February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Phases of Clinical Trials: 6
Phase III Clinical Trials: Settings
Phase III: Common scenarios
Establish efficacy of new treatment
·superiority over no intervention
·superiority over existing treatment
Establish equivalence with current treatment
·Two-sided equivalence: bioequivalence
·One-sided equivalence: noninferiority
-perhaps superior on secondary endpoint
Establish harm of existing treatment