[Correspondence] Go, no-go decision making for phase 3 clinical trials: ACT IV revisited – Authors' reply

We appreciate not only the interest of H Ian Robins and colleagues in the ACT IV trial,1 but also the thoughtful commentary by Elizbeth R Gerstner. From the perspective of several years' additional experience with clinical trial conduct in newly diagnosed glioblastoma relative to the time when ACT IV was designed, we feel that the failure to adequately estimate efficacy with a new treatment based on historical controls (even when matched for eligibility) provides a good lesson to be learned.

Source: The Lancet Oncology - November 30, 2017 Category: Cancer & Oncology Authors: Michael Weller, Nicholas Butowski, David D Tran, Lawrence D Recht, Michael Lim, Hal Hirte, Lynn Ashby, Laszlo Mechtler, Samuel A Goldlust, Fabio Iwamoto, Jan Drappatz, Donald M O'Rourke, Mark Wong, Mark G Hamilton, Gaetano Finocchiaro, James Perry, Wolfga Tags: Correspondence Source Type: research