February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Classification of
stages of investigation
Gradual accumulation
of experience in humans
·Phase I:
Initial safety / dose finding
·Phase II:
Preliminary efficacy / further safety
·Phase III:
Establishment of efficacy
·Phase
IV:
-Therapeutics: Post-marketing surveillance
-Prevention:
Effectiveness
Differing
focus across phases leads to different choices for design of studies