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Trials

, 10:56

First Online: 22 July 2009Received: 26 November 2008Accepted: 22 July 2009DOI: 10.1186-1745-6215-10-56

Cite this article as: Moja, L.P., Moschetti, I., Nurbhai, M. et al. Trials 2009 10: 56. doi:10.1186-1745-6215-10-56

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.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-10-56 contains supplementary material, which is available to authorized users.

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Autor: Lorenzo P Moja - Ivan Moschetti - Munira Nurbhai - Anna Compagnoni - Alessandro Liberati - Jeremy M Grimshaw - An-Wen Cha

Fuente: https://link.springer.com/







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