Intended for healthcare professionals

CCBYNC Open access

Data sharing statements for clinical trials

BMJ 2017; 357 doi: (Published 05 June 2017) Cite this as: BMJ 2017;357:j2372

Chinese translation


  1. Darren B Taichman, executive deputy editor, Annals of Internal Medicine,
  2. Peush Sahni, past president, World Association of Medical Editors,
  3. Anja Pinborg, scientific editor in chief,, Ugeskrift for Laeger,
  4. Larry Peiperl, chief editor, PLOS Medicine,
  5. Christine Laine, editor in chief, Annals of Internal Medicine,
  6. Astrid James, deputy editor, Lancet,
  7. Sung-Tae Hong, editor in chief, Journal of Korean Medical Science,
  8. Abraham Haileamlak, editor in chief , Ethiopian Journal of Health Sciences,,
  9. Laragh Gollogly, editor, Bulletin of the World Health Organization,
  10. Fiona Godlee, editor in chief, The BMJ,
  11. Frank A Frizelle, editor in chief, New Zealand Medical Journal,
  12. Fernando Florenzano, editor, Revista Médica de Chile,
  13. Jeffrey M Drazen, editor in chief, New England Journal of Medicine,
  14. Howard Bauchner, editor in chief, JAMA and the JAMA Network,
  15. Christopher Baethge, chief scientific editor, Deutsches Ärzteblatt and Deutsches Ärzteblatt International,
  16. Joyce Backus, associate director for library operations, National Library of Medicine

A requirement of the International Committee of Medical Journal Editors

The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups.1 Some applauded the proposals while others expressed disappointment that they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers.

It is encouraging that data sharing is already occurring in some settings. Over the past year, however, we have learnt that the challenges are substantial and the requisite mechanisms are not in place to mandate universal data sharing at this time. Although many issues must be addressed for data …

View Full Text