FDA grant awarded to advance real-world evidence generation in neonatology

The Critical Path Institute (C-Path; AZ, USA) has been awarded a grant by the US FDA for a neonatal pilot project, through its International Neonatal Consortium, that will include the establishment of a real-world data and analytics platform, to advance standards and methods for generating real-world evidence to help facilitate clinical trial design and conduct in this vulnerable population. The multi-year grant will help support the collection of data from neonatal intensive care units across the world; the data will be deposited into a real-world data and analytics platform. Co-Principal Investigator on the grant, Jonathan Davis (Tufts Children’s Hospital, MA,...