Drug Safety in Pregnancy in a Large, Multisite Database: Advances in Analytic Methods, Querying Tools, and supplemental Data Collection from Patients

Speakers: Elizabeth Suarez, Academic Researcher, Danijela Stojanovic, PhD, FDA; Sentinel Core Team, David Martin, MD, FDA; FDA Catalyst lead,
Susan Sinclair, PhD, RN, University of North Carolina Wilmington


The webinar will consist of 4 presentations (approximately 10 minutes each). Speakers include the FDA’s Sentinel Core Team member, two academic Sentinel investigators, and the FDA-Catalyst lead.

 Danijela Stojanovic (FDA; Sentinel Core Team) will present descriptive data regarding a new mother-infant linkage developed in the Sentinel System that will be refreshed routinely, and a new reusable propensity score matched analytic tool to run on against the linked dataset whose code will be posted online for public use.

Liz Suarez (Academic Researcher) will present a new ICD-10 based algorithm to identify the gestational age for live births, which is foundational to virtually all comparative drug safety studies in pregnancy. 

Susan Andrade (Academic Researcher) will present an ongoing project on the validation of an ICD-10 based algorithm to identify stillbirth in the Sentinel System.

David Martin (FDA; FDA Catalyst lead) will describe the “FDA My Studies App” system which includes an iOS and Android compatible mobile app, a web-based study design tool, and a secure patient data storage environment which was used in a pilot study of medication exposures, other risk factors, and pregnancy outcomes.


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