The U.S. Food and Drug Administration, or FDA, has awarded the Harvard Brigham and Women’s Hospital and the University of Florida College of Pharmacy a nearly $3 million grant to develop methods for the assessment of medication safety during pregnancy. The study will enhance the FDA’s capability to conduct drug safety studies on maternal and infant outcomes involving exposure to medications during pregnancy.
Almut Winterstein, Ph.D., a professor and chair of pharmaceutical outcomes and policy in the UF College of Pharmacy, and researchers at Harvard’s Program in Perinatal and Pediatric Pharmacoepidemiology, will develop and validate Medicaid-specific algorithms to estimate gestational age for live birth pregnancies. In addition, they will develop analytical tools to assess the impact on risk estimates of exposure misclassification, outcome misclassification, selection bias and residual confounding in pregnancy drug safety studies.
Pregnant women are generally excluded from clinical trials due to concerns about drug safety for mothers and children, which makes this population one of the most important targets for post-marketing observational studies. Observational studies take advantage of the fact that exposure to drugs during pregnancy will inadvertently happen in real life. Because of the biology of fetal development, drug exposure may have different effects at different times of pregnancy, which means that accurate timing of conception is critical to fully describe and quantify drug risk. Because conception is typically unknown, gestational age is used to approximate conception. This study will develop tools that improve current estimates of conception and allow sensitivity analysis to assess the degree of bias that may affect drug safety studies because of inaccurate measurement.