The Cochrane Collaboration Supports Free Access to all Data from all Clinical Trials

The Cochrane Collaboration is committed globally to providing the most reliable evidence of the benefits and harms of healthcare interventions. It publishes systematic reviews in The Cochrane Library and updates these regularly.

Selective reporting of trial results occurs frequently, leading to exaggerated findings of the beneficial effects of healthcare interventions and underestimates of their harms. As a consequence, many patients are unknowingly treated with interventions that have little or no effect, and may be harmed unnecessarily. This is unethical ¹ and has been said to violate the implicit contract between healthcare researchers and patients, where the aim of research is to improve treatment of future patients.

To ensure that all data from all clinical trials become publicly available, without undue delay, The Cochrane Collaboration calls for:

• All randomised clinical trials to be registered at their inception, before recruitment of the first participant (see the Cochrane statement on this here);
• All data from all randomised clinical trials, including raw anonymised individual participant data that do not allow identification of individual participants, and the corresponding trial protocols, to become publicly available free of charge and in easily accessible electronic formats;
• Governments to consider introducing legislation that makes it a requirement to provide these data from all trials to the public within 12 months from the end of the randomised phase of the trial, in accordance with most international calls for data sharing;
• Governments also to consider punitive measures for non-compliance; a requirement to continue to hold and make available core data indefinitely, or to pass such data to a central and accessible repository; and a recognition that ownership of trial data should be shared between sponsors, investigators and trial participants.

Calls for data sharing have come from a variety of international organisations, research funders, and others, including the Organisation for Economic Co-operation and Development (OECD),^2,3 the World Health Organization (WHO), the US National Institutes of Health (NIH), the Bill and Melinda Gates Foundation and the Hewlett Foundation,⁴ the US Congress,⁵ the European Commission,^6,7 the European Ombudsman,^8,9 journal editors,^{10,11,12,13,14,15} the UK Medical Research Council (MRC),¹⁶ and the Wellcome Trust.¹⁷ Such calls have mostly been restricted to publicly-funded research, but the distinction between publicly-funded research and industry-funded research is an artificial one, as the interests of the patients should override commercial interests.^8,9

Please note that this statement is currently under review and may be revised during 2012.

References:

1. Antes G, Chalmers I. Under-reporting of clinical trials is unethical. Lancet 2004;361:978.
2. OECD. Science, Technology and Innovation for the 21st Century. Meeting of the OECD Committee for Scientific and Technological Policy at Ministerial Level, 29-30 January 2004 – Final Communiqué. 30/01/2004. http://www.oecd.org/document/15/0,3343,en_2649_201185_25998799_1_1_1_1,00.html (accessed 5 October 2011).
3. Arzberger P, Schroeder P, Beaulieu A, et al. Promoting access to public research data for scientific, economic, and social development. Data Science Journal 2004;3:135–52.
4. Wellcome Trust. Sharing research data to improve public health: full joint statement by funders of health research. 10 January 2011. http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Data-sharing/... (accessed 5 October 2011).
5. U.S Department of Health and Human Services. National Institutes of Health Public Access. http://publicaccess.nih.gov/ (accessed 5 October 2011).
6. Commission of the European Communities. Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee. On scientific information in the digital age. Access, dissemination and preservation. 2007. http://ec.europa.eu/research/science-society/document_library/pdf_06/communication-022007_en.pdf (accessed 5 October 2011).
7. Commission of the European Communities. Communication from the Commission – Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No. 1901/2006. 4 February 2009.  http://ec.europa.eu/health/files/eudralex/vol-10/2009_c28_01/2009_c28_01_en.pdf (accessed 5 October 2011).
8. Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342:d2686.
9. Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials (provisionally accepted).
10. General Information for Authors. Science. http://www.sciencemag.org/site/feature/contribinfo/prep/gen_info.xhtml (accessed 5 October 2011).
11. Information for Authors. Lancet August 2011. http://download.thelancet.com/flatcontentassets/authors/lancet-information-for-authors.pdf (accessed 5 October 2011).
12. Groves T. Managing UK research data for future use. BMJ 2009;338:b1252.
13. Cowling BJ, Chan KH, Fang VJ, Fung ROP, Wai W et al. Face masks and hand hygiene to prevent influenza transmission in households: a cluster randomized trial. Ann Intern Med 2009;151:437–46.
14. PLoS One. PLoS Medicine Editorial and Publishing Policies. Sharing of Materials, Methods and Data. http://www.plosone.org/static/policies.action (accessed 5 October 2011).
15. Gøtzsche PC. We need access to all data from all clinical trials [editorial]. The Cochrane Library 2011 (5 Oct). http://www.thecochranelibrary.com/details/editorial/1359903/We-need-access-to-all-data-from-all-clinical-trials.html (accessed 5 October 2011).
16. Medical Research Council. MRC policy on data sharing and preservation. 2011. http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/Datasharinginitiative/Policy/index.htm (accessed 5 October 2011).
17. Wellcome Trust. Policy on data management and sharing. http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-statements/WTX035043.htm (accessed 5 October 2011).

5 October 2011