Development And Application Of Generic SAS Macros For ADAS-cog Statistical Analysis Report

Currently, with design of clinical trials becomes more and more complex and diverse, the corresponding Statistical Analysis Plan (SAP) design has become increasingly complex. Therefore, it is more complicated and time-consuming for SAS programmers to write programs for processing data analysis, while a small error may have serious impact on the data analysis during the entire trial. Considering the requirements of work efficiency and quality, it is necessary to implement SAS macro programs to achieve the automation and standardization of clinical trial data processing. In order to meet the special requirements of data processing in clinical trial, SAS macro programs can be designed and compiled to directly generate statistical analysis reports for the primary endpoint in complex disease area. By calling the SAS macro programs without any further processing, people can customize the content of data analysis, standardize its output and generate statistical analysis reports in a way of accuracy, completeness and standardization, thereby greatly improving the efficiency and quality of statistical analysis of clinical data.Although some well-known multinational pharmaceutical companies and Contract Research Organization (CRO) companies have developed SAS macro programs for statistical analysis reports in clinical trial for a long time, which ensure the standardized statistical analysis report of clinical trial, SAS macro programs related to some specific disease areas are still incomplete. Especially in neurological clinical trials, SAS macro programs for the statistical analysis of Alzheimer’s disease remain a research gap. The currently accepted standard for Alzheimer’s disease in clinical trials is the Alzheimer’s Disease Assessment Scale-Cognitive Component (ADAS-cog) which, compared to other primary endpoints, possesses a large amount of data, numerous variables and datasets, and complex data structures. Processing clinical data about Alzheimer’s disease, SAS programmers have to encounter problems of heavy workload, time consuming and error prone.Therefore, based on the ADAS-cog in clinical trial, the present study researched and developed a suite of SAS macro programs through exploration and research work including calculating the ADAS-cog score, handling missing data, post-processing, creating SAS macro dataset, descriptive statistical analysis, inferential statistical analysis, generating statistical tables and figures. Through the powerful Output Delivery System (ODS), the results of statistical analysis output to the datasets. According to domestic and international statistical analysis specifications, statistical table templates are designed to reflect the results of the clinical trials based on the three-line table. In accordance with the contents of these templates, SAS macro programs were compiled to make the statistical analysis results exported into RTF format tables efficiently and accurately.Tested by actual clinical trial data, the SAS macro programs were found to automatically complete the statistical analysis of ADAS-cog, standardize statistical analysis, reduce the workload and improve efficiency in clinical trial. Therefore, our designed SAS macro programs can enormously improve clinical statistics programming efficiency and possesses certain practical application significance.