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On 6/29/17, David Loose asked for this list to be aligned with https://prsinfo.clinicaltrials.gov/definitions.html. |
- Early Phase I - Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, micro dose microdose studies). See FDA guidance on exploratory IND studies for more information.
- I - Includes initial studies to determine the metabolism and pharmacologic actions of a medical approach drugs in humans, the side effects associated with increasing doses or exposure, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
- I/II - Includes trials Trials that are a combination of phases I 1 and II2.
- II - Includes controlled clinical studies conducted to evaluate the effectiveness of the medical approach drug for a particular indication or indications in patients participants with the disease or condition under study and to determine the common short-term side effects and risks.
- II/III - Trials that are a combination of phases II 2 and III3.
- III - Includes expanded controlled and uncontrolled trials conducted after preliminary evidence suggesting effectiveness of the medical approach drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling.
- IV - Studies of FDA-approved drugs , interventions, tests or diagnostic procedures to delineate additional information including the medical approach drug's risks, benefits, and optimal use.
- NA (Not applicable) - Trials without phases (for example, studies of devices or behavioral interventions).
