The journal Trials has, 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. The sharing and publishing of clinical research data underlying trials has been an area of the journal’s focus, and the editors have sought to establish guidelines for this emerging area of journal publishing. An article just-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 first International 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 in The Lancet. The primary purpose of this latest article by Sandercock et 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-published in Trials and the BMJ last year.
The latest IST trial, IST-3, is currently ongoing – recruiting patients until 30th June 2011. The protocol for IST-3 was published in Trials in 2008. Although ‘The International Stroke Trial database’ was not commissioned by the journal, it will be added to Trials‘ series on Sharing clinical research data, edited by Andrew Vickers.