Pregnant and Breastfeeding Women Urged for Inclusion in Clinical Trials to Close Evidence Gaps

The Stark Numbers

You’re pregnant and need medication – but chances are, that drug has never been properly tested on someone in your condition. New analysis reveals pregnant women were included in just 1.1% of trials submitted for regulatory approval between 2019 and 2023. For breastfeeding women, it’s even worse at 0.6%.

The European Medicines Agency’s Clinical Trials Information System shows less than 0.4% of trials currently submitted in the EU include pregnant people. That figure drops to a shocking 0.1% for those who are breastfeeding.

A Legacy of Fear

This exclusion isn’t accidental. It stems from the thalidomide tragedy and diethylstilbestrol scandals of decades past, when pregnancy became viewed primarily through a risk-management lens rather than considering the evidence gaps this creates.

But the landscape is changing. Both the European Medicines Agency and US Food and Drug Administration have now adopted guidelines to support ethical inclusion of pregnant and breastfeeding women in clinical trials. The World Health Organization has joined this push, recognising that exclusion often causes more harm than carefully managed participation.

Why It Matters Now

Pregnancy and breastfeeding fundamentally alter how the body processes medications. These physiological changes affect drug absorption, distribution, and elimination – yet without trial data, doctors are prescribing “off-label” based on educated guesswork rather than evidence.

The reasons for historical exclusion remain powerful: perceived risks to the foetus, complex ethical considerations, liability concerns, and frankly, low commercial incentives for pharmaceutical companies. Yet this leaves women as what researchers call “therapeutic orphans” – forced to choose between untested treatments or forgoing needed care entirely.

Research suggests many pregnant women would actually participate in trials if properly informed about the risks and benefits. The choice, as medical experts now frame it, is no longer between protection and participation, but between managed risk with evidence and unmanaged risk without it.

Recent initiatives are beginning to address these gaps through collaborative research networks, post-marketing registries, and new regulatory frameworks designed to generate safety data ethically.

Key Takeaways

• Only 1.1% of recent clinical trials included pregnant women, with breastfeeding women in just 0.6%
• Historical exclusion from research creates dangerous evidence gaps in medication safety
• New regulatory guidelines from EMA and FDA support ethical inclusion of pregnant and breastfeeding women in trials

What This Means for Kent Residents

Pregnant and breastfeeding women across Kent face the same evidence gaps when seeking treatment through local NHS trusts like East Kent Hospitals University NHS Foundation Trust and Maidstone and Tunbridge Wells NHS Trust. While these hospitals conduct clinical trials, they rarely include expectant or nursing mothers, perpetuating the cycle of uncertainty. If you’re pregnant or breastfeeding and have concerns about medication safety, contact NHS 111 or speak with your maternity team – though be aware that limited trial data may restrict the evidence-based options available to you.