A Tufts Center for the Study of Drug Development analysis finds sponsors and CROs are increasingly identifying clinical trial risks but struggling to implement effective corrective action. The study links the problem to a widening “execution translation gap,” where issues aren’t converted into coordinated, timely operational changes. According to the report, protocol deviations rose 56% over five years, from an average of 189 per trial in 2020 to 296 in 2024. It also reports that about half of Phase III trial sites either fail to enroll or miss enrollment targets, a pattern that has persisted for two decades. The authors argue that regulatory frameworks such as ICH E6 and ICH E8 can support better risk management and reduce the operational drag on clinical development programs.