A Tufts Center for the Study of Drug Development analysis found sponsors and CROs struggle with an “execution translation gap,” where risks are identified but not effectively acted on during clinical trials. The study links the gap to measurable trial outcomes, including a 56% rise in protocol deviations per trial from 2020 to 2024 and a persistent enrollment problem where half of Phase III sites fail to enroll or miss targets. The report says the issue isn’t knowledge of regulatory guidance like ICH E6/E8 but organizational capability to mobilize cross-functional teams, align incentives, and implement systemic corrective actions. It argues localized fixes don’t create durable learning across trials. For biotech developers, the finding increases urgency to strengthen operational governance, risk-to-action playbooks, and site strategy implementation before trials move into late-stage enrollment.