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The Uses of Biomarkers in Drug Development

2009· article· en· W1967544971 on OpenAlexaff
Orest Hurko

Bibliographic record

VenueAnnals of the New York Academy of Sciences · 2009
Typearticle
Languageen
FieldEconomics, Econometrics and Finance
TopicHealth Systems, Economic Evaluations, Quality of Life
Canadian institutionsWomen's Health Research Institute
Fundersnot available
KeywordsBiomarkerDrug developmentMedicineSurrogate endpointClinical trialDrugDrug trialDosingEfficacyIntensive care medicineBiomarker discoveryBioinformaticsOncologyPharmacologyInternal medicineBiologyProteomics

Abstract

fetched live from OpenAlex

Although the value of "surrogate biomarkers" (strictly speaking, those biomarkers that can serve as surrogate primary endpoints in registration trials) is significant, such biomarkers are few. However, "nonsurrogate biomarkers" are increasingly being used to reduce the risks of drug development. Any given biomarker is usually useful for only one of four types of risk reduction: that associated with (1) an inappropriate dosing regimen; (2) enrollment of nonresponsive subjects into clinical trials; (3) an inability to detect an efficacy signal quickly and reliably in chronic disorders; or (4) delayed recognition of potential side effects and/or toxicity. A biomarker suitable for one purpose is usually not suitable for the other three. Although these considerations apply to all drug development, both the need and availability of appropriate biomarkers in each category vary between therapeutic areas. The focus is on diseases of the brain.

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)0.049
metaresearch head score (Gemma)0.098
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.049
Threshold uncertainty score0.261

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0490.098
Meta-epidemiology (narrow)0.0020.001
Meta-epidemiology (broad)0.0020.001
Bibliometrics0.0100.006
Science and technology studies0.0010.012
Scholarly communication0.0080.011
Open science0.0020.004
Research integrity0.0040.006
Insufficient payload (model declined to judge)0.0030.001

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 head0.487
GPT teacher head0.461
Teacher spread0.026 · 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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNot applicable
Domainnot available
GenreReview

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

Citations44
Published2009
Admission routes1
Has abstractyes

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Same venueAnnals of the New York Academy of SciencesSame topicHealth Systems, Economic Evaluations, Quality of LifeFrench-language works237,207