February, 2003
© 2000 Scott S. Emerson, M.D., Ph.D.
Session 4: 60
Case Study 1: Idarubicin in AML
FDA Questions
Was the O’Brien-Fleming design truly the one used?
·Number and timing of analyses
·Level of test
·Boundary shape function
(Can we trust retrospective imposition of the stopping rule?) (Case Study 2)
(Interpretation of secondary endpoint of survival?)