ReviewClinical pharmacology and therapeutics2018
Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the "CiPA" Initiative and Design of a Prospective Clinical Validation Study.
Review in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03070470 (Comprehensive in Vitro Proarrhythmia Assay), which is not on this map. Cited by 66 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comprehensive in Vitro Proarrhythmia Assay (CiPA) Clinical Phase 1 ECG Biomarker Validation Study (CiPA Phase 1 ECG Biomarker Study)
Who cites it
66 citing papers in PubMed, 129 citations in OpenAlex.
- Assessment of Multi-Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study.Clinical pharmacology and therapeutics · 2019Trial
- T vector velocity: A new ECG biomarker for identifying drug effects on cardiac ventricular repolarization.PloS one · 2019Trial
- Application of an Open-Source Modular Framework for Pharmacokinetic, Pharmacodynamic, and Safety Simulations to Anti-Tuberculosis Drugs.CPT: pharmacometrics & systems pharmacology · 2026Article
- Review of in vitro approaches for assessing the toxicity of chemical stressors across diverse physiological systems.Toxicological sciences : an official journal of the Society of Toxicology · 2026Review
- Improving In Silico Cardiac Safety Prediction by Consensus Averaging of Transmural Ventricular Cell Models.Annals of biomedical engineering · 2026Article
- Predictive Safety in the Era of Artificial Intelligence: Promises, Limits, and the Case for an Enterprise Lifecycle Evidence Ecosystem.Drug safety · 2026Review
- Cardiosim-Tox: an interpretable multitask deep learning QSAR platform with multimodal feature fusion for predicting hERG, Cav1.2, and Nav1.5 blockade risk and potency.Archives of toxicology · 2026Article
- Motif-Level Graph Learning Enables Interpretable Prediction of Drug-Induced QT Prolongation via Cooperative Substructural Determinants.International journal of molecular sciences · 2026Article
- A Deep Learning-Based Scoring Framework for Large-Scale Multi-Donor Cardiotoxicity Screening.bioRxiv : the preprint server for biology · 2026Article
- Models of the human heart for biomedical research: Opportunities and challenges.Physiological reports · 2026Review
- A multiscale computational model of cardiac electrophysiology for drug-induced pro-arrhythmic risk stratification.Biomedical engineering letters · 2026Article
- A Deep-Learning-Based Scoring Framework for Large-Scale Multi-donor Cardiotoxicity Screening.Computational and structural biotechnology journal · 2026Article
- Synergistic antiarrhythmic mechanism of IJournal of translational medicine · 2025Article
- Validation of new AI-based classification method for in silico cardiac safety assessment of drugs following the CiPA framework.Archives of toxicology · 2025Article
- Transgender-Affirming Hormone Therapies, QT Prolongation, and Cardiac Repolarization.JAMA network open · 2025Article
- A high-performance extracellular field potential analyzer for iPSC-derived cardiomyocytes.Scientific reports · 2025Article
- Harnessing large language models' zero-shot and few-shot learning capabilities for regulatory research.Briefings in bioinformatics · 2024Article
- Article
- Circadian regulation of sinoatrial nodal cell pacemaking function: Dissecting the roles of autonomic control, body temperature, and local circadian rhythmicity.PLoS computational biology · 2024Article
- Neural network emulation of the human ventricular cardiomyocyte action potential: a tool for more efficient computation in pharmacological studies.bioRxiv : the preprint server for biology · 2023Article
6 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative is developing and validating a mechanistic-based assessment of the proarrhythmic risk of drugs. CiPA proposes to assess a drug's effect on multiple ion channels and integrate the effects in a computer model of the human cardiomyocyte to predict proarrhythmic risk. Unanticipated or missed effects will be assessed with human stem cell-derived cardiomyocytes and electrocardiogram (ECG) analysis in early phase I clinical trials. This article provides an overview of CiPA and the rationale and design of the CiPA phase I ECG validation clinical trial, which involves assessing an additional ECG biomarker (J-Tpeak) for QT prolonging drugs. If successful, CiPA will 1) create a pathway for drugs with hERG block / QT prolongation to advance without intensive ECG monitoring in phase III trials if they have low proarrhythmic risk; and 2) enable updating drug labels to be more informative about proarrhythmic risk, not just QT prolongation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.