Completeness of protocols for clinical trials in children submitted to ethics committees

Journal of Paediatrics and Child Health
Pathma D JosephJonathan C Craig

Abstract

Studies of published clinical trials involving children have shown frequent omissions in key aspects of design and conduct, but these problems may be artefactual and due to editorial processes and space limitations. To determine actual design and conduct, we analysed the completeness of key domains in trial protocols involving children submitted to Human Research Ethics Committees. The ethics committees of all eight children's hospitals in Australia were invited to participate. De-identified trial protocols submitted for review in 2012 were evaluated using a checklist derived from Consolidated Standards of Reporting Trials, the Cochrane Risk of Bias Tool and Good Clinical Practice guidelines. Four ethics committees agreed to participate, and 69 protocols were analysed. The domains almost always reported were clustered around the background and trial plan (planned interventions for each group (99%), specific objectives (97%) and scientific background (96%)). Risk-of-bias domains such as random sequence generation and blinding of participants were often reported (75-90%). Domains least reported were clustered around the statistical analysis plan (66%), specified intention-to-treat analysis (54%), the justification for the propose...Continue Reading

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Citations

Oct 22, 2020·Journal of Paediatrics and Child Health·Richard G McGee, Amanda C Dawson
Feb 27, 2021·The Journal of Pathology. Clinical Research·Shujing Jane LimMax Robinson
Oct 27, 2021·Journal of the Royal Society of Medicine·Iain Chalmers, Paul Glasziou

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