The Shift Toward One: Why One Pivotal Study Demands One Essential TMF
Siegrid Delgadillo
In our recent blog examining the FDA’s move toward a one pivotal trial approval pathway, we explored what this shift means for clinical strategy, regulatory engagement, and evidentiary rigor. As development programs concentrate approval decisions into a single adequate and well-controlled study, the implications extend well beyond protocol design and statistical planning. If one study carries the weight of approval, then... The post The Shift Toward One: Why One Pivotal Study Demands One Essent