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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, microdose studies). See FDA guidance on exploratory IND studies for more information. |
I |
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. |
I/II |
Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
II | 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. |
II/III |
Phase 2/Phase 3 |
Trials that are a combination of phases 2 and 3. | |
III | 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. |
IV |
Phase 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. |
NA |
N/A |
Trials without phases (for example, studies of devices or behavioral interventions). |