C-Path Forms Consortium to Speed Development of Pediatric Drugs

The Critical Path Institute has formed the Global Pediatric Clinical Trials Network Pre-Launch Consortium to facilitate treatments for infants, children and adolescents — a top FDA priority.

Supported by an unrestricted grant from PhRMA, the aim is to provide the global infrastructure needed to plan, initiate, conduct and close out pediatric studies, C-Path says. Expected benefits include reduced time in planning and completing clinical trials, lower administrative costs and faster access to innovative medicines.

The effort will span all study types, trial phases, subspecialties and sponsors, from biopharma companies to government and nonprofits. The consortium’s role will be to set up the trials network, develop operational and organizational frameworks and name a leadership team.

In November, the FDA established an incentive program giving companies that win approval of a drug for a rare pediatric disease a voucher they can use to expedite review of another drug. — Kellen Owings