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Sharing and reuse of individual participant data from clinical trials: principles and recommendations
  1. Christian Ohmann1,
  2. Rita Banzi2,
  3. Steve Canham3,
  4. Serena Battaglia4,
  5. Mihaela Matei4,
  6. Christopher Ariyo5,
  7. Lauren Becnel6,
  8. Barbara Bierer7,
  9. Sarion Bowers8,
  10. Luca Clivio2,
  11. Monica Dias9,
  12. Christiane Druml10,
  13. Hélène Faure11,
  14. Martin Fenner12,
  15. Jose Galvez13,
  16. Davina Ghersi14,
  17. Christian Gluud15,
  18. Trish Groves16,
  19. Paul Houston6,
  20. Ghassan Karam17,
  21. Dipak Kalra18,
  22. Rachel L Knowles19,
  23. Karmela Krleža-Jerić20,
  24. Christine Kubiak4,
  25. Wolfgang Kuchinke21,
  26. Rebecca Kush22,23,
  27. Ari Lukkarinen5,
  28. Pedro Silverio Marques24,
  29. Andrew Newbigging25,26,
  30. Jennifer O’Callaghan27,
  31. Philippe Ravaud28,
  32. Irene Schlünder29,
  33. Daniel Shanahan11,30,
  34. Helmut Sitter31,
  35. Dylan Spalding32,
  36. Catrin Tudur-Smith33,
  37. Peter van Reusel6,
  38. Evert-Ben van Veen34,35,
  39. Gerben Rienk Visser36,
  40. Julia Wilson8,
  41. Jacques Demotes-Mainard4
  1. 1 European Clinical Research Infrastructure Network (ECRIN), Düsseldorf, Germany
  2. 2 IRCCS – Istituto di Ricerche Farmacologiche ’Mario Negri' (IRFMN), Milan, Italy
  3. 3 Canham Information Systems, Surrey, UK
  4. 4 European Clinical Research Infrastructure Network (ECRIN), Paris, France
  5. 5 CSC IT Center for Science, Espoo, Finland
  6. 6 Clinical Data Interchange Standards Consortium, Austin, Texas, USA
  7. 7 MRCT Center of BWH and Harvard, Brigham and Women’s Hospital and Harvard University, Boston, Massachusetts, USA
  8. 8 Wellcome Trust Sanger Institute, Cambridge, UK
  9. 9 European Medicines Agency, London, UK
  10. 10 Ethics, Collections and History of Medicine of the Medical University of Vienna, Vienna, Austria
  11. 11 BioMed Central, London, UK
  12. 12 DataCite, Hanover, Germany
  13. 13 National Institutes of Health/National Cancer Institute, Bethesda, Maryland, USA
  14. 14 National Health and Medical Research Council, Watson, Australian Capital Territory, Australia
  15. 15 Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
  16. 16 BMJ Editorial, BMJ Editorial BMA House, London, UK
  17. 17 World Health Organisation/Organisation mondiale de la santé, Geneva, Switzerland
  18. 18 The European Institute for Innovation through Health Data, Ghent, Belgium
  19. 19 Medical Research Council, London, UK
  20. 20 Ottawa Group-IMPACT, Montreal, Quebec, Canada
  21. 21 Coordination Centre for Clinical Trials, Heinrich Heine University, Düsseldorf, Germany
  22. 22 Catalysis, Austin, Texas, USA
  23. 23 Formerly Clinical Data Interchange Standards Consortium, Austin, Texas, USA
  24. 24 European AIDS Treatment Group (EATG), Lisbon, Portugal
  25. 25 TrialGrid Limited, London, UK
  26. 26 Formerly Medidata Solutions, Hammersmith, UK
  27. 27 Wellcome Trust, London, UK
  28. 28 METHODS Team, INSERM UMR-S 1153, Paris, France
  29. 29 Biobanking and BioMolecular Resources Research Infrastructure (BBMRI), Berlin, Germany
  30. 30 Faculty of 1000, London, UK
  31. 31 Institute of Theoretical Surgery, Philipps University, Marburg, Germany
  32. 32 European Molecular Biology Laboratory, European Bioinformatics Institute, EMBL-EBI, Hinxton, UK
  33. 33 Department of Biostatistics, University of Liverpool, Liverpool, UK
  34. 34 MLC Foundation, Den Haag, The Netherlands
  35. 35 Medlawconsult, The Hague, The Netherlands
  36. 36 Trial Data Solutions, Amsterdam, The Netherlands
  1. Correspondence to Christian Ohmann; Christian.Ohmann{at}uni-duesseldorf.de

Abstract

Objectives We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach.

Design and methods This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European.

Outcome We developed principles and practical recommendations on how to share data from clinical trials.

Results The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata.

Conclusions The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.

  • clinical trials
  • individual participant data
  • data sharing
  • consensus conference

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors CO, RB, SC, SeB and MM were members of the core group. The core group’s responsibilities were to establish the multistakeholder taskforce, draft intermediate versions of this report, organise and manage the consensus workshops, coordinate the subgroups, and release the final version of the report and paper. HS acted as independent facilitator of the consensus process, chaired the face-to-face meetings together with CO and was responsible for the methods section of the paper. CA, LB, BB, SaB, LC, MD, CD, HF, MF, JG, DG, CG, TG, PH, GK, DK, RLK, KK-J, CK, WK, RK, AL, PSM, AN, JO, PR, IS, DaS, HS, DyS, CT-S, PvR, E-BvV, GRV and JW were members of the multistakeholder task force, attended at least one of the consensus meetings, provided written feedback during the consensus process to draft manuscripts, and approved the final manuscript. JD-M attended all consensus meetings, was responsible for alignment of the work with the H2020-CORBEL project and approved the final manuscript.

  • Funding This project has received funding from the European Union’s Horizon 2020 research and innovation programme (CORBEL, under grant agreement n° 654248).

  • Disclaimer The views expressed by MD in this article are the personal views of the author and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

  • Competing interests TG is the editor-in-chief of BMJ Open, the journal that publishes this article. During the paper evaluation she recused herself from the peer review and decision-making process. BB reports various unrestricted gifts (see) supporting travel and effort; grants from Laura and John Arnold Foundation and the Greenwall Foundation during the conduct of the study; and non-financial support from Vivli, outside the submitted work. RK reports she was Founder of CDISC and President during the development of the submitted work. DaS was employed by BioMed Central at the time of the consensus process.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No further data available to share.

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