Accessing and updating clinical trials – now less of a trial than before
30 Nov 2011
Trials journal has introduced an innovative new way for investigators to ensure that their clinical trials can be updated with important amendments to study protocols or new research findings. Published by open access leaders BioMed Central, 'Update' articles will give researchers the ability to rapidly publish revisions, and further findings to their original papers, thus ensuring a complete and ongoing scientific record.
The first of these new Update articles has been published in Trials for IST3 (3rd International Stoke Trial), which includes more than 3,000 patients with acute stroke. Outlining baseline characteristics of patients recruited to the trial and detailing changes to the study protocol the Update provides readers with the latest information on this 12-year large scale clinical trial, which previously had no appropriate publication format in the peer-reviewed literature. Rather than being published as an entirely new body of research or protocol, the IST3 update is directly linked to the original study and protocol, published in 2008, and is a prelude to the availability of the final results in 2012. This 'threaded' approach to publication represents an evolution in the way scholarly output and particularly clinical trials can be reported, and a fundamental shift towards researchers and clinicians being able to quickly and easily find and access all articles and data related to a particular treatment.
There are a considerable number of challenges involved in openly sharing clinical research data and BioMed Central and its journals, like Trials and BMC Research Notes, have been championing the many benefits of completing the scientific record with all scientifically sound research results and data for some time. Speaking of the launch of Updates, Journal Publisher Iain Hrynaszkiewicz said:
"Our authors would like to rapidly communicate formal, citable, peer-reviewed updates to clinical research and study protocols, which are not appropriate for corrections/errata, without needing to re-publish large amounts redundant information. Updates have been designed so that they could equally apply to any piece of completed research or a study protocol for an ongoing study, and reduced article processing-charges are available for them. We’re delighted that IST3, a large major trial that has shown great transparency in how it being reported since its inception, has published the first of these updates."
Furthermore, Peter Sandercock, co-chief investigator of the IST3 trial, University of Edinburgh added:
"IST-3 is the largest ever randomised trial of intravenous thrombolysis for stroke and will provide valuable new information on the effects of this treatment, chiefly among those excluded from treatment by the current restrictive criteria of the EU approval (notably the elderly). This new publication format has been very helpful and has enabled us to outline the steps taken to complete the trial in the face of an ever changing regulatory environment."
Head of Communications, BioMed Central
Tel: +44 (0) 20 3192 2216
Notes to Editors
1. Sandercock et al.: Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited.
Please name the journal in any story you write. If you are writing for the web, please link to the article. All articles are available free of charge, according to BioMed Central's open access policy.
2. BioMed Central is an STM (Science, Technology and Medicine) publisher which has pioneered the open access publishing model. All peer-reviewed research articles published by BioMed Central are made immediately and freely accessible online, and are licensed to allow redistribution and reuse. BioMed Central is part of Springer Science+Business Media, a leading global publisher in the STM sector.
3. Trials is an open access, peer-reviewed, online journal that encompasses all aspects of the performance and findings of randomized controlled trials. We publish articles on general trial methodology as well as protocols, commentaries and traditional results papers - regardless of outcome or significance of findings.
4. Current Controlled Trials allows users to search, register and share information about randomised controlled trials. Access to all the information on this site is free; charges for the registration services offered by Current Controlled Trials are available on request. Publication services are also available via the range of open access peer-reviewed journals published by our sister company, BioMed Central.