FDA
Teratogenic Risk Impact and Mitigation (TRIM): An Evidence-based Decision Framework
Principal Investigator: Almut Winterstein
Objective: This study aims to develop an innovative, evidence-based decision tool that uses quantifiable criteria to allow prioritization of drugs for further risk mitigation. Harnessing data from billing and vital records and synthesizing existing evidence, we will employ the newly developed TRIM Decision Tool to prioritize drugs for risk mitigation.
State of Florida
Consortium for Medical Marijuana Clinical Outcomes Research
Principal investigators: Almut Winterstein & Robert Cook
Objectives: State appropriation supports the Consortium for medical marijuana clinical outcomes research, to generate and disseminate evidence on the outcomes of the medical use of marijuana to inform clinical and policy decisions.
CDC
Emerging Infections and Treatment in Pregnancy (EI-TIP)
Principal investigators: AG Winterstein & S Rasmussen
Objective: This study employs linked mother baby cohorts to study two focus areas involving the risk and benefits and treatment determinants of emerging infections during pregnancy.
NICHD
Big data apprOaches fOr Safe Therapeutics in Healthy Pregnancies (BOOST)
Principal investigators: Judy Maro & Almut Winterstein
Objectives: In this study we will combine innovative data-mining techniques that can evaluate multiple drugs and outcomes simultaneously with formal assessments of prioritized safety signals obtained from data-mining to accelerate evidence generation on the safety of medications during pregnancy.
Bill and Melinda gates foundation
Drug-Drug Interactions with Hormonal Contraceptives
Principal investigators: S Schmidt; J Brown & AG Winterstein for RWE study component
Objectives: This study characterizes hormonal contraceptive utilization patterns and evaluates adverse events from drug-drug interactions including risk for unplanned pregnancy
CDC
Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet)
Principal Investigator: Almut Winterstein
Objective: This study aims to utilize data from routine surveillance of individuals with muscular dystrophy to improve the quality of care and lives of patients with this condition.
