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On Selecting a Clinical Trial Management System for Large Scale, Multi-Centre, Multi-Modal Clinical Research Study

2011; IOS Press; Linguagem: Inglês

10.3233/978-1-60750-791-8-89

1879-8365

Hugo Leroux, Simon McBride, Simon Gibson,

Scientific Computing and Data Management

Clinical research studies offer many challenges for their supporting information systems. AIBL assembled 1112 participants who volunteered crucial information for a comprehensive study on neurodegenerative diseases. This paper discusses the shortcomings of the clinical trial management system chosen to record the results of the study. A set of guidelines was devised and a critique of five systems ensued. OpenClinica was selected as the most appropriate option. The main contribution of this paper is: (i) proposing a set of guidelines to determine the appropriateness of Clinical Trial Management Systems (CTMS) solution; (ii) providing a brief critique of existing commercial and open-sourced CTMS; and (iii) alluding to some data migration issues and providing cues on how to address them. We conclude that open-source CTMS are viable alternatives to the more expensive commercial systems to conduct, record and manage clinical studies.