Compliance of clinical trial registries with the World Health Organization minimum data set : a survey
Date
2009-07
Authors
Moja, Lorenzo P.
Moschetti, Ivan
Nurbhai, Munira
Compagnoni, Anna
Liberati, Alessandro
Grimshaw, Jeremy M.
Chan, An-Wen
Dickersin, Kay
Krleza-Jeric, Karmela
Moher, David
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central
Abstract
Background: 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. The objective is to evaluate registries' and individual trial records' compliance with the 2006 version of the WHO minimum data set. Methods: A 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. Results: Among 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. Conclusion: While 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.
Description
The original publication is available at http://www.trialsjournal.com/content/10/1/56
Keywords
Clinical trial registries, World Health Organization
Citation
Moja, L. P. et al. 2009. Compliance of clininal trial registries with the World Health Organization minimum data set : a survey. Trials, 10(1), 56, http://dx.doi.org/10.1186/1745-6215-10-56