February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Session 1- Fixed Sample Design: 103
Case Study: Statistical Design Issues
Refining the primary endpoint (cont.)
Mortality rate at fixed point in time (binary data)
·
·Allows choice of scientifically relevant time frame
-single administration; short half life
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·Allows choice of clinically relevant time frame
-avoid sensitivity to improvements lasting only short periods of time