Evidence map›Paper›PMID 31600125›Full record

ReviewCirculation research2019

Workshop Report: FDA Workshop on Improving Cardiotoxicity Assessment With Human-Relevant Platforms.

Li Pang, Philip Sager, Xi Yang, Hong Shi, Frederick Sannajust, Mathew Brock, Joseph C Wu, Najah Abi-Gerges, Beverly Lyn-Cook, Brian R Berridge and 1 more

Abstract readReview
In one paragraph

Review in Circulation research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
–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

45 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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 · 2026
    Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Chemical-induced heart defects using a transgenic zebrafish model.Toxicological sciences : an official journal of the Society of Toxicology · 2025
    Article
  8. Cardiac Channelopathies: Clinical Diagnosis and Promising Therapeutics.Journal of the American Heart Association · 2025
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
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

11 authors.

Li PangFrom the Division of Systems Biology, National Center for Toxicological Research, U.S. Food and Drug Administration (L.P.).
Philip SagerStanford University School of Medicine (P.S.).
Xi YangDivision of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (X.Y.).
Hong ShiDiscovery Toxicology, Bristol-Myers Squibb (BMS) Company (H.S.).
Frederick SannajustSafety & Exploratory Pharmacology Department, SALAR Division, Merck & Co (F.S.).
Mathew BrockInvestigative Toxicology, Genentech Inc (M.B.).
Joseph C WuStanford University School of Medicine, Stanford Cardiovascular Institute (J.C.W.).
Najah Abi-GergesAnaBios Corporation (N.A.-G.).
Beverly Lyn-CookDivision of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration (B.L.-C.).
Brian R BerridgeDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health (B.R.B.).
Norman StockbridgeDivision of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (N.S.).

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Given that cardiovascular safety concerns remain the leading cause of drug attrition at the preclinical drug development stage, the National Center for Toxicological Research of the US Food and Drug Administration hosted a workshop to discuss current gaps and challenges in translating preclinical cardiovascular safety data to humans. This white paper summarizes the topics presented by speakers from academia, industry, and government intended to address the theme of improving cardiotoxicity assessment in drug development. The main conclusion is that to reduce cardiovascular safety liabilities of new therapeutic agents, there is an urgent need to integrate human-relevant platforms/approaches into drug development. Potential regulatory applications of human-derived cardiomyocytes and future directions in employing human-relevant platforms to fill the gaps and overcome barriers and challenges in preclinical cardiovascular safety assessment were discussed. This paper is intended to serve as an initial step in a public-private collaborative development program for human-relevant cardiotoxicity tools, particularly for cardiotoxicities characterized by contractile dysfunction or structural injury.

Indexed as

AnimalsCardiotoxicityCardiotoxinsDrug Evaluation, PreclinicalEducationHumansInduced Pluripotent Stem CellsMyocytes, CardiacResearch ReportUnited StatesUnited States Food and Drug AdministrationCardiotoxinscardiotoxicitydrug developmenthumansrisk assessmentstem cells

Identifiers

PMID31600125
PMCPMC6788760

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.