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

There is international momentum to improve the representation of pregnant and lactating persons and neonates in clinical trials to generate equitable and robust data for these groups. Appropriate inclusion of these groups in clinical trials requires additional considerations owing to alterations in pharmacokinetics of medicines during pregnancy, evaluating newborn outcomes and exposures through lactation, ethical issues relating to the timing of and approach to informed consent, and a lack of regulatory incentives or frameworks to guide trial design. These factors, combined with low overall knowledge of clinical trials, make it challenging to engage health care providers and patients in discussions about clinical trials during pregnancy. A multidisciplinary approach is needed to develop guidance for researchers, clinicians, industry, and regulatory agencies to promote safe participation. We herein provide a summary of the discussion from a multidisciplinary panel entitled "Designing for Dyads" that was held at the 2024 Increasing capacity for Maternal and Paediatric Clinical Trials summit in Vancouver, BC, Canada and the action items suggested by the panel.