SPIRIT-C 2026 & CONSORT-C 2026: New guidelines for pediatric clinical trials
With the release of the SPIRIT-C 2026 and CONSORT-C 2026 Extensions, researchers now have reporting guidelines created specifically for pediatric clinical trials. This marks a shift toward research that is fundamentally centred on children and their families, generating more transparent and more relevant trial reports.
For Martin Offringa, a pediatrician at The Hospital for Sick Children (SickKids), a professor at the University of Toronto, a MICYRN Clinical Trial Consortium Member, and our RareKids-CAN Methods & Design Sub-Platform lead, the need for a change has been clear for years. He chaired the SPIRIT | CONSORT-C initiative. As he told The Lancet: “More trials have been done over the last ten years, but we have struggled with transparency and clarity, and sometimes with the quality because they are not always asking the questions and measuring the outcomes that are relevant for the children and their families.”
Why pediatric trials need their own standards
Pediatric trials have often adapted frameworks designed for adults, despite the fact that children’s developing anatomy, physiology, pharmacology, psychology and lived experiences introduce different considerations at different ages. From drug dosing and safety to recruitment challenges and research ethics aspects, pediatric trials require a different lens. And until now, there was no dedicated standard to guide how those trials should be designed and reported.
The SPIRIT-C and CONSORT-C extensions change that. They establish a structured framework for both trial protocols and reporting, helping ensure that studies are not only methodologically sound, but also generate meaningful information for the children and families impacted by a trial’s results. Without this structure, important data can be missed, and trial reports can lack nuance and relevance.
The guidelines were developed with the input of many faculties, clinicians, and trialists affiliated with MICYRN member institutions; this is an example of an outstanding collective achievement, bringing together expertise from multiple institutions dedicated to improving and enhancing child health research.
Co-designed with children and families
What sets these new guidelines apart is that children and their families were directly involved in defining what data should be prioritized, collected, and reported. Youth advisory groups and family caregiver groups worked alongside researchers across five countries, contributing through workshops, consultations, and consensus-building exercises. Young people were asked not just to react to ideas, but to help generate them. As Dr. Offringa noted in a Lancet feature, “We’ve had some tangible input that wasn’t there from the literature… this was uniquely generated by the kids.”
That input is now embedded directly into the guidelines. SPIRIT-C introduces 17 new reporting items, while CONSORT-C adds 13, several of which are rooted in priorities identified by young people and caregivers themselves.
Improving the trial experience for children
The guidelines also have the potential to reshape the experience of participating in a clinical trial. Researchers are encouraged to apply the reporting criteria early so they take the right safety measures, collect the right data, ask the right questions, and focus on outcomes that matter to patients and families. As a onsequence, trials designed with SPIRIT-C and CONSORT-C in mind are more likely to centre the needs of children and make participation safer, clearer, and less overwhelming. For families, that can mean more relevant outcomes, better information, and greater confidence in decision-making. For researchers and clinicians, it means generating data that is more useful, more applicable, and more likely to improve care.
Driving adoption
The challenge now is adoption, and this is where MICYRN plays a key role.
As a national network connecting researchers, clinicians, and patient partners across Canada, MICYRN is well positioned to accelerate awareness and uptake of SPIRIT-C and CONSORT-C through targeted dissemination and knowledge mobilization efforts.
From sharing resources across its network to convening discussions, MICYRN will help ensure these guidelines reach the people who design, fund, and deliver pediatric trials. Just as importantly, network leadership will reinforce expectations for adoption — supporting a broader shift toward consistent, child-centred research practices.
Full details about SPIRIT-C and CONSORT-C guidelines can be found here.