Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project.

Guillaume FavreJonathan L RichardsonAlan MooreYvonne GeissbühlerValentine JehlAlison OliverSvetlana ShechtmanOrna Diav-CitrinMaya BerlinTal De HaanDavid BaudAlice PanchaudAnil MorMeritxell SabidóSabrina de SouzaChristina ChambersYrea R J van Rijt-WeetinkEugène P van PuijenbroekLaura M YatesFrançois GirardinMichael StellfeldUrsula Winterfeld

Published in: Drug safety (2023)

Data access providers participating in this study presented a very high proportion of variables matching the CDE items, indicating that alignment of definitions and harmonisation of data analysis by different stakeholders to accelerate and strengthen pregnancy pharmacovigilance safety data analyses could be feasible.

Keyphrases

data analysis
electronic health record
big data
healthcare
preterm birth
adverse drug
pregnancy outcomes
health insurance
drug induced