February, 2003
© 2000, 2001 Scott S. Emerson, M.D., Ph.D.
Session 3: 51
Measuring Study Time
Example
A clinical trial of a binary endpoint is designed using a unified family design
·One-sided test for an increased event probability
·Designed with 5 analyses
·O’Brien-Fleming efficacy boundary
·Futility boundary intermediate to O’Brien-Fleming and Pocock