Global Guidelines for Paediatric Trials Developed with TEDDY Expertise
TEDDY is proud to announce the involvement in the preparation of major guidelines aimed at improving the design, and reporting of paediatric clinical trials.
The SPIRIT-Children and Adolescents (SPIRIT-C) 2026 and CONSORT-Children and Adolescents (CONSORT-C) 2026 guideline papers have been published alongside their statement papers. They were co-published in the BMJ, JAMA Pediatrics, and The Lancet Child & Adolescent Health, with accompanying Explanation and Elaboration papers published in the BMJ.
The content has been developed by an international team of experts, including Giorgio Reggiardo, Chair of the TEDDY Working Group on Paediatric Research Methodologies and a member of the TEDDY Board of Directors, representing the TEDDY Network in this global initiative.
The published papers can be accessed via the following links:
🗒️ Enhancing the reporting and impact of paediatric randomised trials: CONSORT-Children and Adolescents (CONSORT-C) 2026 extension
https://www.bmj.com/content/392/bmj-2025-085061
🗒️ Enhancing the reporting and usefulness of paediatric randomised trial protocols: SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension
https://www.bmj.com/content/392/bmj-2025-085062
🗒️ CONSORT-C 2026 Explanation and Elaboration: Recommendations for enhancing the reporting and impact of paediatric randomised trials
https://www.bmj.com/content/392/bmj-2025-085063
🗒️ SPIRIT-C 2026 Explanation and Elaboration: Recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols
https://www.bmj.com/content/392/bmj-2025-085064
The new guidelines introduce paediatric-specific standards for randomised controlled trial protocols and reports involving children and adolescents aged 0-19 years. They address key issues such as the rationale for conducting trials in children, age-appropriate consent and assent, developmental differences in treatment effects, and the impact of trial participation on children’s daily lives.
Developed in collaboration with paediatric trialists, methodologists, journal editors, young people, and family caregivers, these publications aim to strengthen the paediatric evidence base, improve research transparency and quality, and reduce research waste.
TEDDY’s involvement in this publication highlights its ongoing commitment to advancing high-quality paediatric clinical research, promoting rigorous trial methodology, and ensuring that studies meaningfully improve health outcomes for children and adolescents.
You can find more information on TEDDY Publications at the following LINK.