A Tufts Center for the Study of Drug Development analysis found sponsors and CROs identify clinical trial risks but struggle to implement coordinated corrective action, highlighting an “execution translation gap.” The study reported that protocol deviations rose 56% over five years, with mean deviations increasing from 189 in 2020 to 296 in 2024. It also found that half of Phase III trial sites fail to enroll patients or miss targets, and that this enrollment problem has remained largely unchanged for two decades. The authors argued that the gap reflects organizational capability failures rather than a lack of knowledge, and they pointed to risk-management frameworks such as ICH E6 and ICH E8 as potential tools for improving corrective action. For biotech leaders, the report underscores how operational execution—site selection, mobilization, and cross-functional alignment—can determine whether well-designed protocols succeed in practice.