Conducting randomized controlled trials (RCTs) in children is exceptionally challenging because of low disease burden, ethical considerations, and limited funding. The number of RCTs in children are few, representing an urgent and unmet need. Coon et al describe an approach to RCTs in hospitalized children characterized by dispersed low-volume recruitment, incentives, pragmatic questions, streamlined regulatory process, and simultaneous conduct of multiple trials. They conclude that the High Efficiency RandOmIzed Controlled (HEROIC) approach will result in fast, agile, cost-effective, and generalizable RCTs.

The HEROIC approach is promising in several ways. Dispersed low-volume recruitment is successful in other networks including the Pediatric Trials Network (PTN). The PTN comprises >200 sites across North America and provides scientific, technical, and administrative infrastructure necessary to conduct safe, effective, and efficient trials in children. Over the last 12 years, the PTN has used a dispersed recruitment model to enroll >11 000 children across...

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