Study finds clinical trial registrations often fail to meet WHO data standards

The WHO minimum dataset has improved trial registry compliance but many individual trial records recorded between April 2005 and February 2007 still omit key information, including researcher contact details, a study published this week in Trials has found.

The registration of clinical trials in a publicly accessible database has become an established part of the research process for healthcare interventions, and is also increasingly accepted on ethical and moral grounds. The most recent revision to the Declaration of Helsinki – in October 2008 – included a requirement for prospective trial registration.

Since 2005 the ICMJE has required that trials be registered in compliance with the 20-item WHO minimum dataset – “The minimum amount of trial information that must appear in a register in order for a given trial to be considered fully registered.”

Moja et al. performed a retrospective analysis of 21 online clinical trial registries from April 2005 to February 2007 for compliance with the WHO minimum dataset. They found that, among the 11 registries that provided guidelines for registration, the median compliance with the WHO criteria were 14 out of 20 items (range 6 to 20).


Compliance of clinical trial registries with the World Health Organization minimum data set: a survey
P Moja, Ivan Moschetti, Munira Nurbhai, Anna Compagnoni, Alessandro
Liberati, Jeremy M Grimshaw, An-Wen Chan, Kay Dickersin, Karmela
Krleza-Jeric, David Moher, Ida Sim, Jimmy Volmink
Trials 2009, 10:56 (22 July 2009)

Slightly more than half of trial records completed the contact details criteria, and none of the local registry websites studied published guidelines on the trial data items required for registration. 

As such the authors call for peer reviewers and journal editors to scrutinise trial registration records to ensure consistency with WHO’s core content requirements when considering trial-related publications.

During the course of the study, 2 international registries (including ISRCTN – administered by BioMed Central’s sister company, Current Controlled Trials) and 1 national registry modified their submission fields to become fully compliant with WHO standards. At the end of the data collection period, February 2007, ISRCTN was among the registries that enabled full 20-item compliance.

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