title: UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns.
abstract: OBJECTIVE
  Evaluate current data sharing activities of UK publicly funded Clinical Trial Units (CTUs) and identify good practices and barriers.
  
  
  METHODS
  Web-based survey of Directors of 45 UK Clinical Research Collaboration (UKCRC)-registered CTUs.
  
  
  RESULTS
  Twenty-three (51%) CTUs responded: Five (22%) of these had an established data sharing policy and eight (35%) specifically requested consent to use patient data beyond the scope of the original trial. Fifteen (65%) CTUs had received requests for data, and seven (30%) had made external requests for data in the previous 12 months. CTUs supported the need for increased data sharing activities although concerns were raised about patient identification, misuse of data, and financial burden. Custodianship of clinical trial data and requirements for a CTU to align its policy to their parent institutes were also raised. No CTUs supported the use of an open access model for data sharing.
  
  
  CONCLUSIONS
  There is support within the publicly funded UKCRC-registered CTUs for data sharing, but many perceived barriers remain. CTUs are currently using a variety of approaches and procedures for sharing data. This survey has informed further work, including development of guidance for publicly funded CTUs, to promote good practice and facilitate data sharing.
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Hopkins
authors.affiliation: MRC Clinical Trials Unit, University College London, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Sydes
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Teviot Place, Edinburgh, EH8 9AG, UK.
authors.forename: Gordon
authors.initials: G
authors.lastname: Murray
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Psychological Sciences, Block B Waterhouse Building, Brownlow Street, Liverpool L69 3GL, UK.
authors.forename: Kerry
authors.initials: K
authors.lastname: Woolfall
authors.affiliation: All-Ireland Hub for Trials Methodology Research, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Health Sciences Building, 97 Lisburn Road, Belfast, BT9 7BL, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Clarke
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
authors.forename: Paula
authors.initials: P
authors.lastname: Williamson
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK. Electronic address: Cat1@liv.ac.uk.
authors.forename: Catrin
authors.initials: C
authors.lastname: Tudur Smith
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics*; D003219:Confidentiality; D005378:Financial Support; D006801:Humans; D033181:Information Dissemination / Q000379:methods*; D016134:Organizational Policy; D012107:Research Design; D011795:Surveys and Questionnaires; D006113:United Kingdom
keywords: Clinical trial; Clinical trial unit; Data sharing; IPD; Individual participant data; Publicly funded