A Tufts Center for the Study of Drug Development analysis warned of a widening “execution translation gap” between identifying clinical trial risks and implementing corrective action. The study reported rising protocol deviations and persistent enrollment problems across Phase III trials, suggesting systemic breakdowns in how sponsors mobilize cross-functional teams. The analysis cited a 56% increase in mean protocol deviations per trial from 2020 to 2024 (189 to 296) and said half of Phase III sites either fail to enroll or under-enroll relative to targets—an issue that has remained stable for decades. For biotech leaders, the takeaway is operational: improving risk detection is not enough without better governance, incentives, and risk-managed processes to convert signals into timely changes.
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