"Most of the expedited approvals studied (90%) were based on surrogate endpoints, and none of these has (yet) been shown to reliably predict clinical outcomes"
90% of drug fast track approvals by EU regulator NOT based on clinical outcomes. "Most of the expedited approvals by EMA studied (46/51; 90%) were based on surrogate endpoints, and none of these has (yet) been shown to reliably predict clinical outcomes."
Most of EMA expedited approvals studied (46/51; 90%) were based on surrogate endpoints, none of these has (yet) been shown to reliably predict clinical outcomes. This means we don’t know whether they will provide the intended clinical benefit for patients