|Biomedical Research and Regulation Work Group||Maturity Level : 1||Draft||Use Context : Any|
This is a code system defined by the FHIR project.
Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
|Committee:||Biomedical Research and Regulation Work Group|
|Source Resource||XML / JSON|
This Code system is used in the following value sets:
|n-a||N/A||Trials without phases (for example, studies of devices or behavioral interventions).|
|early-phase-1||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.|
See the full registry of code systems defined as part of FHIR.
Explanation of the columns that may appear on this page:
|Level||A few code lists that FHIR defines are hierarchical - each code is assigned a level. See Code System for further information.|
|Source||The source of the definition of the code (when the value set draws in codes defined elsewhere)|
|Code||The code (used as the code in the resource instance). If the code is in italics, this indicates that the code is not selectable ('Abstract')|
|Display||The display (used in the display element of a Coding ). If there is no display, implementers should not simply display the code, but map the concept into their application|
|Definition||An explanation of the meaning of the concept|
|Comments||Additional notes about how to use the code|