The information collected in high-quality clinical trials must provide reliable evidence to effectively advance health care in 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-C (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-C guidelines and to ensure endorsement. By standardizing how researchers conduct trials in children, the SPIRIT-C guidelines may improve the safety, use and impact of clinical research.
The evidence synthesis, Delphi survey and international consensus have been completed. The checklists have been finalized (available on request). CONSORT-C and SPIRIT-C statements and Explanation and Elaboration documents will be published May 2016.
Details from the systematic review can be found here: Clyburne-Sherin AVP, Thurairajah P, Kapadia M.Z, Sampson M, Chan WWY, Offringa M (2015). Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews – BMC Trials, 16: 417.