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Compliance of clinical trial registries with the World Health Organization minimum data set: a survey.

Moja LP, Moschetti I, Nurbhai M, Compagnoni A, Liberati A, Grimshaw JM, Chan AW, Dickersin K, Krleza-Jeric K, Moher D, Sim I, Volmink J - Trials (2009)

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Italian Cochrane Centre, Mario Negri Institute for Pharmacological Research, Milan, Italy. moja@marionegri.it

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.

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Related in: MedlinePlus

Contact details. Percentage (95% confidence interval) of trial records reporting minimum contact details (defined as the presence of name of contact person and one additional item: address, telephone, fax or e-mail) by type of registry.
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Figure 1: Contact details. Percentage (95% confidence interval) of trial records reporting minimum contact details (defined as the presence of name of contact person and one additional item: address, telephone, fax or e-mail) by type of registry.

Mentions: Table 3 lists the percentages of compliant records relative to registries. The final sample of 610 trial records covered different years (range: 1981 to 2005). However the majority of trials were recently registered (<1999 n = 77 (13% out of 610); 2004–2000 n = 246 (40% out of 610); 2005 n = 156 (26% out of 610)). In 131 records the registration date was not available. Overall, 330 trial records, 54.1% (50.1% – 58.1), completed the contact details criteria. Trial records in national registries adhered more often with this requirement (compliance 99%) while those in drug company registries never reported it (Figure 1). 181 records, 29.7% (26.1 – 33.5), provided complete information about key aspects of trial design (target condition, intervention, study type, at least one outcome and key inclusion and exclusion criteria; Figure 2). Among these five key methodological data fields compliance varied across items from 40.5% (36.6 – 44.5) for primary outcome measures to 75.2% (71.6 – 78.6) for target condition. 'Research ethics review' (6.9% (5.0% – 9.2)), 'responsible contact person' (8.2% (6.1 – 10.7)) and 'secondary outcomes' (21.6% (18.4% – 25.1)) had lower compliance rates.


Compliance of clinical trial registries with the World Health Organization minimum data set: a survey.

Moja LP, Moschetti I, Nurbhai M, Compagnoni A, Liberati A, Grimshaw JM, Chan AW, Dickersin K, Krleza-Jeric K, Moher D, Sim I, Volmink J - Trials (2009)

Contact details. Percentage (95% confidence interval) of trial records reporting minimum contact details (defined as the presence of name of contact person and one additional item: address, telephone, fax or e-mail) by type of registry.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2734552&req=5

Figure 1: Contact details. Percentage (95% confidence interval) of trial records reporting minimum contact details (defined as the presence of name of contact person and one additional item: address, telephone, fax or e-mail) by type of registry.
Mentions: Table 3 lists the percentages of compliant records relative to registries. The final sample of 610 trial records covered different years (range: 1981 to 2005). However the majority of trials were recently registered (<1999 n = 77 (13% out of 610); 2004–2000 n = 246 (40% out of 610); 2005 n = 156 (26% out of 610)). In 131 records the registration date was not available. Overall, 330 trial records, 54.1% (50.1% – 58.1), completed the contact details criteria. Trial records in national registries adhered more often with this requirement (compliance 99%) while those in drug company registries never reported it (Figure 1). 181 records, 29.7% (26.1 – 33.5), provided complete information about key aspects of trial design (target condition, intervention, study type, at least one outcome and key inclusion and exclusion criteria; Figure 2). Among these five key methodological data fields compliance varied across items from 40.5% (36.6 – 44.5) for primary outcome measures to 75.2% (71.6 – 78.6) for target condition. 'Research ethics review' (6.9% (5.0% – 9.2)), 'responsible contact person' (8.2% (6.1 – 10.7)) and 'secondary outcomes' (21.6% (18.4% – 25.1)) had lower compliance rates.

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Italian Cochrane Centre, Mario Negri Institute for Pharmacological Research, Milan, Italy. moja@marionegri.it

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.

Show MeSH
Related in: MedlinePlus