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- OCRE100038 IAO_0000115 "Phase describes the level of a trial required of drugs before (and after) they are routinely used in clinical practice: \n- Phase I trials assess toxic effects on humans (not many people participate in them, and usually without controls); \n- Phase ll trials assess therapeutic benefit (usually involving a few hundred people, usually with controls, but not always); \n- 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. \n- Phase IV monitors a new treatment in the community, often to evaluate longterm safety and effectiveness. [Glossary of Terms in The Cochrane Collaboration]\n\nA trial can be of a combination phase (e.g., I/II).\nThe concept of phase is not applicable to trials studying certain interventions (e.g., device, procedure, behavioral)".
- OCRE100038 IAO_0000117 "Simona".
- OCRE100038 type Class.
- OCRE100038 label "Phase".
- OCRE100038 subClassOf BFO_0000015.