A response to the MHRA consultation on international guidelines for including pregnant and breastfeeding individuals in clinical trials

Abstract

This response to the MHRA consultation on international guidelines for including pregnant and breastfeeding individuals in clinical trials strongly supports the initiative while highlighting critical gaps in current risk assessment frameworks. Drawing on University of Southampton research in maternal health policy, this submission identifies a systematic bias in clinical decision-making that undervalues the health interests of pregnant and breastfeeding individuals. The response emphasizes that when non-intervention becomes the default approach, intervention risks are overestimated while non-treatment risks are overlooked, leading to denial of appropriate care. Key recommendations include:
• Strengthening the Guidelines to explicitly incorporate non-treatment risks into risk-benefit assessments.
• Ensuring that consequences of data insufficiency are systematically considered when determining trial participation reasonableness.
• Implement this enhanced framework to better protect maternal health outcomes and ensure evidence-based policy development in this critical area.

More information

Identifiers

ORCID for Fiona Woollard: orcid.org/0000-0001-5144-3379

Catalogue record

Export record

Altmetrics