Föreläsningar och seminarier Target Trial Emulations to Study Drug Safety During Pregnancy

Speaker: Carole Marxer, Postdoctoral Researcher, Department of Medical Epidemiology and Biostatistics (MEB)

Abstract
Pregnant women are usually excluded from randomized controlled trials (RCTs) due to ethical concerns. Even when pregnant women are included, RCTs are often underpowered to adequately assess safety, particularly because the timing of exposure during pregnancy is crucial. Exposures occurring at different gestational time points may be associated with different types of outcomes—for example, first-trimester exposures are particularly relevant for the risk of congenital malformations among offspring. Thus, evidence generated from observational data remains an important source for studying the safety of medications during pregnancy.

Furthermore, maternal age at delivery is increasing in most high-income countries, accompanied by a higher prevalence of comorbidities requiring treatment during pregnancy. This trend highlights the importance of well-designed observational studies, including those applying the target trial emulation (TTE) framework, to evaluate the safety of medications during pregnancy. Although TTE studies are becoming more common to study drug safety during pregnancy, the number of well-designed and methodologically rigorous studies remains limited compared to other populations. This seminar will give an overview about considerations, challenges, as well as strengths and limitations of TTE studies in pregnant women.