Evidence map›Paper›PMID 40762949›Full record

ArticleDrug safety2025

Teratogenic Risk Impact Mitigation (TRIM): Development of Explicit Criteria to Facilitate Decisions Regarding Teratogenic Risk Mitigation Strategies.

Celeste L Y Ewig, Yanning Wang, Nicole E Smolinski, Gita A Toyserkani, Cynthia LaCivita, Leila Lackey, Sara Eggers, Leyla Sahin, Reem S Abu-Rustum, Brian T Bateman and 27 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

37 authors.

Celeste L Y EwigDepartment of Pharmaceutical Outcomes and Policy, University of Florida, College of Pharmacy, Malachowsky Hall, 1889 Museum Road, Suite 6300, Gainesville, FL, 32611, USA.
Yanning WangDepartment of Pharmaceutical Outcomes and Policy, University of Florida, College of Pharmacy, Malachowsky Hall, 1889 Museum Road, Suite 6300, Gainesville, FL, 32611, USA.
Nicole E SmolinskiDepartment of Pharmaceutical Outcomes and Policy, University of Florida, College of Pharmacy, Malachowsky Hall, 1889 Museum Road, Suite 6300, Gainesville, FL, 32611, USA.
Gita A ToyserkaniCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Cynthia LaCivitaIndependent, Potomac, 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.
Leyla SahinCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Reem S Abu-RustumDepartment of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, FL, USA.
Brian T BatemanStanford University School of Medicine, Palo Alto, CA, USA.
Anick BerardFaculty of Pharmacy, University of Montreal; and CHU Sainte-Justine, Montreal, Canada.
Christina D ChambersUniversity of California, San Diego, CA, USA.
Beth ChobyIndependent, Memphis, TN, USA.
Elizabeth A ConoverUniversity of Nebraska Medical Center, Omaha, NE, USA.
Michael F GreeneDepartment of Obstetrics and Gynecology, Harvard Medical School, Boston, MA, USA.
Sonia Hernández-DíazDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Denise J JamiesonUniversity of Iowa Health Care, Iowa City, IA, USA.
Sarah G ObičanDepartment of Obstetrics and Gynecology, University of South Florida, Tampa, FL, USA.
Janine E PolifkaUniversity of Washington, Seattle, WA, USA.
Kay Roussos-RossDepartments of OBGYN, Psychiatry, University of Florida, Gainesville, FL, USA.
Jeanne S SheffieldJohns Hopkins Medicine, Baltimore, MD, USA.
Sharon Voyer LavigneUConn Health, Farmington, CT, USA.
Ellen M ZimmermannDivision of Gastroenterology, Hepatology and Nutrition, University of Florida, Gainesville, FL, USA.
Susan B LaffanAmgen R&D, Translational Safety and Bioanalytical Sciences, Thousand Oaks, CA, USA.
Anthony M DeLiseNovartis Pharmaceutical Company, East Hanover, NJ, USA.
Alicia W GilsenanRTI Health Solutions, Research Triangle Park, NC, USA.
Tarek A HammadTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Christian HamppRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Janet R HardyIndependent, Greater Montreal, Quebec, Canada.
Caitlin A KnoxRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Kristine ShieldsIndependent, Philadelphia, PA, USA.
Meredith Y SmithEvidera, Inc., New London, NH, USA.
Rachel E SobelRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Melissa S TassinariIndependent, Harwich Port, 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 University School of Medicine, Baltimore, MD, USA.
Almut G WintersteinDepartment of Pharmaceutical Outcomes and Policy, University of Florida, College of Pharmacy, Malachowsky Hall, 1889 Museum Road, Suite 6300, Gainesville, FL, 32611, USA. almut@ufl.edu.ORCID http://orcid.org/0000-0002-6518-5961

Funding

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

Abstract

backgroundPreventing fetal exposure to teratogenic medications is an important target for risk mitigation efforts. Decisions about risk mitigation efforts specific to teratogenic medications are complex.

objectivesThe Teratogenic Risk Impact and Mitigation (TRIM) tool was developed as an innovative decision support tool to facilitate prioritization of teratogenic medications for risk mitigation strategies.

methodsWe employed a modified Delphi study design involving experts across teratology, obstetrics/gynecology, and medication safety. Panelists proposed decision criteria in three focus groups, followed by e-Delphi rounds to reach a consensus on criteria regarding three dimensions: (1) completeness; (2) relevance; and (3) distinctiveness. Aggregated feedback from each round was used to inform revision of the criteria in subsequent rounds.

resultsA total of 33 candidate criteria proposed by 32 focus group participants were organized into ten distinct criteria for the Delphi process. Consensus (defined as > 85% agreement on all three dimensions) was reached after three e-Delphi rounds, resulting in six criteria: (1) background use among persons of reproductive potential; (2) overall medication benefit considering severity of the indication and availability of alternatives; (3) seriousness of the teratogenic outcome; (4) risk of the teratogenic outcome; (5) certainty regarding teratogenicity; and (6) the risk of exposure during pregnancy.

conclusionsWe established measurable criteria to inform decisions when prioritizing teratogenic medications for risk mitigation programs. Criteria are consensus based and consistent with relevant regulatory guidance. Future work will operationalize these criteria and determine specific weights to facilitate medication-specific TRIM scores. Through its explicit framework, the TRIM tool may support consistent, transparent, and rational decision making and help optimize the contribution of risk mitigation programs to public health.

Indexed as

Abnormalities, Drug-InducedDecision Support TechniquesRisk Evaluation and MitigationTeratogensConsensusDelphi TechniqueFemaleFocus GroupsHumansPregnancyRisk AssessmentTeratogens

Identifiers

PMID40762949
PMCPMC12605566

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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.