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Record W4405231044 · doi:10.1016/j.jaccao.2024.09.014

Cardiovascular Safety in Oncology Clinical Trials

2024· review· fi· W4405231044 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

VenueJACC CardioOncology · 2024
Typereview
Languagefi
FieldMedicine
TopicChemotherapy-induced cardiotoxicity and mitigation
Canadian institutionsHealth Canada
FundersAstellas PharmaAstraZenecaPfizer
KeywordsMedicineClinical trialInternal medicineClinical OncologyIntensive care medicineOncologyMedical physicsCancer

Abstract

fetched live from OpenAlex

The development of novel treatments has improved cancer outcomes but may result in cardiovascular toxicities. Traditional approaches to clinical trial safety evaluation have limitations in their ability to detect signals of cardiovascular risk. Mechanisms to increase power and specificity to clarify cardiovascular safety are required. However, implications include increased costs and slower development. The Cardiovascular Safety Research Consortium facilitated stakeholder discussions with representation from academia, industry, and regulators. A think tank was assembled with the aim of providing recommendations for improved collection and reporting of cardiovascular safety signals in oncology trials. Two working groups were formed. The first focuses on incorporation of consensus definitions of cardiovascular disease into the Common Terminology Criteria for Adverse Events used in oncology trial reporting. The second group considers methods for ascertainment and adjudication of cardiovascular events in cancer trials. The overarching aim of this primer is to improve understanding of the potential cardiovascular toxicities of cancer therapies. • Improved cardiovascular event definitions should be used in cancer therapy trials. • Refinements in safety data ascertainment methods should allow better characterization of potential treatment-associated toxicities. • Optimal cardiovascular event ascertainment and recording methods may vary depending on drug, development stage, and patient factors.

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)0.077
metaresearch head score (Gemma)0.011
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (narrow), Meta-epidemiology (broad), Research integrity, Insufficient payload (model declined to judge)
Consensus categoriesMetaresearch, Meta-epidemiology (narrow), Meta-epidemiology (broad), Research integrity
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.940
Threshold uncertainty score0.999

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0770.011
Meta-epidemiology (narrow)0.0020.002
Meta-epidemiology (broad)0.0320.027
Bibliometrics0.0020.002
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0010.001
Research integrity0.0100.008
Insufficient payload (model declined to judge)0.0010.004

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 head0.296
GPT teacher head0.519
Teacher spread0.223 · 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