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

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This study developed a core data element framework to standardize pregnancy pharmacovigilance (PregPV) data collection. This framework aims to improve the quality and harmonization of data for better medication safety assessments in pregnancy.

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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.