Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation
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.
Authors
- Leila G. Lackey (ORCID: https://orcid.org/0000-0001-8434-2638)
- Sara Eggers
- Amir Sarayani (ORCID: https://orcid.org/0000-0003-2790-9938)
- Gita A. Toyserkani (ORCID: https://orcid.org/0000-0002-6946-6138)
- Yanning Wang (ORCID: https://orcid.org/0000-0002-4263-3944)
- Celeste L. Y. Ewig (ORCID: https://orcid.org/0000-0001-7372-3697)
- Esther H. Zhou (ORCID: https://orcid.org/0000-0003-4608-6850)
- Cynthia LaCivita (ORCID: https://orcid.org/0009-0001-8680-9008)
- Nicole E. Smolinski (ORCID: https://orcid.org/0000-0002-0866-4579)
- Almut G. Winterstein (ORCID: https://orcid.org/0000-0002-6518-5961)
- Sonja A. Rasmussen (ORCID: https://orcid.org/0000-0002-0574-4928)
- Judith C. Maro (ORCID: https://orcid.org/0000-0001-9900-2142)
- Vakaramoko Diaby (ORCID: https://orcid.org/0000-0002-6251-0773)
- Thuy Nhu Thai (ORCID: https://orcid.org/0000-0003-4544-1160)
Institutions
- Johnson & Johnson (United States) (US)
- Center for Drug Evaluation and Research (US)
- Harvard University (US)
- Johns Hopkins University (US)
- Johns Hopkins Medicine (US)
- University of Florida (US)
- Otsuka (United States) (US)
- Harvard Pilgrim Health Care (US)
- Janssen (United States) (US)
- Florida College (US)
Publication Details
- Journal
- Drug Safety
- Published
- 2024-11-05
- DOI
- https://doi.org/10.1007/s40264-024-01488-4
- Citations
- 1
- Primary Topic
- Pregnancy and Medication Impact
- Type
- article
- Field-Weighted Citation Impact
- 0.54
Funders
- U.S. Food and Drug Administration