Toward Distributed Conduction of Large-Scale Studies in Radiation Therapy and Oncology: Open-Source System Integration Approach

The conduct of multicenter studies in the field of radiation therapy and oncology is one of the key prerequisites for stimulating translational research and accelerating the application of healthcare innovations into day to day patient treatment. To effectively run such studies, the participating research institutions need access to radiotherapy-specific information technology (IT), which enables collection of case report forms (eCRFs) linked with medical imaging and treatment planning data. Existing commercial systems that provide multimodal data collection features may fit for industry funded clinical trials but do not consider academia needs for long-lasting and affordable IT infrastructure. This paper presents an alternative way for development of a sustainable clinical research IT platform based on open-source systems. The platform design is driven by an integration of its core components, namely, electronic data capture system (EDC), medical image archive (PACS), and patient identity management system (PIDG). Three deployment scenarios are described that allow setting up the platform in a central, virtually hosted or decentralized environment. The first production implementation of this infrastructure was established as RadiationDosePlan-Image/Biomarker-Outcome-platform (RadPlanBio) in September 2013. It is maintained by the German Cancer Consortium (DKTK), Dresden and the German Cancer Research Center (DKFZ), Heidelberg. Until now, it manages 9 studies across 11 sites with 600 enrolled subjects. This paper shows how the integration of open-source systems can drive the development of sustainable clinical research IT environment supporting translational research projects in the field of radiation therapy and oncology.