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Challenges when introducing ePRO in large clinical studies – a case study
Växjö University, Faculty of Mathematics/Science/Technology, School of Mathematics and Systems Engineering.
2008 (English)Independent thesis Advanced level (degree of Master (One Year)), 10 credits / 15 HE creditsStudent thesis
Abstract [en]

Many pharmaceutical companies are using different information technology applications to support their main business and so do AstraZeneca. The use of IT during the clinical study phase has increased and the term electronic Patient Reported Outcomes, ePRO, is regularly used in this context. When using ePRO the patients report their data with help of a handheld computer. The pharmaceutical company can then see the patients progress via a web portal.

AstraZeneca R&D in Mölndal is coordinating two large phase-II studies with about 2800 patients in 10 different countries. The studies are turning to its end and they have been using an ePRO-solution. In these two studies there has been some trouble with the application service provider. The main mission with this master thesis is to look at the question what to avoid and how to achieve success with ePRO in the clinical research process. It seems like there is some interesting differences between the theoretical framework and the empirical findings.

There are some points that are crucial when it comes to achieving success using ePRO in clinical studies: the preparation and planning phase, education, technology, system integration and knowledge exchange.

Place, publisher, year, edition, pages
2008.
Keyword [en]
PRO, ePRO, clinical studies
National Category
Information Systems
Identifiers
URN: urn:nbn:se:vxu:diva-2090OAI: oai:DiVA.org:vxu-2090DiVA, id: diva2:205983
Uppsok
samhälle/juridik
Available from: 2008-06-10 Created: 2008-06-10 Last updated: 2018-01-13Bibliographically approved

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