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Record W2106330956 · doi:10.1186/1745-6215-10-56

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

2009· article· en· W2106330956 on OpenAlex
Lorenzo Moja, Ivan Moschetti, M. Nurbhai, Anna Compagnoni, Alessandro Liberati, Jeremy Grimshaw, An‐Wen Chan, Kay Dickersin, Karmela Krleža-Jerić, David Moher, Ida Sim, Jimmy Volmink

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.
fundA Canadian funder is recorded on the work.

Bibliographic record

VenueTrials · 2009
Typearticle
Languageen
FieldDecision Sciences
TopicMeta-analysis and systematic reviews
Canadian institutionsChildren's Hospital of Eastern OntarioCanadian Institutes of Health ResearchUniversity of OttawaUniversity of TorontoInstitute of Population and Public Health
FundersUniversity of Ottawa
KeywordsMedicineClinical trialMinimum Data SetSpecialtyFamily medicineData qualityMedical recordQuality assuranceTrial registrationMEDLINENursingSurgery

Abstract

fetched live from OpenAlex

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.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.600
metaresearch head score (Gemma)0.392
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Insufficient payload (model declined to judge)
Consensus categoriesMetaresearch
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.456
Threshold uncertainty score0.999

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.6000.392
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0070.000
Bibliometrics0.0000.003
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0030.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0020.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.981
GPT teacher head0.710
Teacher spread0.271 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it