Guidelines set new playbook for pediatric clinical trial reporting

(Press-News.org) Researchers at The Hospital for Sick Children (SickKids), working with international collaborators and youth and family caregivers, have developed a child- and youth-centred global standard for reporting paediatric randomized controlled trials (RCTs) protocols and final reports.

Co-published today in The BMJ, JAMA Pediatrics and The Lancet Child & Adolescent Health, the SPIRIT-Children and Adolescents (SPIRIT-C) 2026 and CONSORT-Children and Adolescents (CONSORT-C) 2026 guidelines introduce new recommendations to improve the quality, transparency and usefulness of paediatric RCT protocols and final reports. Together, they aim to ensure that paediatric clinical research is comprehensively reported and includes details that young people and their families consider important. The new guidance promotes consistency, to make it easier to interpret, compare, and apply study findings in care.

Led at SickKids by Ami Baba and Dr. Martin Offringa, and coauthored with 38 international experts, the guidelines reflect global expertise and provide essential checklist items for researchers to include in clinical trial protocols and reports.

“Paediatric trials generate evidence that directly shapes how children are treated around the world,” says first author Baba, a Senior Project Manager in the EnRICH Research Group and Network at SickKids. “This is the first time trial reporting guidelines have integrated child and youth-focused considerations, including items generated and endorsed by young people themselves. 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.”

Why paediatric-specific guidance matters RCTs are widely considered the gold standard for evaluating the effectiveness of health interventions; however, many trial standards have historically been developed with adult populations in mind. SPIRIT-C 2026 and CONSORT-C 2026 address this gap by outlining paediatric specific considerations such as age-appropriate trial outcomes and intervention delivery, consent and assent processes, family involvement, and accounting for developmental needs.

They are an extension of existing internationally recognized SPIRIT and CONSORT 2025 statements, each addressing a unique stage of the trial lifecycle for newborns, infants, children, and adolescents (ages 0-19): 

SPIRIT-C 2026 Extension: focuses on reporting trial protocols, adding 17 new items for paediatric RCTs in addition to the SPIRIT 2025 items. Four items are youth-generated and six youth-endorsed.  CONSORT-C 2026 Extension: focuses on reporting completed RCTs, introducing 13 new items to improve clarity and completeness of results reported in addition to the CONSORT 2025 items. One item is youth-generated and six youth-endorsed.  “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. 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,” says Offringa, Senior Scientist in Child Health Evaluative Sciences and chair of the guideline development group. “Getting this right from the start will lead to clearer evidence, less research waste, and findings that can be meaningfully applied in real-world care.”

Built with patients and families  A defining feature of both guidelines is their co-development with young people and family caregivers, who contributed lived-experience perspectives throughout the multi-year process.

In Canada, pan-Canadian youth (ages 13-19) and family caregiver advisory groups were involved across all project stages. A dedicated Youth Advisory Group advised the research team on how to engage young people in workshops, so they could share what information they would want to see reported in a trial protocol or report. The Family Caregiver Advisory Group supported how to involve caregivers throughout the different project stages, including a Delphi study, consensus meetings, pilot testing and project dissemination. Their input directly shaped the guidelines, as well as accompanying educational resources.

Internationally, 42 young people aged 10 to 21 contributed to the development of trial reporting items through a series of workshops held in Canada, England, France, Scotland and Spain. A case study describing this engagement approach was published in Research Involvement and Engagement in 2025. 

Maureen Smith, a patient partner with lived experience who led the patient engagement strategy for the reporting guidelines, notes: “Our Canadian youth advisors were instrumental in co-designing workshops that enabled meaningful engagement with young people across five countries in complex methodological work. Young people shared their perspectives on what information matters most to them when trial protocols and results are reported — information they may rely on to make decisions about their health. Such involvement of youth perspectives is yet unseen in reporting guidelines."

Advancing precision and partnership in paediatric research  Two accompanying explanation papers on trial protocols and final trial reports published today in The BMJ provide additional detail on how the new recommendations can be applied in practice. 

Together, the work offers a comprehensive framework to strengthen paediatric clinical research, improve transparency and reproducibility, and reduce research waste. These publications build on more than a decade of effort by the EnRICH team to strengthen clinical trial methodology and reporting.

It also reflects a growing focus on partnership-driven research in support of Precision Child Health, a movement at SickKids to individualize care for each unique child. As care becomes more tailored, the research that informs it must also evolve, say the authors.

The research team hopes the guidelines will influence journal policies, research ethics boards, funders, and trial registries worldwide, and further stimulate youth engagement in methodological research. They also note that future updates would benefit from broader involvement of participants from low- and middle-income settings to ensure paediatric trials reflect diverse contexts and lived experiences, and plan to track uptake by assessing how many journals endorse and enforce the guidelines in the 12 months after publication.

“Trials often focus on the intervention, like a new drug or procedure, but then the question becomes: how do the key interest holders define treatment success, and for whom? Who is choosing the all-important trial outcomes and what role do patients and caregivers play in defining 'meaningful’ change? Better designed and better reported studies mean less wasted effort yielding evidence that can directly improve outcomes for children and families,” adds Offringa.

This research was funded by the Canadian Institutes of Health Research (CIHR), Ontario Child Health Support Unit, and CIHR Strategy for Patient-Oriented Research.

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