In this course, faculty will present and discuss considerations related to designing studies on the safety of medical products in pregnancy within the framework of target trial emulation. The course will consist of presentations by four faculty (general overview on evaluating the safety of medical products in pregnancy; target trial emulation framework; concrete applications to pregnancy pharmacoepidemiology). Talks will be followed by a practical component in which course registrants will apply the core course concepts in groups. In case of a virtual/remote delivery of this course, the practical session may be omitted.
We aim to cover new topics each year, while still providing a general overview for participants who are newer to the field. In 2015, the course provided an overview of issues that are particular to research on the safety of medical products in pregnancy. In 2016 the course focused on challenges related to exposure measurement, in 2017 the focus was on maternal and neonatal outcomes, and in 2018 the course presented pros and cons of various study designs. In 2019, the course discussed significance testing and analytical approaches to address biases. The content of the 2020 edition covered some of the main themes discussed in previous years. In 2021, we discussed to maternal and immediate and long-term offspring outcomes. In 2022, the course will discuss considerations when conducting pregnancy pharmacoepidemiologic research within the framework of target trial emulation, an approach which is gaining popularity.
