The BMJ has collaborated with JAMA Pediatrics and The Lancet Child & Adolescent Health to co-publish two papers aimed at strengthening trial conduct and reporting in order to improve the health of young patients and their families. The publications set out essential checklist items for inclusion in clinical trial protocols and reports to enhance the usefulness and impact of pediatric randomized controlled trials (RCTs).
The guidance addresses questions such as the rationale for undertaking trials involving children or adolescents, the processes for obtaining consent and protecting confidentiality, the handling of age- or development-related differences in treatment effects, and the potential impact of participation on daily life. According to the authors, the recommendations are intended to strengthen the quality and safety of the pediatric evidence base, improve health outcomes for children and adolescents, and reduce research and resource waste.
One paper introduces the CONSORT-Children and Adolescents (CONSORT-C) 2026 guideline, developed in partnership with young people, family caregivers, pediatric trialists, journal editors, and other pediatric trial stakeholders. It includes 13 additional reporting items to be used alongside the CONSORT 2025 items in pediatric RCT reports involving individuals aged 0–19 years, with the aim of facilitating comprehensive reporting and enhancing transparency, reproducibility, accuracy, and utility.
The second paper presents the SPIRIT-Children and Adolescents (SPIRIT-C) 2026 guideline, which outlines key reporting items for pediatric RCT protocols involving participants aged 0–19 years. Developed with the same stakeholder groups, it provides a checklist of 17 additional items to be reported in conjunction with the SPIRIT 2025 items, with all relevant elements aligned with CONSORT-C 2026. The authors state that inclusion of these items supports comprehensive, meaningful, relevant, and transparent reporting and can improve both the quality and usefulness of pediatric RCT protocols. Two accompanying papers explaining and elaborating on the recommendations are also published by The BMJ.
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