Study Of Regulation Of Statisitial Analysis In The Clinical Trials And Completed By SAS Software

As an important part of clinical trial, statistical analysis plays an important role in the whole clinical trial. Standardized statistical analysis is not only the foundation for evaluation of security and validity of drug, but also the important sign of standardized high-quality clinical trial. In order to improve the internal statistical analysis of clinical trial and connect with international GCP criterion and advanced statistical analysis criterion of clinical trial as soon as possible, this study was done to obtain high-quality statistical analysis outcome precisely, quickly and safely.Object: studying how to hold and exert standardized statistical analysis criterion of clinical trial in practice, and make it to be feasible method. At the same time discussing the problems of ensuring the scientificity, integrality and security of statistical analysis report of clinical trial.Method: realizing the development and status quo of statistical analysis of clinical trial standardized management at present through reviewing literature;studying the connotation of standardized statistical analysis of clinical trial worldwide, ensuring the operation method followed the guideline according to the situation of our country and the clinical practice habit;studying the statistical analysis method by statistical analysis software SAS, extracting key statistic of statistical analysis by compiling SAS program;defining the model of three-line table, outputting extracted statistic into PDF format document by ODS function, and accomplishing the statistical tables in the statistical analysis report.Conclusion: through literature reviewing and document consulting, the development of standardized clinical trial management are divided into three phases, 1) forming phase of clinical trial and management system;2) forming phase of standardized and legalized clinical trial management;3) forming phase of international standard of clinical trial management criterion. The guidelines of standardized statistical analysis of clinical trial, which were made severally by managements both internal and international, were quite similar in both request and content, and can be divided into several parts as follows, 1) establishing of statistical plan;2) ensuring of analysis data set;3) handling of missing data and outlier;4) datatransformation;5) ensuring of statistical method. Statistical analysis report which is established followed the request includes: 1) distribution of subject;2) analysis of comparable baseline;3) analysis of effectiveness index;4) safety analysis;5) analysis of combination drug. As SAS has powerful function and our school is the legal user, so SAS is selected to perform statistical analysis, the SAS macro programs compiled to extract statistic relate to MEANS, UNIVARIATE, FREQ, NPAR1WAY, GLM/ANOVA several SAS procedures. Three-line table model is defined by TEMPLATE SAS procedure and statistical tables in the statistical analysis report are outputted to PDF format document by ODS function.Discussion: the problems of software edition and clearing of database should be cared to make statistical tables by SAS software. A lot of temporary data sets are made by the macro programs in the study. When the macro programs run again, the temporary data sets which already existed should be cleared to ensure that the temporary data sets made later will not be mixed up with those which already existed;the survey is done by SAS9.1.3, the macro programs should be modified when applied in other editions. In addition, there are still some details not meet the need of statistics, such as the problem of arranging several statistical tables on one page and the problems of inapposite position of captions and remarks, which need the help of SAS developer to solve.