The World Health Organization (WHO) has published a technical report establishing a global research agenda for paediatric clinical trials targeting children aged up to nine years.
Titled ‘The future of paediatric clinical trials – setting research priorities for child health’, the report aims to direct investment and facilitate coordinated efforts in generating evidence.
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The agenda addresses critical evidence gaps that inform programmes, policies and clinical guidelines for child health, following WHO’s 2024 guidance emphasising inclusion of under-represented subjects in trials.
Despite substantial child health improvements over two decades, progress remains inequitable, with preventable illnesses causing significant mortality and morbidity in middle-and low- income countries.
Children continue to be underrepresented in clinical trials, creating evidence gaps that directly affect their specific needs.
The research agenda outlines priority questions that clinical trials can address, aiming to generate significant public health benefits and enhance outcomes for at-risk children.
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By GlobalDataIt was developed through a comprehensive consultation process involving more than 380 global stakeholders, who contributed a total of 653 research questions.
An expert review and prioritisation process subsequently identified 172 clinical research priorities, covering areas such as non-communicable and infectious diseases, nutrition, newborn health, and early childhood development.
WHO Department of Science for Health director Dr Meg Doherty said: “This research agenda offers governments, partners and research institutions a clear direction for investment.
“By identifying where evidence is most needed, it creates an opportunity to coordinate resources and foster collaboration to address the highest-burden areas affecting children today.”
The report emphasises the importance of strengthening institutional capacities for multi-country studies, research integration within national health systems, coordinated financing strategies, and regional collaboration.
WHO will support the implementation of these initiatives, foster dialogue, and mobilise resources for priority research working in collaboration with Member States and partners.
In September 2025, major medical research funders endorsed a statement pledging to adopt WHO standards to strengthen trial systems and better serve communities and patients worldwide.
