| Drug clinical trial is an extremely critical stage throughout the whole drug research and development process, and the entire process of clinical trials must be in strict compliance with laws and regulations of relevant international organizations such as ICH and WHO and countries. The statistical analysis of clinical trials throughout the entire clinical trial process, so the quality of the statistical analysis in certain extent determines the success or failure of the entire clinical trial, and its importance is evident. As a common form of expression for statistical analysis and clinical trial reports, statistical graphic, with the characteristics of its own intuitive, image and huge information covering plays a unique and important role in the statistical analysis, the creation of statistical graphics is also an integral part of the process of statistical analysis in clinical trials.SAS software with its powerful and comprehensive statistical analysis capabilities is recognized by the drug approval agencies around the world, such as the U.S. FDA and other departments, and become the world’s major pharmaceutical companies and pharmaceutical research institutions preferred statistical software. However, the main using way of SAS software is complex coding process, which compared with the menu-driven operation of some statistical software is more complicated. Especially in statistical graphics rendering process, a lot of coding and variety of choice entry set make the clinical-statistical become time-consuming.In recent years, many statistical software including the JMP/SAS Clinical software which launched by SAS Company itself, with the many features combined of SAS and JMP software and dedicated in the statistical analysis of clinical trials are launched to the market. Some of those are not only powerful and easy to operate, but also gradually recognized by the drugs audit agencies. Their features fit well with the demand of development of future clinical trials, and represent trend of the development of statistical software used in clinical trials. But SAS software is still as a mainstream statistical software at this stage and widely used in the statistical analysis of clinical trial work.Therefore this study focus on the development status of clinical trials, and exploratory research and develop a suite of visualized SAS drawing program, combining the Visual Basic and SAS to achieve the simplification of the mapping work of the SAS software to try to improve the efficiency of the statistical analysis work of actual clinical trials in the present stage. Exploration and research work includes the following three aspects:1. Use the SAS9.2as the core of the program, and the SAS macro program as the carrier to build a flexible and practical statistical graphics templates.2. Use the Visual Basic6.0software as a platform to build the drawing program’s user interface.3. Make the VB interface and SAS software interactive, create a SAS drawing program with menu operation mode to draw statistical graphics of clinical trials which can comparable with those come out as SAS programming way.After the end of the above studies, it can be found that after using actual clinical trial data to do the test, the drawing program can work out most of the statistical graphics which often used in statistical work in clinical trials, and can greatly contribute to clinical statistics programming efficiency with significance of promotion. |
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