摘要目的 探讨中美国诊断试剂临床试验指导原则.方法 比较美国FDA和中国SFDA发行的诊断试剂试验的指导原则,并通过具体事例分析两国的诊断试剂试验指导原则之异同.结果 对比而言,SFDA给出的指导原则相对笼统;FDA给出的指导原则较为详细,但也有一定缺陷.结论 应增加定量测量结果一致性评价的统计指导.

abstractsObjective To discuss the two versions of Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests published by SFDA and by FDA. Methods From this article, the Statistical Guidance published by administrations from the two countries were compared and analyzed over the similarities and differences between them through concrete examples. Results Guidance published by SFDA is not detailed enough. Guidance published by FDA is more detailed compared to its SFDA counterpart, despite of its own insufficiency. Conclusion Practicability and agreement of the quantitative result should be involved in the Statistical Guidance.