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On 6/29/17, David Loose asked for this list to be aligned with https://prsinfo.clinicaltrials.gov/definitions.html. |
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CTRP Phase Value | ClinicalTrials.gov Phase Value | Definition |
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Early Phase I | Early Phase 1 (Formerly listed as "Phase 0") |
Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, |
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microdose studies). See FDA guidance on exploratory IND studies for more information. |
I |
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Phase 1 | Includes initial studies to determine the metabolism and pharmacologic actions of |
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drugs in humans, the side effects associated with increasing doses |
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, and to gain early evidence of effectiveness; may include healthy participants and/or patients. |
I/II |
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Phase 1/Phase 2 | Trials that are a combination of phases |
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1 and |
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2. |
II |
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Phase 2 | Includes controlled clinical studies conducted to evaluate the effectiveness of the |
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drug for a particular indication or indications in |
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participants with the disease or condition under study and to determine the common short-term side effects and risks. |
II/III |
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Phase 2/Phase 3 | Trials that are a combination of phases |
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2 and |
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3. |
III |
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Phase 3 | Includes trials conducted after preliminary evidence suggesting effectiveness of the |
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drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug |
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IV |
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Phase 4 | Studies of FDA-approved drugs |
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to delineate additional information including the |
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drug's risks, benefits, and optimal use. |
NA |
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N/A | Trials without phases (for example, studies of devices or behavioral interventions). |