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

Regulators and sponsors are increasingly embracing multisite administrative and electronic health record databases, but studying the safety of marketed drugs in pregnancy remains challenging.

This webinar described new methods and tools developed in FDA’s multisite Sentinel System that allow for the evaluation of medication safety in pregnancy.

Date: Friday, November 30, 2018
Time: 10:00 - 11:00am EDT

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

Danijela Stojanovic (FDA; Sentinel Core Team) presented descriptive data regarding a new mother-infant linkage table 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.

Elizabeth Suarez (Academic Researcher) presented 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) presented 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) described 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.