February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Session 1- Fixed Sample Design: 6
Scientific Hypotheses: Patient Population
Defining the target patient population
Inclusion/exclusion criteria to identify a population for whom
·A new treatment is needed
·Experimental treatment is likely to work
-and to work equally well in all subgroups
·All patients likely to eventually use the new treatment are represented
-Safety issues
·Clinical experimentation with the new treatment is not unethical