Popping at the seams.

This viewpoint suggests the validity of “seamless” clinical trial designs can fall apart without any of the seams. These designs became popular a couple of years ago under FDA commissioner Gottlieb as an efficient means of expediting otherwise notoriously lengthy drug approval processes. They work by expanding promising cohorts in earlier phases and allowing them to seamlessly progress through later phases of trial comparisons. While great in theory, these authors point out that starting out so broadly—such as in tissue agnostic basket trials—pretty much cancels out the statistical significance of any signal of efficacy. In other words, seamless expansion trials are fishing expeditions designed to ensure they catch something eventually. TBL: Seamless adaptive clinical trials can quickly morph into something far outside the scope of a priori detailed statistical methods. | Huchinson, J Clin Oncol 2019


Popular Posts