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Description
This edge tracks the regulatory and clinical journey of a pharmacological agent as it is tested for efficacy and safety against a specific disease.
Properties
phase - The current or highest clinical trial phase reached.
No Phase (0)
Early Phase 1 (0.5): Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). See FDA guidance on exploratory IND studies for more information.
Phase 1: Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase 1/Phase 2 (1.5): Trials that are a combination of phases 1 and 2.
Phase 2: Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
Phase 2/Phase 3 (2.5): Trials that are a combination of phases 2 and 3.
Phase 3: Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
Phase 4: Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.
purpose - basic_science, diagnostic, prevention, screening, and treatment
sources - ClinicalTrials.gov via CTKP