Historically, pregnant individuals and infants have been routinely excluded from clinical research under the guise of protection. The PIPELINE project serves as a critical response to this systemic gap, reframing inclusion not as an ethical hurdle, but as the cornerstone of pandemic preparedness.
As highlighted by recent global health emergencies, exclusion is a risk. When we lack data for these specific populations, we force clinicians to make blind treatment decisions, leaving the most vulnerable exposed to untested interventions or denied life-saving care. PIPELINE shifts the paradigm from protecting people from research to protecting them through responsible research. By ensuring the inclusion of pregnant people and infants in research frameworks from the outset, we mitigate the risk of delayed evidence and ensure that medical countermeasures are safe and effective for everyone.
Central to this vision is the establishment of a pregnancy-infant preparedness platform for adaptive trials. Rather than launching one-off trials that may dismantle after a crisis, PIPELINE aims to develop a warm-base of research sites ever ready to activate and pivot rapidly when a new threat emerges without the delays of traditional trial setup.
In the PIPELINE framework, equity and inclusion are foundational design principles, not afterthoughts. By addressing the most complex physiological and ethical considerations upfront, we strengthen the resilience of the entire health system. Ultimately, meaningful preparedness is found in science that protects through inclusion, ensuring that our response to future crises is proactive, evidence-based, and serves all populations equitably.
“Penta has spent over 30 years building a global community dedicated to ensuring that pregnant and paediatric populations aren’t left behind in medical research: coordinating PIPELINE feels like the natural culmination of that journey. I’m proud to be managing a project committed to advancing meaningful representation of pregnant people, infants and children in research as a core component of pandemic preparedness.” – Francesca Viero, PIPELINE project manager