Show simple item record

Files in this item

Thumbnail

Item metadata

dc.contributor.authorMcCowan, Colin
dc.contributor.authorThomson, Elizabeth
dc.contributor.authorSzmigielski, Cezary A
dc.contributor.authorKalra, Dipak
dc.contributor.authorSullivan, Frank M.
dc.contributor.authorProkosch, Hans-Ulrich
dc.contributor.authorDugas, Martin
dc.contributor.authorFord, Ian
dc.date.accessioned2018-02-27T11:30:06Z
dc.date.available2018-02-27T11:30:06Z
dc.date.issued2015
dc.identifier.citationMcCowan , C , Thomson , E , Szmigielski , C A , Kalra , D , Sullivan , F M , Prokosch , H-U , Dugas , M & Ford , I 2015 , ' Using electronic health records to support clinical trials : a report on stakeholder engagement for EHR4CR ' , BioMed Research International , vol. 2015 , 707891 . https://doi.org/10.1155/2015/707891en
dc.identifier.issn2314-6133
dc.identifier.otherPURE: 249969478
dc.identifier.otherPURE UUID: bb81a0d6-9d77-4e9f-834c-ba2b3f4779a4
dc.identifier.otherPubMed: 26539523
dc.identifier.otherPubMedCentral: PMC4619877
dc.identifier.otherScopus: 84945957227
dc.identifier.urihttp://hdl.handle.net/10023/12797
dc.descriptionThe research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement number 115189, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007–2013) and EFPIA companies’ in kind contribution.en
dc.description.abstractBACKGROUND: The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. METHODS: Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. RESULTS: 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. CONCLUSIONS: There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.
dc.format.extent8
dc.language.isoeng
dc.relation.ispartofBioMed Research Internationalen
dc.rightsCopyright © 2015 Colin McCowan et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.en
dc.subjectR Medicine (General)en
dc.subjectZA4050 Electronic information resourcesen
dc.subjectNDASen
dc.subject.lccR1en
dc.subject.lccZA4050en
dc.titleUsing electronic health records to support clinical trials : a report on stakeholder engagement for EHR4CRen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.contributor.institutionUniversity of St Andrews.Population and Behavioural Science Divisionen
dc.identifier.doihttps://doi.org/10.1155/2015/707891
dc.description.statusPeer revieweden


This item appears in the following Collection(s)

Show simple item record