Researchers argue that Europe’s clinical development bottlenecks are not solved by faster regulatory approvals alone. In a study published in Clinical Microbiology and Infection, authors point to operational problems—particularly enrollment shortfalls—and to rigid protocols that contribute to premature trial termination. The paper estimates that up to one-third of clinical trials end early due to operational issues and calls for greater regulatory support for adaptive protocols that evolve during an ongoing study. The authors cite the CoVacc pediatric COVID-19 vaccine experience as an example of how traditional processes struggle when the clinical context changes quickly. The report frames adaptive design as an approach that could shift regulatory focus from an initial application to ongoing review of structured protocol changes during active trials.
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