8 July 2019 - The fragility index of trial results—ie, the minimum number of changes from non-events to events resulting in loss of statistical significance—can provide a measure of confidence that a positive effect reported in a randomised controlled trial is real.
Del Paggio & Tannock aimed to calculate the fragility index of randomised controlled trials supporting US FDA approved anti-cancer drugs.
This is a retrospective analysis of phase 3, randomised, controlled trials supporting anti-cancer drugs that were approved by the FDA between 1 January 2014 and 31 December 2018.