IT Infrastructure for Merging Data from Different Clinical Trials and Across Independent Research Networks

• Published in: Studies in health technology and informatics Vol. 228; p. 287
• Main Authors: Hayn, Dieter, Falgenhauer, Markus, Kropf, Martin, Nitzlnader, Michael, Welte, Stefan, Ebner, Hubert, Ladenstein, Ruth, Schleiermacher, Gudrun, Hero, Barbara, Schreier, Günter
• Format: Journal Article
• Language: English
• Published: Netherlands 01.01.2016
• Subjects: Clinical Trials as Topic; Data Collection - methods; Humans; Information Management - organization & administration; Information Systems; Software
• ISSN: 0926-9630
• DOI: 10.3233/978-1-61499-678-1-287

Opsoclonus Myoclonus Syndrome (OMS) is a rare disease in children which is often associated with neuroblastoma and, therefore, requires treatment by pediatric neurologists and oncologists. The ongoing OMS trial investigates questions related to OMS and potentially underlying neuroblastomas. To support this trial with an adequate IT infrastructure, linkage of neuroblastoma research databases with the OMS electronic data capture (EDC) system was required. Therefore, an EDC system for the OMS trial was developed and integrated into the research infrastructure of the European Network for Cancer Research in Children and Adolescents (ENCCA) project. Application of ENNCA's pseudonymization concept enabled linkage of the OMS trial with neuroblastoma trials from two different scientific societies, while being compliant with current data protection regulations. Linkage of the neurological and the oncological domain could successfully be demonstrated and a promising concept for secondary use of the data of both domains has been developed, proofing the broad potential of the concepts for cross-domain research as promoted in the ENCCA project.