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Managing multicentre clinical trials with open source


Raptis, Dimitri Aristotle; Mettler, Tobias; Fischer, Michael Alexander; Patak, Michael; Lesurtel, Mickael; Eshmuminov, Dilmurodjon; de Rougemont, Olivier; Graf, Rolf; Clavien, Pierre-Alain; Breitenstein, Stefan (2014). Managing multicentre clinical trials with open source. Informatics for health & social care, 39(2):67-80.

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.

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.

Citations

3 citations in Web of Science®
3 citations in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Visceral and Transplantation Surgery
Dewey Decimal Classification:610 Medicine & health
Date:March 2014
Deposited On:23 Jan 2015 07:07
Last Modified:05 Apr 2016 18:46
Publisher:Informa Healthcare
ISSN:1753-8157
Publisher DOI:https://doi.org/10.3109/17538157.2013.812647
PubMed ID:24517456

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