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Record W2973773439 · doi:10.1136/bmj.l5619

Half of trials supporting new cancer drug approval in Europe had high risk of bias

2019· article· en· W2973773439 on OpenAlexaboutno aff
Elisabeth Mahase

Bibliographic record

VenueBMJ · 2019
Typearticle
Languageen
FieldEconomics, Econometrics and Finance
TopicHealth Systems, Economic Evaluations, Quality of Life
Canadian institutionsnot available
Fundersnot available
KeywordsCancer drugsMedicineClinical trialDrug approvalDrugCancerDrug trialFamily medicineIntensive care medicinePharmacologyInternal medicine

Abstract

fetched live from OpenAlex

Researchers have called for tougher regulations on approving cancer drugs in Europe after they found that many drugs were licensed on the basis of poorly designed trials that included no data on whether the drugs helped patients to live longer. Around half of the trials that supported new cancer drug approvals in Europe from 2014 to 2016 were judged to have a high risk of bias, indicating that the treatment effects might have been exaggerated, the team found in a study published by The BMJ .1 Researchers from the UK, the US, and Canada assessed the randomised controlled trials (RCTs) that were used to support the approval of new cancer drugs by the …

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)0.436
metaresearch head score (Gemma)0.698
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.564
Threshold uncertainty score0.696

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.4360.698
Meta-epidemiology (narrow)0.0010.002
Meta-epidemiology (broad)0.0060.009
Bibliometrics0.0060.008
Science and technology studies0.0010.005
Scholarly communication0.0080.010
Open science0.0020.005
Research integrity0.0070.005
Insufficient payload (model declined to judge)0.0110.002

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 head0.489
GPT teacher head0.482
Teacher spread0.007 · 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 designObservational
DomainMethods
GenreEmpirical

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
Published2019
Admission routes1
Has abstractyes

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