Evidence map›Paper›PMID 41423856›Full record

ArticleClinical and translational science2025

Reassessing the Conduct of Patch Clamp Cardiac Ion Channel Assays to Improve Nonclinical Data Translation to Clinical ECG Changes and Proarrythmia Risk.

Claudia Alvarez Baron, Jun Zhao, Donglin Guo, Sabyasachy Mistry, Ryan De Palma, Omnia A Ismaiel, Wendy W Wu

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Claudia Alvarez BaronDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-4352-6603
Jun ZhaoDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-3663-1595
Donglin GuoDivision of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0009-0005-6888-8426
Sabyasachy MistryDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-0391-9197
Ryan De PalmaDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0001-7460-5676
Omnia A IsmaielDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-3680-621X
Wendy W WuDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0002-5055-4840

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative proposes integrating multi-cardiac ion channel pharmacology to improve the prediction of drug-induced Torsade de Pointes (TdP) risk. However, several studies under CiPA have demonstrated misalignment between nonclinical and clinical data. One study showed ECG changes induced by chloroquine, lopinavir, and ritonavir suggestive of Ca

Indexed as

ElectrocardiographyIon ChannelsTorsades de PointesCalcium Channels, L-TypeHumansMyocytes, CardiacNAV1.5 Voltage-Gated Sodium ChannelPatch-Clamp TechniquesRisk AssessmentCalcium Channels, L-TypeIon ChannelsNAV1.5 Voltage-Gated Sodium ChannelSCN5A protein, humancardiac safetyCaV1.2CiPAhERG assayNaV1.5QTC prolongationsafety marginTorsade de Pointes

Identifiers

PMID41423856
PMCPMC12719398

What OpenQuestion holds

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Registered trials

None linked

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.