Abstract
BackgroundSince September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication. The objective is to evaluate registries' and individual trial records' compliance with the 2006 version of the WHO minimum data set.MethodsA retrospective evaluation of 21 online clinical trial registries (international, national, specialty, pharmaceutical industry and local) from April 2005 to February 2007 and a cross-sectional evaluation of a stratified random sample of 610 trial records from the 21 registries.ResultsAmong 11 registries that provided guidelines for registration, the median compliance with the WHO criteria were 14 out of 20 items (range 6 to 20). In the period April 2005–February 2007, six registries increased their compliance by six data items, on average. None of the local registry websites published guidelines on the trial data items required for registration. Slightly more than half (330/610; 54.1%, 95% CI 50.1% – 58.1%) of trial records completed the contact details criteria while 29.7% (181/610, 95% CI 26.1% – 33.5%) completed the key clinical and methodological data fields.ConclusionWhile the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications.
Highlights
Since September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication
Two international (ClinicalTrials.gov and ISRCTN) and one national registry (ACTR) modified their content submission fields to become fully compliant with WHO standards during our data collection period
Implications for systematic reviewers As part of their broad search to identify potentially eligible data systematic reviewers should include trial registries for ongoing trials, in situations where there is great uncertainty about the efficacy of an intervention and it is possible that new trial data may influence the summary judgment of the review
Summary
Since September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication. Registering clinical trials is a topical issue for the health research community.[1] More than 30 years ago, the first trials registry was initiated as a way to keep track of all trials initiated and to make possible retrieval of information about unpublished trials.[2] In the interim, several trials registries have emerged, for many different purposes, including recruiting patients to trials.[3]. To those performing systematic reviews, trials registries provide an essential tool to assess completeness of the information about all initiated trials addressing a given research question, regardless of a trial's ultimate publication status. Coordinated efforts to assure global trial registration have lagged until recently, when a series of events caught the attention of the broader medical community
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