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Is data sharing the future of clinical trails?
  1. David Fiorella
  1. Correspondence to Dr David Fiorella, Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook University Medical Center, Stony Brook, NY 11794-8122, USA; David.Fiorella{at}sbumed.org

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The International Committee of Medical Journal Editors (ICMJE) recently collaborated to author an article entitled ‘Sharing Clinical Trial Data—A Proposal from the International Committee of Medical Journal Editors’ which was simultaneously published in several major medical journals.1

In the article the ICMJE propose that, in the near future, publishers will mandate that researchers share de-identified patient level data (IPD) for all clinical trials published in their journals. Clinical trials are defined as ‘any research that prospectively assigns people or a group of people to an intervention, with or without a concurrent control group, to study the cause-and-effect relationship between a health-related intervention and a health outcome’.1 At the time of trial registration a plan for this data sharing must be pre-specified. The ICMJE argues from the unassailable position that their plan ‘… will help to fulfill a moral obligation to study participants …’ and believe ‘it will benefit patients, investigators, sponsors, and society’.1

Clinical researchers would have no recourse against such a policy since they are obligated to publish results in peer-reviewed journals. So, before enthusiastically moving ahead and accepting such a drastic and consequential policy change, we should examine the context and implications of this recommendation more closely.

Anyone who has searched PubMed for an article is intimately familiar with the scenario in which his or her academic library lacks a subscription to a journal from which a critical article is needed. The purchase price for viewing a single article is typically of the order of US$30–50. While this is an occasional annoyance to the academician, this charge creates a very real access barrier to the entire non-academic community and, in particular, to patients. If …

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