TABLE 4

Recommendations for Practice

• Consider the use of appropriate age range in the eligibility criteria, age-related stratification, and age-related analysis plans during the design phase of every pediatric trial
• Consider the use of age groupings outlined by the Eunice Kennedy Shriver National Institute of Child Health and Human Development
 • Use smaller or wider age ranges when appropriate and justify reasons for doing so
 • Detail whether use of smaller or wider age ranges was decided a priori
• Ensure biological, developmental, psychological, and social variables are appropriate for trial design for included ages
• Consider use of full well-validated and well-performing multivariate predictive models for risk stratification and evaluation of risk–treatment interactions in conditions for which these exist
• If individual patient data are available for systematic reviews, then the tailoring of age group–based analysis for optimal assessment of ideal age groups, interactions with other factors, and age–treatment interactions may be possible