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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.

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.

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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