February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
“O’Brien-Fleming” stopping rule
At each interim analysis, stop early if sample mean is
indicated range
At the final analysis, the stopping must occur
N Harm Equiv
Efficacy
25 < -4.09 ---- > 4.09
50 < -2.05
(-0.006,0.006) > 2.05
75 < -1.36
(-0.684,0.684) > 1.36
100
< -1.023 (-1.023,1.023) > 1.023