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Eagle-I Research Resource Ontology
| Preferred Name | Phase | |
| Synonyms |
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| Definitions |
Phase describes the level of a trial required of drugs before (and after) they are routinely used in clinical practice: - Phase I trials assess toxic effects on humans (not many people participate in them, and usually without controls); - Phase ll trials assess therapeutic benefit (usually involving a few hundred people, usually with controls, but not always); - Phase III trials compare the new treatment against standard (or placebo) treatment (usually a full randomised controlled trial). At this point, a drug can be approved for community use. - Phase IV monitors a new treatment in the community, often to evaluate longterm safety and effectiveness. [Glossary of Terms in The Cochrane Collaboration] A trial can be of a combination phase (e.g., I/II). The concept of phase is not applicable to trials studying certain interventions (e.g., device, procedure, behavioral) |
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| ID |
http://purl.org/net/OCRe/study_design.owl#OCRE100038 |
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| definition |
Phase describes the level of a trial required of drugs before (and after) they are routinely used in clinical practice:
- Phase I trials assess toxic effects on humans (not many people participate in them, and usually without controls);
- Phase ll trials assess therapeutic benefit (usually involving a few hundred people, usually with controls, but not always);
- Phase III trials compare the new treatment against standard (or placebo) treatment (usually a full randomised controlled trial). At this point, a drug can be approved for community use.
- Phase IV monitors a new treatment in the community, often to evaluate longterm safety and effectiveness. [Glossary of Terms in The Cochrane Collaboration]
A trial can be of a combination phase (e.g., I/II).
The concept of phase is not applicable to trials studying certain interventions (e.g., device, procedure, behavioral)
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| label |
Phase
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| prefLabel |
Phase
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| term editor |
Simona
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