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21 March 2013 
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Current Controlled Trials Newsletter
Current Controlled Trials

Newsletter

March 2013

Digital object identifiers (DOIs) for ISRCTN records

 
Cross Reg
DOIs are widely used by academic publishers for helping to ensure the permanence, discoverability and citability of scholarly content published on the web. A trial ID such as the ISRCTN uniquely identifies a piece of research while a DOI ensures that the web link to the trial ID can persistently be discovered and cited. We have implemented DOIs for all ISRCTN trial records. More than 11,000 records will now display a DOI and can be cited in reference lists, which is required by BioMed Central journals. The introduction of this feature will further enable trial registration with an ISRCTN to be the first step in disseminating all publications and outcomes of clinical trials in a linked and easily-discoverable ("threaded") fashion.
 
 

UK Clinical Trials Gateway (UKCTG)

 
UKCTG Logo
The results of the UK Clinical Trials Gateway (UKCTG) Patient and Public Survey have now been published by the National Institute for Health Research (NIHR). The aim of the survey was to find out how effective the UKCTG website is for people to access information on clinical trials and to use this feedback to provide an improved service in the future. Simon Denegri, NIHR National Director for Public Participation and Engagement in Research has provided his vision and strategy for the UKCTG in his blog 'Public have their say on clinical trials gateway'.

The ISRCTN clinical trial data are pooled into the UKCTG. The introduction of the lay summary field to all ISRCTN trial records in 2011 is providing information on clinical trials, in plain language, to a wider audience. Today over 1,000 ISRCTN trial records include user friendly information.
 
 

SPIRIT 2013 statement

 
Trials
The protocol of a clinical trial plays a key role in study planning, conduct, interpretation, oversight, and external review by detailing the plans from ethics approval to dissemination of results. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement, a 33-item checklist, has been published with the aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other stakeholders. The journal Trials is amongst the first endorsers of the SPIRIT statement and is dedicated to publishing protocols, results and other issues relevant to clinical trials. To submit an update, registered protocol, or trial result visit the Trials website.
 
 

When to register clinical trials?

 
ISRCTN
The International Committee of Medical Journal Editors (ICMJE) recommends prospective registration of clinical trials. A recent article published in JAMIA concludes that five journals selected for study, adhered well to mandatory and timely trial registration policies. The ISRCTN register accepts retrospective registration of trials because an inclusion in a database such as the ISRCTN register is considered a better option than no inclusion at all. In recent years, the ISRCTN register has seen a change in the trend. A decade ago; only 16% of the trials were registered prospectively, while in 2012 this rose to 52%. We would like to encourage trialists to register trials prospectively and help promote transparency in clinical research.
 
 

All Trials Campaign

 
+ All Trials
The All Trials Campaign launched in January 2013 calls on responsible bodies to ensure that all trials past and present, for all treatments, are registered; and that the full methods and the results are reported to improve openness of clinical research. A public petition is now open to sign; BioMed Central supports this initiative and has signed the petition.
 
 

WHO International Clinical Trials Registry Platform (WHO ICTRP)

 
The ISRCTN register provided consultation to the WHO ICTRP to define the specific and detailed standards for the International Standards for Clinical Trial Registries which were published recently. The ISRCTN register is a data provider to the WHO ICTRP and complies with the WHO 20-item Trial Registration Data Set.
 
 
 
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