New Global Standards for Pediatric Clinical Trials Include Items Written by Children Themselves

Clinical trial reporting standards have long been designed by adults, for trials assumed to involve adults. When those standards are applied to pediatric trials - studies in newborns, infants, children, and adolescents - they routinely miss details that matter: how consent is obtained from children too young to sign documents, whether outcomes are developmentally appropriate for the age group studied, how families are involved in care decisions during the trial, and whether the trial design accounts for the fact that a 6-month-old and a 16-year-old respond to treatments very differently.

Two new sets of reporting guidelines, published simultaneously in The BMJ, JAMA Pediatrics, and The Lancet Child and Adolescent Health, address that gap. SPIRIT-Children and Adolescents (SPIRIT-C) 2026 covers trial protocols; CONSORT-Children and Adolescents (CONSORT-C) 2026 covers completed trial reports. Together they establish the first global pediatric-specific reporting standard, and they were built with a methodological element unusual in guidelines development: young people themselves wrote some of the checklist items.

What the guidelines add

SPIRIT-C adds 17 new items to the existing SPIRIT 2025 protocol reporting standard. CONSORT-C adds 13 new items to CONSORT 2025. The new items address pediatric-specific realities that adult-focused standards do not capture. These include consent and assent processes - the legal and ethical distinction between parental consent and a child's own agreement to participate; age-appropriate outcome measures and intervention delivery; developmental considerations across the 0-19 age range; and the role of families in trial conduct.

"Recent research into developmental biology clearly shows how children are not one single, homogeneous group. An intervention can work very differently at different ages and stages of development," said Dr. Martin Offringa, Senior Scientist in Child Health Evaluative Sciences at SickKids and chair of the guideline development group. "SPIRIT-C and CONSORT-C provide a practical playbook to help researchers present their trial protocols and final findings in ways that reflect the realities of paediatric care and development."

Youth involvement as a methodological feature

Four of the 17 SPIRIT-C items and one of the 13 CONSORT-C items were generated by young people through a series of workshops. Six SPIRIT-C items and six CONSORT-C items were youth-endorsed, meaning young participants reviewed and validated them. This level of patient involvement in developing the guidelines themselves - not just consulting young people about trial experience but having them contribute to the technical checklist - is described by the development team as unprecedented in reporting guidelines.

The workshops involved 42 young people aged 10 to 21 across five countries: Canada, England, France, Scotland, and Spain. Canadian youth advisors aged 13 to 19 also participated in pan-Canadian advisory groups, working alongside family caregiver advisors to shape how the guidelines would handle consent, outcome selection, and result communication.

"This is the first time trial reporting guidelines have integrated child and youth-focused considerations, including items generated and endorsed by young people themselves," said first author Ami Baba, Senior Project Manager in the EnRICH Research Group at SickKids. "Considering that children, young people and families are end-users of trial protocols and reports, including their perspectives was critical for developing relevant and useful guidelines."

The problem the guidelines address

Pediatric randomized controlled trials are the primary basis for deciding how children are treated medically. But the reporting quality of those trials has historically been poor. Incomplete reporting makes it difficult to assess whether a trial was conducted rigorously, whether its results are applicable to specific patient groups, and whether its findings can be combined with other studies in meta-analyses. Poor reporting also makes it hard for families and clinicians to assess what a trial actually showed.

When adult reporting standards are applied uncritically to pediatric trials, the result is often reports that describe age ranges too broadly, omit information about developmental considerations, fail to specify how consent was obtained from different age groups, and do not report outcomes that matter to children and families. The new guidelines directly require researchers to address each of these gaps.

Implementation and limitations

The research team plans to track guideline uptake by assessing how many journals endorse and enforce the guidelines within 12 months of publication. The guidelines are accompanied by two explanation papers in The BMJ providing detailed guidance on applying the new items in practice.

The team acknowledges that future updates should involve broader participation from researchers and young people in low- and middle-income settings, where the majority of the world's children live and where trial conditions and cultural contexts differ substantially from the primarily high-income countries represented in the development process.

Funding came from the Canadian Institutes of Health Research, Ontario Child Health Support Unit, and CIHR Strategy for Patient-Oriented Research.