TABLE 3

Research Agenda

AimMethods
• Gather existing age group guidance• From national and international agencies, as well as from literature about biological, developmental, psychological, and social changes with age
• Seek consensus• Use a Delphi process to reach consensus about suitable age groups to be adopted for international use if pediatric trials
• Assess the utility of our suggested schema for considering the likely impact of age group differences on trial design• Recruit trialists to use the schema and report on its ease of use and whether it influenced decision-making about age groups for their planned trial
• Explore the effect of age groups on outcome for a range of conditions and interventions• We will explore the presence, prevalence, and magnitude of age-treatment effect interactions in a large number of clinical conditions and interventions
• Assess the impact of consistent age groups for data synthesis in pediatric topics• We will review pediatric systematic reviews that currently exist and quantify the extent to which inconsistent age groups have contributed to an inability to synthesize data or develop clinically meaningful recommendations
• Catalog and update validated predictive models for treatment outcome interactions• Catalog and keep updated appraisals of the evidence regarding multivariate predictive models for treatment outcome interactions that have been well validated and have adequate discriminatory performance that may improve the design and analysis of clinical trials