Code
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Display
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Definition
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n-a
|
N/A |
Trials without phases (for example, studies of devices or behavioral interventions). |
early-phase-1
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Early Phase 1 |
Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0. |
phase-1
|
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
|
Phase 1/Phase 2 |
Trials that are a combination of phases 1 and 2. |
phase-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
|
Phase 2/Phase 3 |
Trials that are a combination of phases 2 and 3. |
phase-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
|
Phase 4 |
Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. |