65 / 1983
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