Evidence map›Paper›PMID 27663477›Full record

ReviewSeminars in oncology2016

Translating pharmacodynamic biomarkers from bench to bedside: analytical validation and fit-for-purpose studies to qualify multiplex immunofluorescent assays for use on clinical core biopsy specimens.

Allison Marrero, Scott Lawrence, Deborah Wilsker, Andrea Regier Voth, Robert J Kinders

Abstract readReview
In one paragraph

Review in Seminars in oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Standards for Quantitative Measurement of DNA Damage in Mammalian Cells.International journal of molecular sciences · 2023
    Review
  6. Article
  7. Article
  8. Evaluation of Pharmacodynamic Responses to Cancer Therapeutic Agents Using DNA Damage Markers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Article
  9. The Challenge for Development of Valuable Immuno-oncology Biomarkers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
    Article
  10. Article
  11. 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

5 authors.

Allison MarreroPharmacodynamics Assay Development and Implementation Section, Laboratory of Human Toxicology and Pharmacology, Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Frederick, MD.
Scott LawrencePharmacodynamics Assay Development and Implementation Section, Laboratory of Human Toxicology and Pharmacology, Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Frederick, MD.
Deborah WilskerPharmacodynamics Assay Development and Implementation Section, Laboratory of Human Toxicology and Pharmacology, Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Frederick, MD.
Andrea Regier VothPharmacodynamics Assay Development and Implementation Section, Laboratory of Human Toxicology and Pharmacology, Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Frederick, MD.
Robert J KindersPharmacodynamics Assay Development and Implementation Section, Laboratory of Human Toxicology and Pharmacology, Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Frederick, MD. Electronic address: kindersr@mail.nih.gov.

Funding

CCR NIH HHS HHSN261200800001CIntramural NIH HHS Z99 CA999999NCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

Multiplex pharmacodynamic (PD) assays have the potential to increase sensitivity of biomarker-based reporting for new targeted agents, as well as revealing significantly more information about target and pathway activation than single-biomarker PD assays. Stringent methodology is required to ensure reliable and reproducible results. Common to all PD assays is the importance of reagent validation, assay and instrument calibration, and the determination of suitable response calibrators; however, multiplex assays, particularly those performed on paraffin specimens from tissue blocks, bring format-specific challenges adding a layer of complexity to assay development. We discuss existing multiplex approaches and the development of a multiplex immunofluorescence assay measuring DNA damage and DNA repair enzymes in response to anti-cancer therapeutics and describe how our novel method addresses known issues.

Indexed as

Antineoplastic AgentsBiomarkers, TumorBiopsy, Large-Core NeedleCalibrationChemistry, ClinicalDNA RepairEnzymesFluorescent Antibody TechniqueHumansImage Processing, Computer-AssistedNeoplasmsProtein Array AnalysisQuality ControlReproducibility of ResultsAntineoplastic AgentsBiomarkers, TumorEnzymesAssay validationCancer drugClinical samplesFitness-for-purposeMultiplex assayTargeted therapy

Identifiers

PMID27663477
PMCPMC5065024

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.