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统计分析人群划分是数据库锁定前的一项重要数据管理工作,也是影响试验假设是否成立的关键环节。盲态下统计分析人群划分的客观性是对试验结果科学性的保证。所有随机化后接受过试验治疗的受试者均应进入安全性数据集,全分析集应尽可能接近符合意向性分析原则的理想的受试者集,符合方案集的划分是盲态审核中主观性较强、最难以把握的环节。客观的划分统计分析人群涉及到数据的准确性、核查的全面性以及讨论的科学性,无一不是对数据管理的严格要求。确保统计分析人群划分的客观性、科学性既是提高数据管理质量的重要途径,也是主要目的之一。
Statistical analysis of the population is an important data management before the database is locked, but also affect the test hypothesis is established key link. Objectivity of population division in statistical analysis under the condition of blindness is the guarantee of the scientific result of the experiment. All randomized subjects who received the test treatment should enter the safety data set, the full analysis set should be as close as possible to the ideal set of subjects in line with the principle of intent analysis, the plan is divided into blind review Subjectivity, the most difficult to grasp the link. The objective division of statistical analysis of the population involved in the accuracy of the data, the verification of the comprehensive and scientific discussion, are all the strict requirements of data management. Ensuring the objectivity and scientificness of the population in statistical analysis is not only an important way to improve the quality of data management, but also one of the main purposes.