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Descriptor English: Clinical Trial, Phase III
Descriptor Spanish: Ensayo Clínico Fase III
Descriptor ensayo clínico fase III
Scope note: Trabajo que es el informe de un estudio clínico prepalnificado, por lo general controlado, sobre la seguridad y eficacia de medios diagnósticos o medicamentos terapéuticos o profilácticos, dispositivos o técnicas después de los estudios en fase II. Se estudia un grupo de pacientes con un tamaño suficientemente grande y se monitoriza estrechamente por médicos en busca de una respuesta desfavorable a la exposición a largo plazo, durante un período de aproximadamente tres años ya en los Estados Unidos o en un país extranjero.
Descriptor Portuguese: Ensaio Clínico Fase III
Descriptor French: Essai clinique de phase III
Entry term(s): Clinical Trial, Phase 3
Tree number(s): V03.175.250.300
RDF Unique Identifier: https://id.nlm.nih.gov/mesh/D017428
Scope note: Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques after phase II trials. A large enough group of patients is studied and closely monitored by physicians for adverse response to long-term exposure, over a period of about three years in either the United States or a foreign country.
Annotation: this heading is used as a Publication Type; for original report of the conduct or results of a specific phase III clinical trial; a different heading CLINICAL TRIALS, PHASE III AS TOPIC is used for general design, methodology, economics, etc. of Phase III clinical trials.
Allowable Qualifiers: No qualifiers
History Note: 2008(1993)
DeCS ID: 30964
Unique ID: D017428
Documents indexed in the Virtual Health Library (VHL): Click here to access the VHL documents
Date Established: 1996/01/01
Date of Entry: 1995/06/23
Revision Date: 2015/04/15
Clinical Trial, Phase III - Preferred
Concept UI M0026442
Scope note Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques after phase II trials. A large enough group of patients is studied and closely monitored by physicians for adverse response to long-term exposure, over a period of about three years in either the United States or a foreign country.
Preferred term Clinical Trial, Phase III
Entry term(s) Clinical Trial, Phase 3



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