Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods:...

Area of Science:

• Pharmacovigilance
• Pharmacoepidemiology
• Reproductive Toxicology

Background:

• Medication safety in pregnancy is typically assessed via post-marketing observational studies.
• Current pregnancy pharmacovigilance (PregPV) data collection lacks standardization, leading to heterogeneous and difficult-to-interpret results.
• There is a need for systematic approaches to improve medication safety data in pregnancy.

Approach:

• Developed a reference framework of core data elements (CDEs) for primary source pregnancy pharmacovigilance (PregPV) studies.
• The framework was created by a multidisciplinary expert group within the IMI ConcePTION project, involving a scoping review and extensive expert discussion.
• The finalized framework includes 98 data elements organized into 14 tables and is publicly available.

Key Points:

• The framework aims to standardize data collection in PregPV studies.
• Improved data harmonization and evidence synthesis capabilities are expected outcomes.
• The ultimate goal is to expedite the provision of high-quality, evidence-based information on medication safety during pregnancy.

Conclusions:

• The developed CDE framework provides recommendations to standardize PregPV primary source data collection.
• Standardization will accelerate the provision of high-quality, evidence-based statements on medication safety during pregnancy.
• This initiative aims to improve the reliability and interpretability of PregPV research findings.