title: How should individual participant data (IPD) from publicly funded clinical trials be shared?
abstract: BACKGROUND
  Individual participant data (IPD) from completed clinical trials should be responsibly shared to support efficient clinical research, generate new knowledge and bring benefit to patients. The Medical Research Council (MRC) Hubs for Trials Methodology Research (HTMR) has developed guidance to facilitate the sharing of IPD from publicly funded clinical trials.
  
  
  METHODS
  Development of the guidance was completed over four phases which included a focussed review of policy documents, a web-based survey of the UK Clinical Research Collaboration (CRC) Registered Clinical Trials Units (CTU) Network, participation of an expert committee and an open consultation with the UKCRC Registered CTU Network. The project was funded by the MRC HTMR (MR/L004933/1-R39).
  
  
  RESULTS
  Good practice principles include: (i) the use of a controlled access approach, using a transparent and robust system to review requests and provide secure data access; (ii) seeking consent for sharing IPD from trial participants in all future clinical trials with adequate assurance that patient privacy and confidentiality can be maintained; and (iii) establishing an approach to resource the sharing of IPD which would include support from trial funders, sponsor organisations and users of IPD. The guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UKCRC Registered CTU Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance.
  
  
  CONCLUSIONS
  Implementation of these principles will improve transparency, increase the coherent sharing of IPD from publicly funded trials, and help publicly funded trials to adhere to trial funder and journal requirements for data sharing.
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, Liverpool, L69 3GL, UK. cat1@liv.ac.uk.
authors.forename: C
authors.initials: C
authors.lastname: Tudur Smith
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, Liverpool, L69 3GL, UK.
authors.forename: C
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: M R
authors.initials: MR
authors.lastname: Sydes
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: K
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: M
authors.initials: M
authors.lastname: Clarke
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Teviot Place, Edinburgh, EH8 9AG, UK.
authors.forename: G
authors.initials: G
authors.lastname: Murray
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, Liverpool, L69 3GL, UK.
authors.forename: P
authors.initials: P
authors.lastname: Williamson
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence*; D005378:Financial Support; D017408:Guidelines as Topic; D006801:Humans; D033181:Information Dissemination; D011050:Policy Making