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Designing for Dyads: A Multidisciplinary Panel on Inclusion of Pregnant and Lactating Persons and Their Infants in

Lauren E Kelly1, Laurie Proulx1, Ngawai Moss1

  • 1Increasing capacity for Maternal and Paediatric Clinical Trials, Department of Pharmacology and Therapeutics, University of Manitoba, Winnipeg, MB.

Journal of Obstetrics and Gynaecology Canada : JOGC = Journal D'Obstetrique Et Gynecologie Du Canada : JOGC
|September 12, 2025
PubMed

Insights

Improving clinical trial representation for pregnant individuals and neonates requires addressing pharmacokinetic changes, ethical considerations, and regulatory gaps. A multidisciplinary approach is essential for developing guidance to ensure safe participation.

Area of Science:

  • Clinical Trials
  • Maternal and Child Health
  • Pharmacokinetics

Background:

  • International efforts are underway to enhance the inclusion of pregnant and lactating individuals and neonates in clinical trials.
  • Current challenges include altered pharmacokinetics during pregnancy, evaluating neonatal outcomes, ethical consent processes, and a lack of regulatory guidance.
  • Limited knowledge about clinical trials hinders engagement among healthcare providers and patients.

Purpose of the Study:

  • To summarize discussions from the "Designing for Dyads" panel at the 2024 Increasing capacity for Maternal and Paediatric Clinical Trials summit.
  • To identify action items for improving the inclusion of pregnant and lactating individuals and neonates in clinical trials.

Main Methods:

  • A multidisciplinary panel discussion was held.
  • Key challenges and considerations for trial design were identified and summarized.

Main Results:

  • The panel highlighted the need for a coordinated, multidisciplinary approach involving researchers, clinicians, industry, and regulatory agencies.
  • Specific action items were suggested to overcome barriers to participation.

Conclusions:

  • Developing comprehensive guidance is crucial for researchers, clinicians, and regulatory bodies to promote the safe and effective participation of pregnant and lactating individuals and neonates in clinical trials.
  • A collaborative effort is necessary to generate equitable and robust data for these vulnerable populations.

Keywords:
clinical trialsobstetricsrandomisedwomen’s healthworkshop proceeding

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