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The problem
Intervention: Best Pharmaceuticals for Children Act (BPCA) - legislation providing FDA authority to solicit drug sponsors to conduct pediatric studies, with incentives of additional market exclusivity and pediatric information
Who it was tested with: Clinical trials for 22 drugs that received BPCA marketing exclusivity from 2016-2018 in the United States.
Experience from people who deliver programmes: stories, case studies and lessons learned. Valuable for understanding how and why, and for spotting what to test next, but not a measure of effect.
"CTs that received marketing exclusivity from 2016-2018 under BPCA were reviewed using Clinicaltrials.gov to access the legislation's impact. CTs were categorized according to eligibility...Each drug was searched in DailyMed.com for published pediatric indications." The study tracked whether BPCA incentives resulted in both increased pediatric trial participation and pediatric drug label information, finding that while labeling improved, actual child recruitment in trials remained inadequate in many cases.
Study is observational and does not assess causality between BPCA participation and drug labeling outcomes. Limited to 2016-2018 period and US context. Does not compare clinical outcomes or safety between trials with high versus low pediatric participation.
Across countries and designs
1 study · 1 country
