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; Anick Berard; Christina D Chambers; Beth Choby; Elizabeth A Conover; Michael F Greene; Sonia Hernández-Díaz; Denise J Jamieson; Sarah G Običan; Jeanne S Sheffield; Janine E Polifka; Sharon Voyer Lavigne; Kay Roussos-Ross; Ellen M Zimmermann; Susan B Laffan; Anthony M DeLise; Alicia W Gilsenan; Tarek A Hammad; Christian Hampp; Janet R Hardy; Caitlin A Knox; Kristine Shields; Meredith Y Smith; Rachel E Sobel; Melissa S Tassinari; Judith C Maro; Sonja A Rasmussen; Almut G Winterstein

doi:10.1007/s40264-025-01581-2

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

Journal article

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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, …

Drug safety, Vol.48(12), pp.1387-1397

12/2025

DOI: 10.1007/s40264-025-01581-2

PMCID: PMC12605566

PMID: 40762949

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Abstract

Preventing fetal exposure to teratogenic medications is an important target for risk mitigation efforts. Decisions about risk mitigation efforts specific to teratogenic medications are complex. The 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. We 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. A 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. We 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.

Details

Title: Subtitle: Teratogenic Risk Impact Mitigation (TRIM): Development of Explicit Criteria to Facilitate Decisions Regarding Teratogenic Risk Mitigation Strategies
Creators: Celeste L Y Ewig - Florida College
Yanning Wang - Florida College
Nicole E Smolinski - Florida College
Gita A Toyserkani - Center for Drug Evaluation and Research
Cynthia LaCivita - University of the Potomac
Leila Lackey - Center for Drug Evaluation and Research
Sara Eggers - Center for Drug Evaluation and Research
Leyla Sahin - Center for Drug Evaluation and Research
Reem S Abu-Rustum - Florida College
Brian T Bateman - Palo Alto University
Anick Berard - Centre Hospitalier Universitaire Sainte-Justine
Christina D Chambers - University of California San Diego
Beth Choby - Independent, Memphis, TN, USA
Elizabeth A Conover - University of Nebraska Medical Center
Michael F Greene - Harvard University
Sonia Hernández-Díaz - Harvard University
Denise J Jamieson - University of Iowa
Sarah G Običan - University of South Florida
Jeanne S Sheffield - Johns Hopkins Medicine
Janine E Polifka - University of Washington
Sharon Voyer Lavigne - UConn Health
Kay Roussos-Ross - University of Florida
Ellen M Zimmermann - University of Florida
Susan B Laffan - Amgen
Anthony M DeLise - Tris Pharma
Alicia W Gilsenan - RTI Health Solutions
Tarek A Hammad - Takeda
Christian Hampp - Regeneron
Janet R Hardy - Independent, Greater Montreal, Quebec, Canada
Caitlin A Knox - Regeneron
Kristine Shields - ProQuest
Meredith Y Smith - Ithaka Harbors
Rachel E Sobel - Regeneron
Melissa S Tassinari - Independent, Harwich Port, MA, USA
Judith C Maro - Harvard Pilgrim Health Care
Sonja A Rasmussen - Johns Hopkins Medicine
Almut G Winterstein - Florida College
Resource Type: Journal article
Publication Details: Drug safety, Vol.48(12), pp.1387-1397
DOI: 10.1007/s40264-025-01581-2
PMID: 40762949
PMCID: PMC12605566
NLM abbreviation: Drug Saf
ISSN: 0114-5916
eISSN: 1179-1942
Publisher: Springer Nature
Grant note: HHS75F40121C00188 / U.S. Food and Drug Administration
Language: English
Electronic publication date: 08/05/2025
Date published: 12/2025
Academic Unit: Obstetrics and Gynecology; VPMA - Administration
Record Identifier: 9984945083402771

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