Managing multicentre clinical trials with open source

Abstract

BACKGROUND Multicentre clinical trials are challenged by high administrative burden, data management pitfalls and costs. This leads to a reduced enthusiasm and commitment of the physicians involved and thus to a reluctance in conducting multicentre clinical trials. OBJECTIVE The purpose of this study was to develop a web-based open source platform to support a multi-centre clinical trial. METHODS We developed on Drupal, an open source software distributed under the terms of the General Public License, a web-based, multi-centre clinical trial management system with the design science research approach. RESULTS This system was evaluated by user-testing and well supported several completed and on-going clinical trials and is available for free download. CONCLUSION Open source clinical trial management systems are capable in supporting multi-centre clinical trials by enhancing efficiency, quality of data management and collaboration.