Newcastle contributes to international guidelines to strengthen children’s clinical trials
Thursday February 26, 2026
Children’s clinical trials remain one of the most underrepresented areas of health research, limiting the evidence available to guide care for babies, children and young people. Newcastle is helping to change that by contributing to a major international effort to improve how children’s trials are designed, reported and accessed.
Clinical trials are essential for developing safe and effective treatments. Children are historically far less likely than adults to have access to research. This gap has significant implications for children, families, clinicians and health systems, including the NHS, who rely on evidence to make decisions.
Improving children’s access to high‑quality clinical trials has become an international priority. Newcastle is playing an active role in this space in several ways, including by contributing expertise to the development of new international reporting guidelines for children’s trials.
Newcastle’s contribution is led by Niina Kolehmainen, Professor in Child Health Research at Newcastle University and Deputy Director of Newcastle Health Research Partnership Academy. The international collaboration is headed from The Hospital for Sick Children (SickKids), at Toronto, Canada by Dr. Martin Offringa.
These guidelines aim to strengthen how paediatric trials are planned, described and shared, helping to ensure that studies involving children are transparent and useful for decision‑makers. Clearer reporting also supports policymakers, healthcare professionals and families by making research findings easier to understand and apply in real‑world settings.
“Children’s trials remain an underserved area of research, despite their importance for policy, clinical practice and family decision‑making. Improving standards for how these trials are reported supports better evidence, more informed healthcare decisions, and greater confidence for families considering research participation.”
Professor Niina Kolehmainen
The work culminates in the publication of four linked papers introducing the new SPIRIT‑Children and Adolescents (SPIRIT‑C) 2026 and CONSORT‑Children and Adolescents (CONSORT‑C) 2026 guidelines.
The two Statement papers will be co‑published by The BMJ, JAMA Pediatrics, and The Lancet Child & Adolescent Health, highlighting the international importance of this work. Two accompanying Explanation and Elaboration papers will be published in The BMJ – CONSORT-C 2026 Explanation and Elaboration and SPIRIT-C 2026 Explanation and Elaboration.
The new guidelines provide essential checklist items for researchers to include when developing paediatric trial protocols and reporting trial results. They address issues that are critical in children’s research, such as the rationale for conducting trials in children and adolescents, how consent and confidentiality are managed, how developmental differences are considered and how participation may affect a child or young person’s daily life.
Newcastle’s involvement in this work reflects a broader commitment to improving research for children and young people, both nationally and internationally. By contributing to these global standards, Newcastle is helping shape best practice in paediatric research and ensuring that children’s voices and experiences are embedded in the evidence base from the outset.
Importantly, this work places Newcastle among a small number of UK contributors shaping international standards in this field. By being involved early, Newcastle is helping to influence best practice and ensure that the needs of children, families and health services are embedded from the outset.
The publication of the new guidelines is expected to gain significant attention across the research community, with strong interest anticipated from UK and European networks. NHRP will be sharing updates through its communication channels to help amplify the message and encourage widespread adoption.
“Newcastle’s contribution to these international guidelines shows the strength and maturity of our research community. By helping shape global standards, we are influencing how paediatric trials are designed and delivered for years to come – supporting better evidence, fairer access to research and ultimately better care for families.”
Professor Quentin M. Anstee,
Director of Newcastle Health Research Partnership, Pro-Vice-Chancellor of the Faculty of Medical Sciences at Newcastle University and Honorary Consultant Hepatologist at Newcastle Hospitals
Examples from Professor Kolehmainen’s CHESS trial, funded by the National Institute for Health and Care Research (NIHR), contributed to the guidelines.