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目的:运用Westgard性能评价图、西格玛指标和QGI指标评价Ⅰ期临床试验的方法学性能,以发现问题,指导质量改进。方法:采用本实验室历年来所建立的具有代表性的方法学数据,计算西格玛值和QGI值,同时绘制Westgard性能评价图,评价各方法学性能,并优化质量控制方案。结果:较为适当的性能评价标准为:性能优秀方法学的三个浓度操作点均应控制在4西格玛以内;性能良好的方法学的三个浓度操作点应控制在3西格玛以内;具有优化余地的方法学的三个浓度操作点应控制在2西格玛以内;三个浓度操作点应控制只要有一点落在2西格玛以外,则应拒绝接受该方法学。结论:采用Westgard性能评价图可以对Ⅰ期试验室所建立的方法学性能进行正确评估,采用西格玛指标和QGI指标,可以明确方法学优化方向。
OBJECTIVE: To evaluate the methodological performance of Phase I clinical trials using Westgard performance evaluation, Sigma and QGI to identify problems and guide quality improvement. METHODS: Based on methodological data developed over the years in our laboratory, we calculated Sigma and QGI values, plotted Westgard performance maps, evaluated methodological performance, and optimized our quality control strategy. Results: The more appropriate performance evaluation criteria are: All three concentration operating points with good performance methodology should be controlled within 4 sigma; Three concentration operating points with good performance methodology should be controlled within 3 sigma; The methodology’s three concentration operating points should be controlled within 2 sigma; three concentration operating points should be controlled as long as there is a point outside 2 sigma, you should refuse to accept the methodology. CONCLUSIONS: The Westgard Performance Map allows a correct assessment of the methodological properties established in Phase I laboratories. Using Sigma and QGI indicators, methodology can be used to optimize direction.