Development Of Data Management Software For Vaccine Clinical Trials

ObjectiveData management is an important step in clinical trials of vaccines. The accuracy and reliability of the conclusion of the study are linked to the statistical analysis, which is determined by the quality of data management. In order to improve the data management in vaccine clinical trial, we continue to develop the statistical analysis plan, standard database, automatic text output, based on the existing research, to achieve the standardization, standardization, automation of data management process, make it adaptable to different data structure.MethodsAccording to the principle developed by the Clinical Data Interchange Standards Consortium (CDISC), using the naming rules of Study Data Tabulation Model (SDTM) is the foundation of standardization. We can write various functions in the data management process to fit automation requirement, with the SAS software and the AF macro program. We reviewed different clinical trials in data structures, variables, analysis, text produce, figure the fixed parts and alterable parts, make templates to achieve standardization.In the base of SAS and AF interface platform, with the automatic coding and blind review function integrated and parameters configuration through the use of external Excel, which is powerful at editing, well docked with SAS and easy to store and exchange characteristics, to develop statistical analysis plan design, the SDTM domain extraction, text for database locking and unblinded, which makes the data management steps covered, and add some tools for data processing, to achieve automation for data management and make a software of complete function.ResultsImproved the electronic CRF database and application of SDTM in clinical trials of vaccine, and provided an update route for the future improvement. By writing a number of macro to fit different extraction rules, the software is able to extract the domain of demographic, safety, immunogenicity, et al. On the summary of statistical tables of different experiments, method for making a set of statistical analysis plan forms has been concluded. With the use of external Excel to configurate parameters, information in statistical analysis form and list of tables can be neatly settled. By the RTF output processing technology, the statistical analysis plan output is largely automated. On the summary of texts which are needed to write in several steps, a set of template for these texts has been concluded, using the SAS template specification for RTF output control and the RTF code editing, the text from RTF output is nearly the same with that is done in Office manually.DiscussionThe application of SDTM in Chinese clinical trials are still in the exploratory stage, a part of variables, the data structure is still in the collection of expert opinion, and the application of SDTM in vaccine trial will face more problems than that in medicine. The study and application of the SDTM standard is a long process. So the design of variables for domain extraction and the rules are not written into the software program itself, but prepare several kinds of macro program of extraction methods. The information which is required in extraction such as variable type and name is written in an external Excel file according to the standard of SDTM, and with the application in the different trials and more in-depth understanding of SDTM, can be continue to expand.There are also some problems need to be improved in statistical analysis planning and handover for locking and unblinding which has reached a good level of automation. The electronic dictionary for CRF data by CSPro software has become the short board of data management process due to some bugs in data exporting, will be the focus of future improvement and development of data management software.ConclusionWith the use of CDISC standard, to lay the foundation for specification of data acquisition and storage of clinical trials of vaccines in the data structure, the name of the variable, the variable type and so on. On this basis, a lot of programming and the frame have been written by SAS macro and AF interface, that realizes automation for domain extraction, while guarantee the adaptation in the future with the update of SDTM version. Module of statistical analysis plan complete to output statistical forms in a high level, using Excel to solve the problems of parameter information caused by the difference of age group, symptoms, inoculation in different trials. The text output of automation improves efficiency and saves manpower and time, reduces the possibility of error in artificial editing. At the same time, standard text is formatted. The software is based on SAS/AF, which realize the connection between parameters configuration on interface and the background of macro program entrance, is convenient for the professional staff, support for the development of vaccine clinical trial data management automation.