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A response to the MHRA consultation on International Guidelines for Including Pregnant and Breastfeeding Individuals in Clinical Trials

Executive Summary

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.