In this issue of The Lancet Oncology, Joseph C Del Paggio and Ian F Tannock report findings from an analysis of the fragility index in phase 3 randomised controlled trials (RCTs) used to support US FDA approvals of cancer drugs between 2014 and 2018. Nine of 17 trials assessed had a fragility index of 2 or less; if two patients or fewer in the experimental group had had a progression or overall survival event instead of no event, the results would not have been significant. Of the 17 approved drugs, only one had more than one phase 3 trial as supportive evidence.
[Editorial] Are results from clinical trials reliable?
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