Trials publishes the International Stroke Trial data set

《华尔街日报》Trialshas, since its launch, aimed to be a force for change in publishing – experimenting with and refining novel approaches to reporting information about randomised controlled trials. Thesharing and publishing of clinical research dataunderlying trials has been an area of the journal’s focus, and the editors have sought toestablish guidelinesfor this emerging area of journal publishing. Anarticlejust-published in the journal puts clinical data sharing – from one of the largest clinical trials in acute stroke ever conducted – firmly into practice.

The results of the firstInternational Stroke Trial(IST) suggested that aspirin should be administered to stroke patients as soon as possible after the onset of ischaemic stroke. The original report of the trial was published in 1997 inThe Lancet. The primary purpose of this latest article by Sandercocket al. is to publish the individual patient data from the IST trial; the data set includes data on 19,435 patients with acute stroke, with 99% complete follow-up.

The authors should be commended for their efforts to make data available to facilitate planning of future trials and enable secondary analyses. The background care patients received in the nineties, when stroke unit care was not widely available, means the trial is representative of stroke trials currently ongoing in resource poor settings and the data may be particularly helpful for planning trials in developing countries – which face a future epidemic of non-communicable diseases.

With transparency in research and data comes responsibility, and the authors have explicitly addressed the issue of patient privacy. They provide a statement on consent for data sharing and anonymity, in accordance with best-practice guidelines on preparing clinical data for publication, which were co-publishedinTrialsandtheBMJlast year.

The latest IST trial,IST-3, is currently ongoing – recruiting patients until 30th June 2011. Theprotocol for IST-3was published inTrials在2008年。尽管国际年代troke Trial database’ was not commissioned by the journal, it will be added toTrials‘ series onSharing clinical research data, edited by Andrew Vickers.

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