February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Session 1- Fixed Sample Design: 5
Scientific Hypotheses: Treatment
Defining the treatment(s)
The “treatment” that we test in a clinical trial must be completely defined at the time of randomization
·dose(s)
·administration(s)
·frequency and duration of treatment
·ancillary treatments and treatment reduction
·
Relevance to “intent-to-treat” analyses