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, Amir Sarayani, Thuy Thai, Judith C. Maro and Sonja A. Rasmussen
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Almut G. Winterstein: University of Florida
Celeste L. Y. Ewig: University of Florida
Yanning Wang: University of Florida
Nicole E. Smolinski: University of Florida
Gita A. Toyserkani: Center for Drug Evaluation and Research, Food and Drug Administration
Cynthia LaCivita: Center for Drug Evaluation and Research, Food and Drug Administration
Leila Lackey: Center for Drug Evaluation and Research, Food and Drug Administration
Sara Eggers: Center for Drug Evaluation and Research, Food and Drug Administration
Esther H. Zhou: Center for Drug Evaluation and Research, Food and Drug Administration
Vakaramoko Diaby: Otsuka Pharmaceutical Development Corporation Inc
Amir Sarayani: Johnson & Johnson
Thuy Thai: Harvard Medical School and Harvard Pilgrim Health Care Institute
Judith C. Maro: Harvard Medical School and Harvard Pilgrim Health Care Institute
Sonja A. Rasmussen: Johns Hopkins School of Medicine

Drug Safety, 2025, vol. 48, issue 2, No 1, 107-117

Abstract: Abstract Introduction Preventing 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. Objectives This study aims to develop an innovative decision support tool that uses explicit, quantifiable criteria to facilitate prioritization of teratogenic medications for risk mitigation strategies. Methods The 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. Conclusions Teratogenic 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.

Date: 2025
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DOI: 10.1007/s40264-024-01488-4

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