title: Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.
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.
authors.affiliation: Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow G12 8QQ, UK.
authors.forename: Colin
authors.initials: C
authors.lastname: McCowan
authors.affiliation: Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow G12 8QQ, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Thomson
authors.affiliation: Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Central Teaching Hospital SP CSK, 1A Banacha Street, 02 097 Warsaw, Poland.
authors.forename: Cezary A
authors.initials: CA
authors.lastname: Szmigielski
authors.affiliation: The European Institute for Health Records (EuroRec), 9830 Sint-Martens-Latem, Belgium.
authors.forename: Dipak
authors.initials: D
authors.lastname: Kalra
authors.affiliation: UTOPIAN, University of Toronto, North York General Hospital, 4001 Leslie Street, Room GS-70, Toronto, Canada ON M2K 1E1.
authors.forename: Frank M
authors.initials: FM
authors.lastname: Sullivan
authors.affiliation: Department of Medical Informatics, Friedrich-Alexander University Erlangen-Nürnberg, 91058 Erlangen, Germany.
authors.forename: Hans-Ulrich
authors.initials: HU
authors.lastname: Prokosch
authors.affiliation: Institute of Medical Informatics, University of Münster, 48149 Münster, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Dugas
authors.affiliation: Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow G12 8QQ, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002986:Clinical Trials as Topic / Q000379:methods*; D057286:Electronic Health Records / Q000706:statistics & numerical data*; D005060:Europe; D005240:Feasibility Studies; D006282:Health Personnel / Q000706:statistics & numerical data*; D006801:Humans; D018579:Patient Selection