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食品和药物管理局公布了题为“E9:临床试验的统计学原理 (StatisticalPrinciples)”的指导性文件 (guidance)。它是在人用药品注册技术要求国际协调会议的赞助下制定的 ,其目的是从统计学的原理和方法出发 ,向申报主办者 (sponsors)和专家提供建议 ,以便有助于为申请 (新药 )入市而作的临床试验的分析与结论得到公认。
The Food and Drug Administration released a guidance entitled “E9: Statistical Principles of Clinical Trials.” It was developed under the auspices of the International Coordination Meeting on Requirements for Registration of Human Drugs with the aim of providing advice to sponsors and experts on the basis of statistical principles and methodologies in order to facilitate the application of new drugs ) Into the market for clinical trials of the analysis and conclusions have been recognized.