Certain populations — including children — are often excluded from trials without strong clinical or scientific justification. This guidance recommends approaches that sponsors of clinical trials can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their clinical trials.
Among other recommendations, FDA suggests to consider including children (ages 2 to 11 years) and adolescents ( ages 12 to 17 years) in confirmatory clinical trials involving adults when appropriate.
It also suggest considering pediatric development program early, and staggering enrollment based on age (i.e., enrollment of older pediatric participants first, then younger pediatric participants) for pediatric trials with potential safety concerns.
Read the full text: “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs”.