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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Compliance of clinical trial registries with the World Health Organization minimum data set: A survey
Trials, Volume 10, Article 56, Year 2009
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Description
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. © 2009 Moja et al; licensee BioMed Central Ltd.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2734552/bin/1745-6215-10-56-S1.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2734552/bin/1745-6215-10-56-S2.doc
Authors & Co-Authors
Moja, Lorenzo P.
Italy, Milan
Istituto Di Ricerche Farmacologiche Mario Negri
Moschetti, Ivan
Italy, Milan
Istituto Di Ricerche Farmacologiche Mario Negri
Nurbhai, Munira
Canada, Ottawa
Ottawa Hospital Research Institute
Compagnoni, Anna
Italy, Milan
Istituto Di Ricerche Farmacologiche Mario Negri
Liberati, Alessandro
Italy, Milan
Istituto Di Ricerche Farmacologiche Mario Negri
Italy, Modena
Università Degli Studi Di Modena e Reggio Emilia
Grimshaw, Jeremy M.
Canada, Ottawa
Ottawa Hospital Research Institute
Canada, Ottawa
University of Ottawa
Chan, Anwen
Canada, Toronto
University of Toronto
Canada, Ottawa
Canadian Institutes of Health Research
Dickersin, Kay
United States, Baltimore
Johns Hopkins Bloomberg School of Public Health
Krleža-Jerić, Karmela
Canada, Ottawa
Canadian Institutes of Health Research
Moher, David
Canada, Ottawa
Children's Hospital of Eastern Ontario, Ottawa
Sim, Ida
United States, San Francisco
Ucsf School of Medicine
Switzerland, Geneva
Organisation Mondiale de la Santé
Volmink, Jimmy A.
South Africa, Cape Town
Stellenbosch University, Faculty of Medicine and Health Sciences
Statistics
Citations: 61
Authors: 12
Affiliations: 11
Identifiers
Doi:
10.1186/1745-6215-10-56
ISSN:
17456215
e-ISSN:
17456215
Study Design
Cross Sectional Study
Cohort Study
Study Approach
Quantitative