We are excited to share that EPTRI has been involved in the preparation of the SPIRIT-Children and Adolescents (SPIRIT-C) 2026 and CONSORT-Children and Adolescents (CONSORT-C) 2026 guideline papers that will be available next Tuesday 24 February 2026 at 23:30 GMT.
The two papers, prepared closely with young people, family caregivers, and other paediatric trial interest holders including paediatric trialists and journal editors, provide a combined check list of 30 items intended for paediatric randomised controlled trials (RCT) reports involving children and adolescents aged 0-19 years, thus enhancing the usefulness, and impact of paediatric RCT.
The papers, tailored specifically to the specific needs of children and their families will change the landscape of paediatric randomised controlled trials (RCT) by:
- Improving complete and transparent reporting,
- Reducing bias and increasing trial reliability,
- Standardizing and harmonizing reporting,
- Assisting clinicians and families to apply evidence more safely and effectively,
- Supporting reproducibility and open science
To increase the impact of this research, the two papers will be published in The BMJ, JAMA Pediatrics, and The Lancet Child and Adolescent Health, while two accompanying papers, explaining and elaborating on these new recommendation’s papers will be published in The BMJ only.
Both papers, as well as the two accompanying papers are available below:
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
At EPTRI, we are committed to advance preclinical and clinical paediatric research to provide the best drugs, therapies, medical devices and health data solutions to the paediatric population.
This is a big step forward to providing the best clinical research to this underserved population.