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Efficacy
Whether the new treatment can influence an outcome of interest in the chosen population.
Phase 1
Humans are involved, makes sure drug is safe, establishes correct dosage, and no placebos
Phase 2
Lowest success rate, no placebo, small # of patients, and uncommon side effects.
Phase 3
Large # of patients, treatment and control groups are brought in, and if drug is successful, it can be submitted for FDA approval.
Phase IV
Safest phase, usually approved by FDA, subjects closely monitored by physicians, and lasts for years.