Evidence map›Paper›PMID 37077840›Full record

ReviewBiomarker insights2023

The Use of Biomarkers in Pharmacovigilance: A Systematic Review of the Literature.

Maribel Salas, Maxine Gossell-Williams, Priyanka Yalamanchili, Sameer Dhingra, Marina A Malikova, Omar Aimer, Toluwalope Junaid

Abstract readReview
In one paragraph

Review in Biomarker insights, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

Maribel SalasDaiichi Sankyo, Inc., Basking Ridge, NJ, USA.ORCID https://orcid.org/0000-0001-5634-1558
Maxine Gossell-WilliamsSection of Pharmacology and Pharmacy, The University of the West Indies, Kingston, Jamaica.ORCID https://orcid.org/0000-0003-4268-5960
Priyanka YalamanchiliDaiichi Sankyo, Inc., Basking Ridge, NJ, USA.ORCID https://orcid.org/0000-0002-5290-8665
Sameer DhingraDepartment of Pharmacy Practice, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, India.
Marina A MalikovaSchool of Medicine, Boston University, Boston, MA, USA.
Omar AimerInnovigilance, Laval, QC, Canada.
Toluwalope JunaidSyneos Health, Morrisville, NC, USA.ORCID https://orcid.org/0000-0003-3097-4159

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The use of biomarkers varies from disease etiognosis and diagnosis to signal detection, risk prediction, and management. Biomarker use has expanded in recent years, however, there are limited reviews on the use of biomarkers in pharmacovigilance and specifically in the monitoring and management of adverse drug reactions (ADRs). Objective: The objective of this manuscript is to identify the multiple uses of biomarkers in pharmacovigilance irrespective of the therapeutic area. Design: This is a systematic review of the literature. Data Sources and Methods: Embase and MEDLINE database searches were conducted for literature published between 2010-March 19, 2021. Scientific articles that described the potential use of biomarkers in pharmacovigilance in sufficient detail were reviewed. Papers that did not fulfill the United States Food and Drug Administration (US FDA) definition of a biomarker were excluded, which is based on the International Conference on Harmonisation (ICH)-E16 guidance. Results: Twenty-seven articles were identified for evaluation. Most articles involved predictive biomarkers (41%), followed by safety biomarkers (38%), pharmacodynamic/response biomarkers (14%), and diagnostic biomarkers (7%). Some articles described biomarkers that applied to multiple categories. Conclusion: Various categories of biomarkers including safety, predictive, pharmacodynamic/response, and diagnostic biomarkers are being investigated for potential use in pharmacovigilance. The most frequent potential uses of biomarkers in pharmacovigilance in the literature were the prediction of the severity of an ADR, mortality, response, safety, and toxicity. The safety biomarkers identified were used to evaluate patient safety during dose escalation, identify patients who may benefit from further biomarker testing during treatment, and monitor ADRs.

Indexed as

Biomarkerspatient safetypharmacovigilance

Identifiers

PMID37077840
PMCPMC10108426

What OpenQuestion holds

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LicenceCC BY-NC
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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.