30
Clinical Trials
Experimentation in
human volunteers
–Efficacy: Can the
treatment alter the disease process in a beneficial way?
•Phase II
(preliminary); Phase III
–Safety: Are there
adverse effects that clearly outweigh any potential benefit?
•Phase I; Phase II
–Effectiveness: Would
adoption of the treatment as a standard affect morbidity / mortality
in the population?
•Phase III (therapy);
Phase IV (prevention)