TABLE 1.

Potential solutions to improve drug safety and effectiveness evaluations in the pediatric population.

Proposed solutions	Details	Example
Active collection of postmarket adverse events	Active patient-reported safety events	V-safe after vaccination health checker
	Active pharmacovigilance using real-world data	FDA sentinel program
Operationalize and better leverage	Link electronic health records, registries, and claims	Tennessee Medicaid Mother-Child Linked Cohort
existing data	databases	Clinical Practice Research Link (UK) Pediatric Health Information System-The Cystic Fibrosis Foundation Patient Registry Linkage
	Develop national database and registries using universal data-sharing agreements	Korean National Health Insurance Service (KNIS) database
		Finnish, Swedish, and Danish National Registries
	Enhance public-private partnerships across	FDA Sentinel Initiative
	insurance and health systems	Israel-Pfizer Real-World Epidemiological Evidence Collaboration Agreement
	Promote common data models and interinstitutional partnerships	FDA Sentinel Initiative Common Data Model
		The Observational Health Data Science and Informatics (OHDSI) Program
Incorporate children into clinical trials using novel methods	Evaluation of pediatric medications in the	Pragmatic Clinical Trials
	real-world setting
	Leveraging heterogeneity of pediatric care	High-Efficiency RandOmIzed Controlled (HEROIC) trials
	Safety-centered outcome trials	AHRQ Trigger Tools