title: Electronic health records to facilitate clinical research.
abstract: Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.
authors.affiliation: National Heart and Lung Institute, Imperial College London, Royal Brompton Hospital, Sydney Street, London, SW3 6HP, UK. m.cowie@imperial.ac.uk.
authors.forename: Martin R
authors.initials: MR
authors.lastname: Cowie
authors.affiliation: Astra Zeneca R&D, Molndal, Sweden.|University of Turku, Turku, Finland.
authors.forename: Juuso I
authors.initials: JI
authors.lastname: Blomster
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: Lesley H
authors.initials: LH
authors.lastname: Curtis
authors.affiliation: Servier, Paris, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Duclaux
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
authors.affiliation: University of Münster, Münster, Germany.
authors.forename: Fleur
authors.initials: F
authors.lastname: Fritz
authors.affiliation: Daiichi-Sankyo, London, UK.
authors.forename: Samantha
authors.initials: S
authors.lastname: Goldman
authors.affiliation: GlaxoSmithKline, Stockley Park, UK.
authors.forename: Salim
authors.initials: S
authors.lastname: Janmohamed
authors.affiliation: Boehringer-Ingelheim, Pharma GmbH & Co KG, Ingelheim, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kreuzer
authors.affiliation: Optum International, London, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Leenay
authors.affiliation: Bayer Pharma, Berlin, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Michel
authors.affiliation: Pfizer Ltd., Surrey, UK.
authors.forename: Seleen
authors.initials: S
authors.lastname: Ong
authors.affiliation: Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
authors.forename: Jill P
authors.initials: JP
authors.lastname: Pell
authors.affiliation: Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Mary Ross
authors.initials: MR
authors.lastname: Southworth
authors.affiliation: Campbell University College of Pharmacy and Health Sciences, Campbell, NC, USA.
authors.forename: Wendy Gattis
authors.initials: WG
authors.lastname: Stough
authors.affiliation: Edwards LifeSciences, Nyon, Switzerland.
authors.forename: Martin
authors.initials: M
authors.lastname: Thoenes
authors.affiliation: INSERM, Centre d'Investigation Clinique 9501 and Unité 961, Centre Hospitalier Universitaire, Nancy, France.|Department of Cardiology, Nancy University, Université de Lorraine, Nancy, France.
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.affiliation: Glaxo Smith Kline, King of Prussia, Pennsylvania, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Zalewski
mesh_terms: D022126:Access to Information; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods*; D057186:Comparative Effectiveness Research / Q000941:ethics / Q000379:methods*; D003219:Confidentiality; D000068598:Data Accuracy; D057225:Data Mining / Q000941:ethics; D057286:Electronic Health Records / Q000941:ethics; D006801:Humans; D008498:Medical Record Linkage; D012107:Research Design; D018511:Systems Integration
keywords: Cardiovascular diseases; Clinical trials as topic; Electronic health records; Pragmatic clinical trials as topic