Development of a novel open source web-based multi-centric clinical trial management system

Abstract

Multicentre clinical trials are challenged by a substantially increased administrative burden, data management pitfalls and high costs. This all leads to a reduced enthusiasm and commitment of the physicians involved and thus to a reduction in conducting such studies. We successfully developed a novel, open source web-based, multi-centre clinical trial management system with the design science research approach, to support a double blind randomised clinical trial investigating the inter-rated agreement among radiologists in diagnosing primary liver tumours by magnetic resonance imaging (MRI).