February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Clinical trials
Experimentation in
human volunteers
Investigation of a
new treatment or preventive agent
·Safety: Are
there adverse effects that clearly outweigh any potential
benefit?
·Efficacy:
Can the treatment alter the disease process in a beneficial
way?
·Effectiveness:
Would adoption of the treatment as a standard affect
morbidity / mortality in the population?