February, 2003
© 2000, 2001 Scott S. Emerson, M.D., Ph.D.
Statistical
issues when using aggregate statistics to examine the safety profile
(cont.)
Group
sequential methods for monitoring safety profiles
·Bayesian
approaches
-But how do
you ever detect unexpected toxicities-- where is the burden of
proof?
·Frequentist
approaches
-Using group
sequential stopping rules to compute
-Repeated
confidence intervals
-Ersatz P
values