TABLE 1

Schema for Considering the Likely Impact of Age Group Differences on Trial Design

FeatureBiologicalaDevelopmentalbPsychologicalSocial Context and Expectations
Type of intervention (eg, dose, delivery)
Type or measurement of positive effects
Type or measurement of harms and adverse effects
Comparator (eg, type, dose, delivery)
Duration of follow-up
  • Place a tick in any cell indicating known or hypothesized differences for biological, developmental, psychological, or social context across the age range of childhood that may affect the choice of optimal study design features. If any cell is ticked, then careful consideration of age groups for inclusion or analyses is warranted.

  • a Including physiologic, immunologic, and puberty and reproduction factors.

  • b Including educational setting.