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Managing multicentre clinical trials with open source
Dimitri Aristotle Raptis1, Tobias Mettler, Michael Alexander Fischer
1Division of Visceral and Transplant Surgery, Swiss HPB Center, University Hospital Zurich , Zurich , Switzerland .
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.
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