Evidence map›Paper›PMID 31314926›Full record

ReviewClinical pharmacology and therapeutics2020

Next-Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development.

Sharin E Roth, Mark I Avigan, David Bourdet, David Brott, Rachel Church, Ajit Dash, Douglas Keller, Philip Sherratt, Paul B Watkins, Lucas Westcott-Baker and 6 more

Abstract readReview
In one paragraph

Review in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 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

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Guideline
  2. [Chinese guideline for diagnosis and management of drug-induced liver injury (2023 version)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2023
    Guideline
  3. Pooled it
  4. Mechanisms of drug induced liver injury.Cellular and molecular life sciences : CMLS · 2025
    Review
  5. Article
  6. Serum glutamate dehydrogenase activity enables sensitive and specific diagnosis of hepatocellular injury in humans.Toxicological sciences : an official journal of the Society of Toxicology · 2025
    Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. 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

16 authors.

Sharin E RothOtsuka PDC, Rockville, Maryland, USA.
Mark I AviganUS Food and Drug Administration, Silver Spring, Maryland, USA.
David BourdetTheravance Biopharma, South San Francisco, California, USA.
David BrottAstraZeneca, Gaithersburg, Maryland, USA.
Rachel ChurchDepartment of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.
Ajit DashGenentech, South San Francisco, California, USA.
Douglas KellerSanofi, Bridgewater, New Jersey, USA.
Philip SherrattCelgene, Summit, New Jersey, USA.
Paul B WatkinsDepartment of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.
Lucas Westcott-BakerOtsuka PDC, Rockville, Maryland, USA.
Silvia LentiniBayer, Wuppertal, Germany.
Michael MerzAstraZeneca, Gaithersburg, Maryland, USA.
Lila RamaiahPfizer, Cambridge, Massachusetts, USA.
Shashi K RamaiahPfizer, Cambridge, Massachusetts, USA.
Ann Marie StanleyIQ DILI Consortium, Washington, DC, USA.
John MarcinakTakeda, Deerfield, Illinois, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The diagnosis and management of drug-induced liver injury (DILI) remains a challenge in clinical trials in drug development. The qualification of emerging biomarkers capable of predicting DILI soon after the initiation of treatment, differentiating DILI from underlying liver disease, identifying the causal entity, and assigning appropriate treatment options after DILI is diagnosed are needed. Qualification efforts have been hindered by lack of properly stored and consented biospecimens that are linked to clinical data relevant to a specific context of use. Recommendations are made for biospecimen collection procedures, with the focus on clinical trials, and for specific emerging biomarkers to focus qualification efforts.

Indexed as

BiomarkersChemical and Drug Induced Liver InjuryClinical Trials as TopicDrug DevelopmentHumansInformed ConsentLiver Function TestsPhenotypeSpecimen HandlingBiomarkers

Identifiers

PMID31314926
PMCPMC7006882

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.