February, 2003
© 2000, 2001 Scott S. Emerson, M.D., Ph.D.
Selection
of stopping rules for use with safety endpoints
Need to consider
whether harm should be proven
·existing
treatments
·
I think
that the general philosophy of clinical testing dictates that such a
stopping rule should not be as conservative as those typically
used for efficacy endpoints
·An
O’Brien-Fleming guideline is probably too conservative for safety