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The need for the PIPELINE project has never been more urgent. Recent pandemics have highlighted significant gaps in clinical research involving pregnant people and infants, often leaving them underrepresented in trials. This results in unacceptable delays in the generation of evidence on the effectiveness and safety of interventions in these populations. The PIPELINE project aims to address these challenges by establishing a robust and sustainable platform for adaptive clinical studies, which allow for ongoing adjustments to the trial design based on emerging data. This flexibility ensures that research remains relevant and responsive as new information becomes available.
A key component of the PIPELINE initiative is its proof-of-concept trial focusing on respiratory syncytial virus (RSV) immunisation in pregnant people and infants. This adaptive platform trial will address a critical public health priority for the EU, as RSV is a leading cause of respiratory illness in young children. By evaluating the safety and efficacy of immunisation strategies, the PIPELINE RSV trial aims to generate vital evidence that can inform clinical practices and public health policies, ultimately reducing the burden of RSV-related morbidity and mortality in infants.
“PIPELINE represents a significant step forward in advancing our understanding of how to protect and treat pregnant people and infants during health crises,” said Prof. Carlo Giaquinto, PIPELINE Coordinator at Fondazione Penta ETS and Professor of Paediatrics at the University of Padova, Italy. “By fostering collaboration across Europe, we can leverage diverse expertise and resources to develop innovative solutions that will benefit these underserved populations.”
This trial marks a notable collaboration with the ANRS-MIE (French research agency on infectious and emerging diseases) and will be conducted concurrently in France under the coordination of the Université Paris Cité and the sponsorship of Annecy Hospital. This initiative exemplifies the Consortium dedication to cultivating valuable partnerships. By joining forces, PIPELINE aims to achieve significant outcomes that benefit public health and set the stage for future collaborative research.
The PIPELINE platform will utilise cutting-edge methodologies and an interdisciplinary approach, including observational studies, social sciences and health economic evaluation. To ensure a rapid and effective response to emerging health threats and the long-term utilisation of the project infrastructure, PIPELINE will establish a pioneering network of clinical trial sites specifically trained in conducting research involving pregnant people and infants. By bringing together experts of diverse disciplines and utilising the infrastructure of existing networks like Penta, Ecraid, VACCELERATE, and c4c, PIPELINE will create a ‘warm’ and responsive research ecosystem, ready to activate and conduct high-quality studies in pregnant people and infants.
“Our ambition is not only to conduct specific adaptive trials focusing on prevention and/or treatment of emerging infections in pregnancy and early life, but also to offer a resource (toolkit and network) for external trialists and networks to increase the participation of pregnant individuals in adult trials”, stated Claire Thorne, PIPELINE Scientific Co-coordinator, Professor of Infectious Disease Epidemiology at University College London and Fondazione Penta ETS Vice President.
Furthermore, PIPELINE recognises the importance of capacity strengthening. “By empowering the trial sites in our network with proper training in the conduct of adaptive clinical trials, we can lead the way in innovative research in underserved populations, such as pregnant people and infants, said Patricia Bruijning-Verhagen, PIPELINE Network activities Lead and Paediatrician and Epidemiologist at UMCU Utrecht. The project will implement training programs to equip healthcare professionals and researchers with the necessary skills to conduct high-quality adaptive clinical trials in this vulnerable population.
The broader long-term contribution of the PIPELINE project extends beyond immediate research outcomes. By establishing a sustainable framework for maternal and infant health research, the project aims to influence policy, improve clinical practices, and enhance public health strategies across Europe. This initiative will not only address current health challenges but also prepare the healthcare system for future pandemics and health emergencies.
"The PIPELINE Consortium envisions a future where this network can serve as a foundation for global collaboration, ensuring that pregnant people and infants receive the best possible care, regardless of their location," said Ali Judd, PIPELINE scientific co-coordinator at Fondazione Penta ETS and Professor of Epidemiology at University College London.
The PIPELINE project is poised to make a lasting impact on maternal and infant health, setting a new standard for clinical research in Europe and beyond.
Led By Fondazione Penta ETS - Penta, the PIPELINE Consortium consists of 16 partners who are internationally known for their contribution to maternal and child health research. It includes: St George's Hospital Medical School, University Medical Center Utrecht, University College London, University of Rome Tor Vergata, University of Antwerpen, Institut National Sante Et De La Recherche Medicale, conect4children Stichting, ISI Foundation, Servecio Madridelian de Salud, Ecraid, University of Verona, ReSViNET, Université Paris Cité, Annecy Genevois Hospital Centre, and School of Advanced Studies in Public Health.
The PIPELINE project is funded by the European Union. Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.
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Penta is an international independent scientific network dedicated to advancing child health research. With a focus on improving prevention, diagnosis, and treatment of infections in children, Penta builds a global network to support health systems in achieving optimal outcomes for children and pregnant people. To date, Penta has sponsored over 50 clinical studies in various infectious diseases, involving over 50,000 children and pregnant people.
Francesca Mazzetto
Penta Foundation ETS
+39 348 615 1202
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