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Record W1993607274 · doi:10.1002/sim.1297

The European regulatory experience

2002· article· en· W1993607274 on OpenAlex

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.

Bibliographic record

VenueStatistics in Medicine · 2002
Typearticle
Languageen
FieldMathematics
TopicStatistical Methods in Clinical Trials
Canadian institutionsHatch (Canada)
Fundersnot available
KeywordsClinical trialRegulatory scienceMargin (machine learning)Risk analysis (engineering)Work (physics)MedicineComputer scienceManagement scienceEconomics

Abstract

fetched live from OpenAlex

This paper discusses four methodological topics that have been a regular source of difficulty and debate in European regulatory work. (i) The increasing use of non-inferiority trials in the development of medicinal products has highlighted several problems. These relate first to the choice of the non-inferiority margin and secondly to the circumstances under which a non-inferiority design is or is not appropriate. (ii) The use of meta-analysis in regulatory applications is still controversial and acceptable uses need to be defined. (iii) Analysis of responders provides a useful insight into the size of treatment benefits but can be misleading, especially when it is impossible to be certain whether or not an individual patient has truly responded to treatment. (iv) The extent of the monitoring of clinical trial procedures and data still distinguishes industry-sponsored trials from other trials: it is not clear that it should. These questions are all equally important for those involved in clinical trial work outside the arena of pharmaceutical development.

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)0.006
metaresearch head score (Gemma)0.184
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: Theoretical or conceptual
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.252
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0060.184
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0010.000

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 head0.530
GPT teacher head0.563
Teacher spread0.034 · 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