EBRO 2017

The problems with phase III

• Small effects mean (very …) large trials • many questions cannot be addressed • The results are disappointing • 510 phase III @ ASCO 1989-1998 • 223 (44%) with p ≤ 0.05 • 183 (36%) superiority of experimental arm • The results come too late

• not relevant for routine patients • obtained with obsolete modalities

Krzyzanowska JAMA 2003