CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials

The CONSORT-Children and Adolescents (CONSORT-C) Extension provides a framework to improve the completeness, transparency and impact of reports from randomised clinical trials involving children and adolescents. It extends the CONSORT reporting recommendations by incorporating considerations specific to paediatric research, recognising that trials conducted in children require additional attention to developmental stages, participant characteristics, outcomes and interpretation of findings.

The tool supports researchers, authors and reviewers in ensuring that paediatric clinical trial results are reported in a way that allows appropriate evaluation of methodological quality, clinical relevance and applicability. By promoting consistent reporting of trial methods, participant populations, interventions, outcomes and results, CONSORT-C facilitates clearer communication of evidence and improves the reproducibility and usefulness of paediatric clinical research.

This resource is particularly relevant for rare disease clinical trials because many rare diseases have childhood onset and clinical evidence is often generated from small, complex and highly specialised studies. In these settings, every trial contributes substantially to the available evidence base, and incomplete reporting can significantly limit the ability to interpret findings, compare studies or perform evidence synthesis.

For paediatric rare disease research, transparent reporting is essential not only for scientific dissemination but also for supporting regulatory assessment, clinical decision-making and future research planning. Clear reporting of outcomes, safety findings and participant characteristics can help ensure that knowledge generated from small populations is fully captured and accessible to researchers, healthcare professionals and patient communities.

CONSORT-C complements other rare disease trial resources such as SPIRIT-C for protocol development, outcome selection frameworks and reporting guidance for specific innovative trial designs. Together, these tools support a complete lifecycle approach to improving the quality, transparency and impact of paediatric rare disease clinical trials.

Although focused on paediatric randomised trials, the principles are broadly applicable to rare disease research where maximising the value of limited clinical evidence is a key priority.