Evidence map›Paper›PMID 39499480›Full record

ArticleDrug safety2025

Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation.

Almut G Winterstein, Celeste L Y Ewig, Yanning Wang, Nicole E Smolinski, Gita A Toyserkani, Cynthia LaCivita, Leila Lackey, Sara Eggers, Esther H Zhou, Vakaramoko Diaby and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Applied behavioral and decision sciences in support of US FDA's drug regulatory mission.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  2. Article
  3. 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

14 authors.

Almut G WintersteinDepartment of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA. almut@ufl.edu.ORCID 0000-0002-6518-5961
Celeste L Y EwigDepartment of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA.
Yanning WangDepartment of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA.
Nicole E SmolinskiDepartment of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA.
Gita A ToyserkaniCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Cynthia LaCivitaCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Leila LackeyCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Sara EggersCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Esther H ZhouCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Vakaramoko DiabyHealth Economics and Value Evidence Partnership, Otsuka Pharmaceutical Development Corporation Inc, Princeton, NJ, USA.
Amir SarayaniJanssen Research and Development, Johnson & Johnson, Brisbane, CA, USA.
Thuy ThaiDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Judith C MaroDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Sonja A RasmussenDepartment of Genetic Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.

Funding

U.S. Food and Drug Administration HHS75F40121C00188
6 · The paper itself

Abstract

introductionPreventing prenatal exposure to teratogenic medications is an important goal of regulatory risk mitigation efforts. In the USA, as of March 2024, 11 teratogenic medications have a required Risk Evaluation and Mitigation Strategy (REMS) program. It is unclear whether these programs target those medications with the most significant impact on public health and adverse pregnancy outcomes.

objectivesThis study aims to develop an innovative decision support tool that uses explicit, quantifiable criteria to facilitate prioritization of teratogenic medications for risk mitigation strategies.

methodsThe Teratogenic Risk Impact and Mitigation (TRIM) decision support tool will be developed by a national panel via a modified Delphi approach to define measurable criteria, and a multi-criteria decision analysis to estimate criteria weights within a discrete choice experiment. The TRIM scores will then be calculated for 12 teratogenic drugs with active or eliminated REMS programs and for 12 teratogenic drugs without REMS. These drugs will be identified based on highest prenatal exposure prevalence in claims data of privately and publicly insured individuals. Data for the TRIM criteria levels for these 24 drugs will be identified from evidence searches and ad hoc analyses of the same claims data.

conclusionsTeratogenic Risk Impact and Mitigation is intended to inform regulatory decision making about the need for risk mitigation programs for teratogenic medications by providing explicit, quantifiable, evidence-based criteria. The TRIM scores of 24 teratogenic drugs may provide benchmarks for considering REMS for marketed and new teratogenic medications.

Indexed as

Abnormalities, Drug-InducedDecision Support TechniquesRisk Evaluation and MitigationTeratogensDelphi TechniqueFemaleHumansPregnancyRisk AssessmentUnited StatesTeratogens

Identifiers

PMID39499480
PMCPMC11785626

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Registered trials

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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.