Using electronic health records to support clinical trials: a report on stakeholder engagement for EHR4CR

Mccowan, C. , Thomson, E., Szmigielski, C. A., Kalra, D., Sullivan, F. M., Prokosch, H.-U., Dugas, M. and Ford, I. (2015) Using electronic health records to support clinical trials: a report on stakeholder engagement for EHR4CR. BioMed Research International, 2015, 707891. (doi: 10.1155/2015/707891) (PMID:26539523) (PMCID:PMC4619877)

Abstract

Background. 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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Thomson, Miss Elizabeth and Ford, Professor Ian and Mccowan, Professor Colin
• Authors: Mccowan, C., Thomson, E., Szmigielski, C. A., Kalra, D., Sullivan, F. M., Prokosch, H.-U., Dugas, M., and Ford, I.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
• Journal Name: BioMed Research International
• Publisher: Hindawi Publishing Corporation
• ISSN: 2314-6133
• ISSN (Online): 2314-6141
• Copyright Holders: Copyright © 2015 Colin McCowan et al.
• First Published: First published in BioMed Research International 2015:707891
• Publisher Policy: Reproduced under a Creative Commons License