Programing And Application Of SAS Programs For Tables Of Statistical Analysis Reports In Clinical Trials Of Hemodialyzers

Objective: This study aimed at developing a set of SAS macro programs for the automatic output of statistical reports of the clinical trials of hemodialyzers,so that they can finish the statistical analysis tasks of this type of clinical trials efficiently,accurately and standardizedly.This study hoped to further improve the level of generating tables for statistical analysis reports in clinical trials of hemodialysis medical devices and even all drugs and medical devices.Methods: 1)The clinical trial of hemodialyzer was the research object.According to the common analysis indexes of this type of clinical trial,and combining the domestic relevant guiding principles to the requirements of the statistical analysis reports of clinical trials,this study used the SAS statistical analysis software as a research tool to develop a series of appropriate SAS analysis macro programs to generate statistical analysis report,the steps are as follows:(1)Introducing the data set to analyze through SAS software according to the different parts of the statistical analysis report;(2)Using the data step and process step of the SAS software to select the appropriate statistical analysis methods for the variables of different data types,the processes included MEANS,FREQ,UNIVARIATE,GLM,ANOVA,NPAR1 WAY and so on;(3)Taking advantage of the ODS function to capture the statistical description and statistics of these analysis processes,and then collect and collate the data set to facilitate the generation of the corresponding statistical tables in the subsequent steps;(4)The processes above were created as macro programs,and the compiled statistical results are generated into tables through the REPORT process,and output through the ODS function to RTF.2)To apply these macro programs to generate the tables for statistical analysis report of a high-flux hemodialyzer clinical trial to verify the operation effect of these macros.Result: 1)This study developed a set of SAS macro programs which can be used to analyze the clinical trials of hemodialyzer based on the requirements of the latest relevant guidelines of statistical analysis for clinical trials.The macros programs included the analysis of the baseline data,the analysis of the primary endpoint,the non-inferiority test of the primary endpoint,the analysis of the secondary endpoint,and the analysis and description of the adverse events and so on.The programs had the characteristics of easy to understand and strong universality.2)The macro programs were applied to the statistical analysis for the clinical trial data of a high-flux hemodialyzer,combined with the REPORT process and the output delivery system(ODS)of SAS to output the table to RTF.The result shows that the program runs well,and the it can autoly output tables for statistical analysis in a very short time,the tables can meet the requirements of statistical principles and relevant guiding principles.Conclusion: The SAS macro programs written in this study can be applied to the production of tables for statistical analysis reports in clinical trials of hemodialyzer.The output results of these programs can replace most of manual tabulation.The programs can not only ensure the accuracy of the data,but also save a large amount of time.This set of SAS macro programs had strong extensibility and can be applied to generate tables for statistical analysis reports in other types of clinical trials.Therefore,this study embodied the strong application value.