The information collected in high quality clinical trials must provide reliable evidence to effectively advance health care for children. A well-written protocol facilitates an appropriate assessment of scientific, ethical and safety issues before a trial begins. In addition, the critical appraisal of the consistency and rigour of trial conduct and final results is enhanced.
The Canadian-led SPIRIT (Standard Protocol Items for Randomized Trials) initiative has recently produced guidelines that outline important items that should be addressed in study protocols, with the aim of improving the quality of protocols and enabling accurate interpretation of trial results. Trials in young children require additional and modified standards to cover the complexity associated with trials in the paediatric population. SPIRIT-Children will be an extension of the SPIRIT 2013 checklist for clinical trials in the paediatric population.
This study will (a) seek consensus regarding the minimum items required in a children’s trial protocol, (b) develop a plan of research to develop guidelines for researchers on how to implement checklist items, and (c) plan a knowledge translation strategy to disseminate the SPIRIT-Children guidelines and to ensure endorsement. By standardizing how researchers conduct trials in children, the SPIRIT-Children guidelines may improve the safety, use and impact of clinical research.
Current status
An international advisory group has been assembled. Youth workshops have been conducted in Canada, England, Spain, France, and Scotland. The Delphi Study launched in January 2024 and is currently ongoing. The registration for the development of SPIRIT-C can be found here.
Publications
Systematic review: Clyburne-Sherin AV, Thurairajah P, Kapadia MZ, Sampson M, Chan WW, Offringa M. Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews. Trials. 2015 Sep 18;16:417. doi: 10.1186/s13063-015-0954-0. PMID: 26385379; PMCID: PMC4574457.
Viewpoint: Baba A, Offringa M. Transparent Reporting-SPIRIT-C/CONSORT-C Pediatric Updates. JAMA Pediatr. 2023 Dec 26. doi: 10.1001/jamapediatrics.2023.5740. Epub ahead of print. PMID: 38147343.
Protocol: Baba A, Smith M, Potter BK, Chan AW, Moher D, Offringa M. Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children. Trials. 2024 Jan 30;25(1):96. doi: 10.1186/s13063-024-07948-7. PMID: 38287439.
Updated January 2024
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