国内外抗菌药物临床试验统计学要求比较

目的：针对国内目前抗菌药临床试验统计学要求中存在的一些问题进行探讨，对规范抗菌药临床试验起到一定的参考作用。方法：收集国内外抗菌药物临床试验统计学要求的有关法规和文献，针对统计分析人群和统计分析方法等方面国内外要求的异同点加以比较。结果：国内外在抗菌药临床试验的统计分析人群的定义有所不同；在所采用的统计分析方法和样本量估算方面的要求类似。结论：我国目前对抗菌药所采用的有效性分析人群在应用方面和国外存在不同，建议调整临床有效性评价标准以适合研究需要，并在许可条件下进一步对有病原菌证据的人群进行分析。

Comparison of statistical considerations in clinical trials of antibacterial agents

Objective:To provide a rationale for the statistical considerations in clinical trials of antibacterial agents.Methods: A retrospective comparison of domestic versus foreign approaches to statistical population and statistical methodology was conducted based on the guidelines and literatures of statistics in clinical trials of antibacterial agents.Results: The definitions of statistical population used in the domestic and foreign clinical trials of antibacterial agents were diverse,but the approaches to statistical methodology and sample size calculation were similar.Conclusion: The differences of domestic approaches to effective analysis of population standard from the abroad were evident.An adjustment of evaluation criteria on clinical efficacy was recommended.A further analysis on the pathogenic vectors is necessary as permitted.