A Tufts Center for the Study of Drug Development analysis warns that sponsors and CROs are identifying clinical trial risks but failing to execute coordinated corrective action—an issue the authors call the “execution translation gap.” The study links organizational execution weaknesses to measurable trial underperformance. The report cites a 56% rise in mean protocol deviations from 2020 to 2024 and notes that half of global Phase III sites either fail to enroll patients or miss enrollment targets, with the problem persisting for two decades. Authors Kenneth Getz and Kenneth Kaitin argue root causes are not being addressed systemically, with corrective steps remaining localized and transient. The analysis points to risk-management guidance such as ICH E6 and ICH E8 as potential tools to close the gap through better operational implementation of identified risks.