Evidence map›Paper›PMID 35143713›Full record

ReviewCPT: pharmacometrics & systems pharmacology2022

Advancing drug safety science by integrating molecular knowledge with post-marketing adverse event reports.

Theodoros G Soldatos, Sarah Kim, Stephan Schmidt, Lawrence J Lesko, David B Jackson

Abstract readReview
In one paragraph

Review in CPT: pharmacometrics & systems pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Quantitative approaches to drug safety: The 2022 PSP special issue.CPT: pharmacometrics & systems pharmacology · 2022
    Article
  8. 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

5 authors.

Theodoros G SoldatosMolecular Health GmbH, Heidelberg, Germany.ORCID 0000-0001-6051-6605
Sarah KimDepartment of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, Florida, USA.ORCID 0000-0002-9179-0735
Stephan SchmidtDepartment of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, Florida, USA.
Lawrence J LeskoDepartment of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, Florida, USA.
David B JacksonMolecular Health GmbH, Heidelberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Promising drug development efforts may frequently fail due to unintended adverse reactions. Several methods have been developed to analyze such data, aiming to improve pharmacovigilance and drug safety. In this work, we provide a brief review of key directions to quantitatively analyzing adverse events and explore the potential of augmenting these methods using additional molecular data descriptors. We argue that molecular expansion of adverse event data may provide a path to improving the insights gained through more traditional pharmacovigilance approaches. Examples include the ability to assess statistical relevance with respect to underlying biomolecular mechanisms, the ability to generate plausible causative hypotheses and/or confirmation where possible, the ability to computationally study potential clinical trial designs and/or results, as well as the further provision of advanced features incorporated in innovative methods, such as machine learning. In summary, molecular data expansion provides an elegant way to extend mechanistic modeling, systems pharmacology, and patient-centered approaches for the assessment of drug safety. We anticipate that such advances in real-world data informatics and outcome analytics will help to better inform public health, via the improved ability to prospectively understand and predict various types of drug-induced molecular perturbations and adverse events.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsHumansMachine LearningMarketingPharmacovigilance

Identifiers

PMID35143713
PMCPMC9124355

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.