Those working in clinical trials will recall that in 2025 updates were published for the SPIRIT standard clinical trial protocol items and the CONSORT guideline for reporting randomised clinical trials. The Lancet Child & Adolescent Health will be co-publishing the first child and adolescent extensions to the SPIRIT and CONSORT reporting guidelines, along with the BMJ and JAMA Paediatrics. In this conversation with the SPIRIT and CONSORT child and adolescent project leads, Ami Baba and Martin Offringa, we discuss the need for child and adolescent specific reporting standards, the importance and value of engaging caregivers and young people in the process of developing the standards, and the potential for the SPIRIT-C and CONSORT-C reporting standards to positively impact the quality and inclusivity of paediatric clinical trials across all disciplines caring for neonates, infants, children, and adolescents.

Click here to read the full articles:

CONSORT-C https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(26)00004-0/fulltext

SPIRIT-C https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(26)00005-2/fulltext

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Ami Baba and Martin Offringa on SPIRIT-C and CONSORT-C child and adolescent extensions

The Lancet Voice