrument can comprehensively improve and perfect the quality control and the assessment of clinical trials of medical apparatus and instrument,and regulate the conduct of clinical trial,and ensure the authenticity and effectiveness of each data of clinical trial.