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FA 19 256
Does the drug SWIM? Phase 1 - small number of volunteers assess for Safety Phase 2 - moderate number of patients, does it Work Phase 3 - large number random assignment, with placebo, any Improvement? Phase 4 - hit the market, any unexpected side effects, can be withdrawn from Market
Phase I Small number of either healthy volunteers or patients with disease of interest. “Is it Safe?” Assesses safety, toxicity, pharmacokinetics, and pharmacodynamics.
Phase II Moderate number of patients with disease of interest. “Does it Work?” Assesses treatment efficacy, optimal dosing, and adverse effects.
Phase III Large number of patients randomly assigned either to the treatment under investigation or to the standard of care (or placebo). “Is it as good or better?” Compares the new treatment to the current standard of care (any Improvement?).
Phase IV Postmarketing surveillance of patients after treatment is approved. “Can it stay?” Detects rare or long-term adverse effects (eg, black box warnings). Can result in treatment being withdrawn from Market.