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International Committee of Medical Journal Editors' Definition of a Clinical Trial

2005· article· en· W1966829029 on OpenAlexaboutno aff
Christine Lainé

Bibliographic record

VenueAnnals of Internal Medicine · 2005
Typearticle
Languageen
FieldDecision Sciences
TopicMeta-analysis and systematic reviews
Canadian institutionsnot available
Fundersnot available
KeywordsClinical trialMedicineMedical journalDirectiveStatement (logic)Family medicineAlternative medicineLibrary sciencePolitical scienceLawInternal medicinePathology

Abstract

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Letters6 December 2005International Committee of Medical Journal Editors' Definition of a Clinical TrialChristine Laine, MD, MPH, Senior Deputy EditorChristine Laine, MD, MPH, Senior Deputy EditorSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-143-11-200512060-00024 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:The editors of Annals of Internal Medicine wholeheartedly agree with Dr. Campillo-Artero's statements about the supremacy of randomized, controlled trials over trials that do not use random assignment. However, because the goal of the ICMJE policy on trials registration was to promote accessibility to clinically directive experimental research, the committee adopted a broad definition of clinical trials (1). Of note, the Ottawa Group, working closely with the World Health Organization to promote comprehensive trials registration, defines trials in an even broader manner than does the ICMJE. According to the Ottawa Group (2), trial refers to “a prospective controlled ...References1. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [Editorial]. Ann Intern Med. 2004;141:477-8. [PMID: 15355883] LinkGoogle Scholar2. Krleza-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ. 2005;330:956-8. [PMID: 15845980] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Christine Laine, MD, MPH, Senior Deputy EditorDisclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoClinical Trial Registration: A Statement from the International Committee of Medical Journal Editors Catherine De Angelis , Jeffrey M. Drazen , Frank A. Frizelle , Charlotte Haug , John Hoey , Richard Horton , Sheldon Kotzin , Christine Laine , Ana Marusic , A. John P.M. Overbeke , Torben V. Schroeder , Harold C. Sox , and Martin B. Van Der Weyden Is This Clinical Trial Fully Registered? Catherine D. De Angelis , Jeffrey M. Drazen , Prof Frank A. Frizelle , Charlotte Haug , John Hoey , Richard Horton , Sheldon Kotzin , Christine Laine , Ana Marusic , A. John P.M. Overbeke , Torben V. Schroeder , Harold C. Sox , and Martin B. Van Der Weyden International Committee of Medical Journal Editors' Definition of a Clinical Trial Carlos Campillo-Artero Metrics 6 December 2005Volume 143, Issue 11Page: 847KeywordsClinical trialsConflicts of interestGlobal healthHealth information technology ePublished: 6 December 2005 Issue Published: 6 December 2005 Copyright & PermissionsCopyright © 2005 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

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.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.408
metaresearch head score (Gemma)0.520
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Methods · Consensus signal: none
Teacher disagreement score0.592
Threshold uncertainty score0.730

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.4080.520
Meta-epidemiology (narrow)0.0040.005
Meta-epidemiology (broad)0.0120.007
Bibliometrics0.0220.015
Science and technology studies0.0130.022
Scholarly communication0.0450.019
Open science0.0160.019
Research integrity0.0710.071
Insufficient payload (model declined to judge)0.0160.027

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 head0.853
GPT teacher head0.644
Teacher spread0.210 · 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

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designNot applicable
DomainMethods
GenreMethods

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2005
Admission routes1
Has abstractyes

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