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May 14, 2026Frontiers in Drug Safety and Regulation0 citationsOpen Access

Outcomes of Post-Approval Safety Studies in Pregnancy: Need for Standardization

Outcomes of post-approval non-interventional safety studies in pregnancy: wide variation demonstrates need for further standardization

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Authors

SCStacy ChenSMSarah C. MacDonald

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Overview

A retrospective analysis of outcomes from post-approval safety studies highlights the need for standardized evaluation in pregnancy, suggesting improved data comparability.

Key Points

  • The aim is to summarize outcomes assessed in post-approval safety studies during pregnancy and evaluate how study characteristics influence these outcomes.
  • Query of post-approval safety studies registered on HMA-EMA Catalogue of Real-world Data Studies
  • Evaluation of protocols and outcomes across included studies
  • Assessment of factors influencing outcome reporting
  • Out of 3100 studies, 30 met eligibility for inclusion, showing stillbirth in 25 studies and congenital malformations in 24 studies.
  • Study characteristics influenced outcome variability, with no universal outcomes evaluated across all studies.
  • Sample sizes were generally low with a median of 110, limiting the power to analyze key outcomes like stillbirth.
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Chen et al. (2026) studied this question.

synapsesocial.com/papers/6a05659da550a87e60a1deaahttps://doi.org/10.3389/fdsfr.2026.1805759
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