Literature DB >> 24517456

Managing multicentre clinical trials with open source.

Dimitri Aristotle Raptis1, Tobias Mettler, Michael Alexander Fischer, Michael Patak, Mickael Lesurtel, Dilmurodjon Eshmuminov, Olivier de Rougemont, Rolf Graf, Pierre-Alain Clavien, Stefan Breitenstein.   

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.

Mesh:

Year:  2014        PMID: 24517456     DOI: 10.3109/17538157.2013.812647

Source DB:  PubMed          Journal:  Inform Health Soc Care        ISSN: 1753-8157            Impact factor:   2.439


  5 in total

Review 1.  Key components and IT assistance of participant management in clinical research: a scoping review.

Authors:  Johannes Pung; Otto Rienhoff
Journal:  JAMIA Open       Date:  2020-10-14

2.  The Economic Burden of Postoperative Complications Predicted by the Comprehensive Complication Index® in Patients Undergoing Elective Major Hepatopancreaticobiliary Surgery for Malignancy - A Prospective Cost Analysis.

Authors:  Dimitri Aristotle Raptis; Thomas Hanna; Nikolaos Machairas; Timothy Owen; Daniel Davies; Giuseppe Kito Fusai
Journal:  In Vivo       Date:  2021 Mar-Apr       Impact factor: 2.155

3.  Experience of using an open source clinical trials data management software system in Kenya.

Authors:  Moses M Ngari; Naomi Waithira; Roma Chilengi; Patricia Njuguna; Trudie Lang; Greg Fegan
Journal:  BMC Res Notes       Date:  2014-11-26

4.  Dupuytren Disease: Is There Enough Comprehensive Patient Information on the Internet?

Authors:  Grzegorz Zuk; Katharina B Reinisch; Dimitri A Raptis; Sonia Fertsch; Merlin Guggenheim; Adrian F Palma
Journal:  Interact J Med Res       Date:  2017-06-22

5.  Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development.

Authors:  Yu Rang Park; Young Jo Yoon; HaYeong Koo; Soyoung Yoo; Chang-Min Choi; Sung-Ho Beck; Tae Won Kim
Journal:  J Med Internet Res       Date:  2018-04-24       Impact factor: 5.428

  5 in total

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