The Study And Development Of Visualization System For The Results Of Statistical Analysis In Vaccine Clinical Trials

Objective Clinical trial is an essential part of the vaccine development process.In order to safeguard the rights of the subjects and ensure the authenticity and reliability of the research data,the regulatory authorities in various countries have made specific regulations on the registration and review process of clinical trials to ensure that good and reasonable evaluation policies and procedures can be fully supported and effectively supervised in vaccine clinical trials.The statistical work involved in vaccine clinical trials involves participation in the design of clinical trial proposal,data management,and statistical analysis.Statistical analysis must be performed by experienced statisticians with authoritative software SAS.Since the graph in version before SAS 9.2 is not easy to implement and the appearance of the graph is not accepted widely and the tabulation can give more detailed information,so the statistical analysis report rarely gives a graphic display.During the review process,the vaccine clinical trial results have a large amount of review work,so how to use the graph to express information clearly and intuitively is worth studying.Method If SAS is fully utilized to express analytical datasets representing different results in a graph that meets the requirements of intuitive simplicity and aesthetic,it can not only achieve rapid and standardized interface operations,but also can achieve effective communication with statisticians,researchers and review experts,thereby accelerating the progress of the review.In order to solve the above problems,the visualization system for statistical analysis of vaccine clinical trials needs to be researched and developed.This paper builds the visualization system for statistical analysis results of vaccine clinical trials based on SAS.The key principles and methods for constructing the system are described in detail.The research contents mainly include: GTL language in SAS ODS Graphics System,SAS macro program and its combination with Excel,SAS/AF module includes AF frame and SCL language.It is necessary to know the basic concepts of vaccine clinical trials even drug clinical trials,SOP,data management,statistical analysis,SAS mapping and the way of graphic output.To understand the problems existing in the review of vaccine clinical trials in China,such as lack of clear and intuitive visual graphic content in the statistical analysis reports,most of which are tedious tabular data,may seem time-consuming and laborious to the communication with statisticians,researchers and review experts.Moreover,a large number of tabular data and statistical analysis results will extend the review process,which is a loss to the sponsor and even those who wish to use the vaccine at an early date.Results Learn about SAS/BASE,SAS macro and its combination with Excel.Finish the preparation of data processing macro for different statistical analysis datasets.Learn about the GTL language in SAS ODS Graphics System and then master the use of key sentences needed for statistical mapping,customize different statistical graph templates for different modules of vaccine clinical trials and integrate this template with the data processing macro into a larger macro program.High-customized target analysis variables,picture formats and output paths are achieved.Learn about SAS/AF module and understand the operation control of the SCL language on the AF frame and the method in which the SAS macro is invoked,setting up the visualization system for vaccine clinical trials.The actual datasets of different vaccine clinical trials are used to test the system to demonstrate the expected graphic style.Conclusions The SAS/AF module is used to build the visualization system for statistical analysis of vaccine clinical trials.The macro programs for statistical analysis and statistical graph are inserted into the background of the interface.SCL language is used to control the interface and the implement of macro programs.The main functions of the interface include four parts: visualization of baseline data,immunogenic data,safety data and combined drug/combined vaccine data,which correspond to the table information in the statistical analysis report.These are the major concerns for review experts.The visual results are concise and beautiful.The system is tested using the baseline,immunogenicity,and safety analysis datasets of the two vaccine clinical trial projects.The results are satisfactory and the presentation information is clearer and more beautiful than tabulation.