Evaluating clinical trial management systems: a simulation approach

Céline Bérard (), Martin Cloutier and Luc Cassivi
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Céline Bérard: COACTIS - COnception de l'ACTIon en Situation - UL2 - Université Lumière - Lyon 2 - UJM - Université Jean Monnet - Saint-Étienne, UL2 - Université Lumière - Lyon 2
Martin Cloutier: UQAM - Université du Québec à Montréal = University of Québec in Montréal
Luc Cassivi: UQAM - Université du Québec à Montréal = University of Québec in Montréal

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Abstract: Purpose - If the use of IT supporting clinical trial projects offers opportunities to optimize the underlying information management process, the intricacy of the identification and evaluation of relevant IT options is generally seen as a complex task in healthcare. This paper hence examines the problem of ex-ante information system evaluation, and aims at assessing the impact of IT on the information management process underlying clinical trials. Design/methodology/approach - Combining UML and system dynamics modeling, a simulation model for evaluating IT was developed. This modeling effort relies on a case study conducted in a clinical research organization, which, at that time, faced an IT investment dilemma. Findings - Some illustrative results of sensitivity analyzes conducted on error rates in clinical data transmission are presented. These simulation results allow for quantifying the impact of different IT options on human resources' efforts, time delays and costs of clinical trials projects. Notably, the results show that although the technology has no real influence on the duration of a clinical trial project, it impacts the number of projects that can be carried out simultaneously. Originality/value - The research provides insights into the development of an innovative approach appropriate to the evaluation of IT supporting clinical trials, through the use of a mixed-method based on qualitative and quantitative modeling. The results illustrate two critical issues addressed in the IS literature: (1) the necessity to extend IT evaluation beyond the quantitative-qualitative dichotomy, (2) the role of evaluation in organizational learning, and in learning about business dimensions.

Keywords: Healthcare information technology; Clinical trials; Information system evaluation; UML; System dynamics (search for similar items in EconPapers)
Date: 2012
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Published in Industrial Management and Data Systems, 2012, 112 (1), pp.146-164

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:halshs-00658083

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