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Record W4238575527 · doi:10.1177/2168479019838827

Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice

2019· article· en· W4238575527 on OpenAlexaff
Bohdana Ratitch, James Bell, Craig Mallinckrodt, Jonathan W. Bartlett, Niti Goel, Geert Molenberghs, Michael O’Kelly, Pritibha Singh, Ilya Lipkovich

Bibliographic record

VenueTherapeutic Innovation & Regulatory Science · 2019
Typearticle
Languageen
FieldEconomics, Econometrics and Finance
TopicHealth Systems, Economic Evaluations, Quality of Life
Canadian institutionsEli Lilly (Canada)
Fundersnot available
KeywordsPharmacyClinical trialMedicineClinical PracticeMedical educationMedical physicsFamily medicinePsychologyInternal medicine

Abstract

fetched live from OpenAlex
No abstract in any covered source. Its absence is recorded, not treated as a negative.

No abstract. This is not a gap in this database; OpenAlex has none either. 23.3% of the frame is in this state, and the screen finds HALF as much metaresearch here, so the absence is a measured bias rather than a missing field.

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)0.500
metaresearch head score (Gemma)0.806
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 score0.500
Threshold uncertainty score0.617

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.5000.806
Meta-epidemiology (narrow)0.0030.004
Meta-epidemiology (broad)0.0140.006
Bibliometrics0.0060.005
Science and technology studies0.0020.014
Scholarly communication0.0100.013
Open science0.0060.010
Research integrity0.0160.025
Insufficient payload (model declined to judge)0.0100.002

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 head0.600
GPT teacher head0.575
Teacher spread0.025 · 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

Citations10
Published2019
Admission routes1
Has abstractno

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