Posted by Michael Wonder on 21 Aug 2018
FDA analysis shows similar success rates for paediatric trials using clinical and surrogate outcomes
21 August 2018 - An analysis by US FDA officials published earlier this month finds that there is a similar success rate for paediatric pivotal trials relying on surrogate endpoints compared to trials that use clinical endpoints.
While the authors find the use of surrogate outcomes in paediatric trials is effective, they argue that it is critical for endpoints that are unique to paediatric studies to be validated, as a higher proportion of paediatric studies that used a different endpoint than the corresponding adult trial failed.
Prior to efforts to incentivise paediatric drug development beginning with the Written Request program under the Food and Drug Administration Modernization Act in 1997, very few paediatric studies were conducted.
