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Record W1970618445 · doi:10.1002/bimj.200410081

Superior Safety in Noninferiority Trials

2005· article· en· W1970618445 on OpenAlexaff
David R. Bristol

Bibliographic record

VenueBiometrical Journal · 2005
Typearticle
Languageen
FieldMathematics
TopicStatistical Methods in Clinical Trials
Canadian institutionsPurdue Pharma (Canada)
Fundersnot available
KeywordsMedicineComputer science

Abstract

fetched live from OpenAlex

Noninferiority of a new treatment to a reference treatment with respect to efficacy is usually associated with the superiority of the new treatment to the reference treatment with respect to other aspects not associated with efficacy. When the superiority of the new treatment to the reference treatment is with respect to a specified safety variable, it may be necessary to perform the between-treatment comparisons. The efficacy and safety comparisons may be considered separately or simultaneous comparisons may be performed. Here techniques are discussed for the simultaneous consideration of both aspects.

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)0.528
metaresearch head score (Gemma)0.695
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: Methods
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.472
Threshold uncertainty score0.583

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.5280.695
Meta-epidemiology (narrow)0.0020.002
Meta-epidemiology (broad)0.0080.009
Bibliometrics0.0040.005
Science and technology studies0.0010.007
Scholarly communication0.0040.010
Open science0.0030.006
Research integrity0.0070.010
Insufficient payload (model declined to judge)0.0120.002

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 head0.745
GPT teacher head0.629
Teacher spread0.115 · 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 designTheoretical or conceptual
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

Citations8
Published2005
Admission routes1
Has abstractyes

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