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The future of clinical trials: data sharing
  1. Joshua A Hirsch
  1. Correspondence to Dr Joshua A Hirsch, NeuroEndovascular Program, Massachusetts General Hospital, 55 Fruit Street, Gray 241B, Boston, MA 02114, USA; hirsch{at}snisonline.org

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Introduction

Simultaneously, in a variety of premier medical journals, an exciting proposal was recently published. In their piece entitled ‘Sharing Clinical Trial Data—A Proposal from the International Committee of Medical Journal Editors’, Taichman et al1 point to a more collaborative future for researchers and academicians.

The International Committee of Medical Journal Editors (ICMJE) describes itself as a ‘small working group of general medical journal editors, whose participants meet annually and fund their own work on the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals’. The current members of the ICMJE are Annals of Internal Medicine, British Medical Journal, Canadian Medical Association Journal, Chinese Medical Journal, Deutsches Ärzteblatt (German Medical Journal), Ethiopian Journal of Health Sciences, JAMA (Journal of the American Medical Association), Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal), New England Journal of Medicine (NEJM), New Zealand Medical Journal, PLOS Medicine, Revista Médica de Chile, The Lancet, Ugeskrift for Laeger (Danish Medical Journal), the US National Library of Medicine, and the World Association of Medical Editors.2

The premise of this proposal is that the editors believe there is an ethical responsibility—indeed, ‘obligation’—to share clinical trial data because trial participants in a tangible way have been placed in potential harm's way. The ICMJE defines a clinical trial as ‘any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome’.3 This definition is clearly inclusive of neurointerventional (NI) trials.

The proposal

Going forward, the ICJME editors propose that investigators would be required to share de-identified individual patient data underlying the results presented in an article published in a member journal. This …

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