DEFINITION OF A COMMON DATA SET FOR CLINICAL-TRIALS IN PEDIATRIC ONCOLOGY

Large multicenter trials have made a major contribution to the improvement of treatment results in childhood malignancies. Coordination and central documentation ensure the quality of treatment and permit clinical and scientific investigations. This kind of cooperation requires a vast amount of documentation, which by itself has become a critical factor in answering important medical questions. The problems result from non-standardized documentation systems in different studies, from insufficient integration of clinical work and documentation and from a lack of application of modern computer based data management systems. The working group ,,Applied Informatics'' of the German ,,Gesellschaft fur Padiatrische Onkologie und Hamatologie (GPOH)'' has started a project to create an uniform basic data set for the German pediatric oncology group. Relevant initial diagnostic data, information about planned and realized treatment as well as data concerning negative event had to be standardized. A minimal common data set with a substantially reduced documentation, which is applicable for all patients and trials, would have failed to fulfil the clinical as well as the research needs. The data set presented here is a detailed information structure introduced as a basic tool for the improvement of data management in the German pediatric oncology group. This first version of the basic data set will need further development, since some of the problems still need to be resolved and the requirements for such data pools are changing. Based on this data set new computer software and clinical information systems have to be developed to enable documentation and processing of all clinical and study related data.