Teratogenic Risk Impact and Mitigation (TRIM)
Funded by the FDA, TRIM aims to provide comprehensive evidence on prenatal exposure to teratogenic drugs and develop a new decision tool to evaluate and prioritize teratogenic medications for risk mitigation programs.
Specific aims
Preventing prenatal exposure to teratogenic drugs is one of the most prominent targets for the FDA’s risk mitigation efforts. Our recent work shows that more than one in 100 pregnancies have prenatal exposure to drugs with definite teratogenic risk and about one in 20 pregnancies are exposed to medications with potential teratogenic risk. Funded by the FDA, this project aims to provide FDA with comprehensive evidence on prenatal exposure to teratogenic drugs to evaluate the current public health impact and need for enhanced risk mitigation.
Our specific aims include:
(1) Quantify the overall prevalence of prenatal exposure to teratogenic medications and rank drugs based on their relative contribution to prenatal exposure as well as in the context of their overall utilization among women of child-bearing age.
(2) Develop TRIM, a decision-making tool that considers multiple explicit criteria to prioritize drugs for REMS implementation based on FDA’s decision framework.
(3) Use TRIM to rank the top 12 teratogenic drugs without REMS that contribute to overall fetal exposure and all 12 drugs with current or previous REMS.
Special features
The project incorporates input from 30 clinical and scientific experts to develop an innovative, evidence-based decision tool that uses quantifiable criteria to allow prioritization of drugs for further risk mitigation. TRIM’s utility is not limited to future drug approvals, but also applicable to re-evaluation of drugs that are currently approved without REMS and those that require REMS. Its innovative methods and its focus on evidence critical for regulatory and clinical decision-making to minimize fetal harm are in line with FDA’s mission to advance Regulatory Science and Innovation and to enhance the Safe Use of Medications.
Publications
Drug Safety
Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation
Drug safety
Teratogenic Risk Impact Mitigation (TRIM): Development of Explicit Criteria to Facilitate Decisions Regarding Teratogenic Risk Mitigation Strategies
Study team
Principal investigator (MPI)
Almut G Winterstein, RPh, PhD, FISPE
Distinguished Professor in Pharmaceutical Outcomes & Policy, Director Center for Drug Evaluation & Safety, University of Florida
co-investigator
Judy Maro, MS, PhD
Assistant Professor on Population Medicine, Harvard Medical School
co-investigator
Sonja A Rasmussen, MD, MS
Professor of Genetic Medicine, Johns Hopkins Medicine
co-investigator
Nicole Smolinski, PharmD, PhD
Research Assistant Professor, Pharmaceutical Outcomes & Policy, University of Florida
Data Scientist
Yanning Wang, MS
PhD Student, Data Scientist, Pharmaceutical Outcomes & Policy, University of Florida
Project Coordinator
Celeste Ewig, PharmD
PhD Student, Pharmaceutical Outcomes & Policy, University of Florida
