1. Pink Sheet

Pediatric Data Planning Should Start While Adult Drug Development Is In Its Infancy

 
• By Bridget Silverman

Innovative trial designs and biostatistics can make pediatric drug development more efficient, but strategies like extrapolating adult data using bridging biomarkers or Bayesian analyses have complex data requirements that demand coordination and forethought.

pediatric patient with doctor (Alamy)
• Source: Alamy

Pediatric indications for GlaxoSmithKline plc’s Benlysta and Novartis AG’s Entresto stand out as successful examples of “complex innovative trial design,” embodying the theme the seventh workshop on Advancing the Development of Pediatric Therapeutics (ADEPT) hosted earlier this year by the FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Among the complex innovative trials designs proposed to make pediatric drug development more efficient, the M-CERSI/FDA meeting highlighted the use of bridging biomarkers in pediatric extrapolation, illustrated by Entresto’s approval...

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