No renaissance for Genasense

While the pace of discussion about adaptive trial designs has been accelerating, drug developers may be looking for concrete motivations to actually take the risk of innovating in the clinic.

Although the topic did not come up at last week’s meeting of FDA’s Oncologic Drugs Advisory Committee, it is clear that adaptive trials, especially when benefits are restricted to a small subpopulation, might nudge cancer drug development away from the conflict over the value of modest response rates that has caused several late-stage failures. ...