A Tufts Center for the Study of Drug Development analysis argues that sponsors and CROs can spot clinical trial risks but struggle to execute coordinated corrective action when problems emerge. The study highlights measurable trial performance impacts tied to an “execution translation gap,” where organizational capability fails to convert identified issues into timely operational fixes. The report cites a 56% rise in mean protocol deviations per trial from 189 in 2020 to 296 in 2024. It also notes enrollment issues—half of Phase III sites either fail to enroll or under-enroll relative to targets, a challenge it says has persisted for two decades. For clinical leaders, the work emphasizes risk management frameworks such as ICH E6 and E8 as potential anchors for closing the execution loop across cross-functional teams.