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Record W4200000996 · doi:10.1161/jaha.121.024033

Cardiovascular Safety Assessment in Cancer Drug Development

2021· article· en· W4200000996 on OpenAlexfundno aff

Bibliographic record

VenueJournal of the American Heart Association · 2021
Typearticle
Languageen
FieldMedicine
TopicChemotherapy-induced cardiotoxicity and mitigation
Canadian institutionsnot available
FundersDaiichi Sankyo EuropeIronwood Pharmaceuticals, IncorporatedNational Institute of Allergy and Infectious DiseasesHLS TherapeuticsDuke Clinical Research InstituteEisaiBelvoir Media GroupMyoKardiaNovo NordiskMedicines CompanyAstraZenecaAmarin CorporationSt. Jude MedicalRegeneron PharmaceuticalsBoston Scientific CorporationCleveland ClinicBristol-Myers SquibbEli Lilly and CompanyCSL BehringIdorsia PharmaceuticalsSanofiAmgenNational Heart, Lung, and Blood InstitutePfizer
KeywordsCardiotoxicityDrug developmentClinical trialDrugCancerHematologyRisk assessmentCardiovascular eventEndpoint DeterminationCardiac toxicity

Abstract

fetched live from OpenAlex

The development of cardiovascular toxicity attributable to anticancer drugs is a pivotal event that is associated with cardiovascular morbidity as well as with worse cancer-specific and overall outcomes. Although broad consensus exists regarding the importance of cardiovascular safety assessment in cancer drug development, real-world data suggest that cardiovascular events are significantly underestimated in oncology trials. This drug safety discrepancy has profound implications on drug development decisions, risk-benefit evaluation, formulation of surveillance and prevention protocols, and survivorship. In this article, we review the contemporary cardiovascular safety evaluation of new pharmaceuticals in hematology and oncology, spanning from in vitro pharmacodynamic testing to randomized clinical trials. We argue that cardiovascular safety assessment of anticancer drugs should be reformed and propose practical strategies, including development and validation of preclinical assays, expansion of oncology trial eligibility, incorporation of cardiovascular end points in early-phase studies, and design of longitudinal multi-institutional cardiotoxicity registries.

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)0.111
metaresearch head score (Gemma)0.125
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.111
Threshold uncertainty score0.586

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.1110.125
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0020.001
Bibliometrics0.0030.002
Science and technology studies0.0010.003
Scholarly communication0.0050.002
Open science0.0020.003
Research integrity0.0030.004
Insufficient payload (model declined to judge)0.0020.001

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 head0.013
GPT teacher head0.298
Teacher spread0.285 · 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 designTheoretical or conceptual
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

Citations12
Published2021
Admission routes1
Has abstractyes

Explore more

Same venueJournal of the American Heart AssociationSame topicChemotherapy-induced cardiotoxicity and mitigationFrench-language works237,207