Developments in the Design, Conduct, and Reporting of Child Health Trials
Ami Baba1, Alex Aregbesola2,3, Patrina H Y Caldwell4
1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Pediatrics
|June 4, 2024
Summary
Progress in pediatric clinical trial methods is slow, despite efforts by Standards for Research (StaR) in Child Health. Emerging trends like patient engagement and adaptive designs offer future improvements for child health research.
Area of Science:
- Pediatric Clinical Trials
- Child Health Research Methods
Background:
- The Standards for Research (StaR) in Child Health network published initial standards in 2012 to improve pediatric clinical trials.
- A review of 247 publications highlighted research practices that add value and reduce waste in child health research.
Purpose of the Study:
- To assess progress in key pediatric trial methods areas.
- To identify emerging trends to enhance the clinical usefulness of pediatric trials.
Main Methods:
- Review of publications from StaR Child Health authors.
- Assessment of progress in areas including consent, bias, data monitoring, sample size, outcomes, and age groups.
- Exploration of emerging trends and implementation science approaches.
Main Results:
- Meaningful change has occurred, but measurable progress in pediatric trial methods remains slow.
- Key areas assessed include consent, bias, data monitoring, sample size, outcomes, and age groups.
Conclusions:
- Emerging trends such as patient engagement, Bayesian statistics, adaptive designs, and platform trials can advance pediatric research.
- Implementation science offers a framework for improving the design, conduct, and reporting of child health research.
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