February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Session 1- Fixed Sample Design: 34
Defining the comparison groups
One arm trial: Historical or matched controls
·comparison to absolute reference
Two arm trial: Placebo or Active controls
·comparison between arms
Multiple arm trial: Several treatments or doses
·global tests vs pairwise comparisons
Regression trial: Continuous dose response
·test slope parameters
·
Also need to consider randomization ratio across treatment arms (or distribution of dose levels)
Number of Arms