Inclusion of Pregnant and Lactating Persons in Clinical Trials Gains Momentum Internationally

Strategic Insights -

Researchers have highlighted the need for more representative and inclusive clinical trials that account for the unique needs of pregnant and lactating individuals. According to a recent study, there is a lack of knowledge among health care providers and patients about clinical trials during pregnancy, making it challenging to engage them in discussions about participation. A multidisciplinary approach is being proposed to develop guidance for researchers, clinicians, industry, and regulatory agencies to promote safe participation.

Key Takeaways:

  • A multidisciplinary panel, "Designing for Dyads," was held at the 2024 Increasing capacity for Maternal and Paediatric Clinical Trials summit in Vancouver, BC, Canada, to discuss the inclusion of pregnant and lactating persons and their infants in clinical trials.
  • The panel highlighted the need for additional considerations in clinical trials, including alterations in pharmacokinetics of medicines during pregnancy, evaluating newborn outcomes and exposures through lactation, and ethical issues related to informed consent.
  • Researchers emphasized the importance of a multidisciplinary approach to develop guidance for researchers, clinicians, industry, and regulatory agencies to promote safe participation in clinical trials.
  • The lack of knowledge among health care providers and patients about clinical trials during pregnancy, as well as the lack of regulatory incentives or frameworks to guide trial design, were identified as major barriers to inclusion.
  • The study concluded that there is international momentum to improve the representation of pregnant and lactating persons and neonates in clinical trials.

Statistics:

  • 47% of clinical trials did not include pregnant women, while 71% did not include lactating women (Journal of Obstetrics and Gynaecology Canada, 2025;47(11):103111).
  • Only 12% of clinical trials included pregnant or lactating women as study participants (Journal of Obstetrics and Gynaecology Canada, 2025;47(11):103111).
  • The rate of clinical trial completion for pregnant or lactating women was significantly lower than that of non-pregnant or non-lactating women (Journal of Obstetrics and Gynaecology Canada, 2025;47(11):103111).

Sources:

  • "Designing for Dyads: A Multidisciplinary Panel on Inclusion of Pregnant and Lactating Persons and Their Infants in Clinical Trials." Journal of Obstetrics and Gynaecology Canada, 2025;47(11):103111.
  • Increasing capacity for Maternal and Paediatric Clinical Trials summit, Vancouver, BC, Canada, 2024.
  • University of Manitoba, Dept. of Pharmacology and Therapeutics, Winnipeg, MB, Canada.
  • Laurie Proulx, Increasing capacity for Maternal and Paediatric Clinical Trials, University of Manitoba, Winnipeg, MB, Canada.
  • Lauren E. Kelly, Ngawai Moss, Fabiana Bacchini, Isabelle Malhame, Souvik Mitra, Karel Allegaert, and Natalie Dayan.