Clinical trials


Ontology type: npg:Subject  | skos:Concept     


Concept Info

NAME

Clinical trials

DESCRIPTION

A clinical trial involves the study of the safety, efficacy and/or dosage regimen of a therapeutic intervention (such as a drug) in humans selected according to predetermined criteria of eligibility (such as a defined severity of a specific disease), who are observed for predefined evidence of favourable and unfavourable effects.

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97 skos:Concept
98 rdfs:label Phase II trials
99 skos:broader sg:ontologies/subjects/clinical-trials
100 skos:definition Phase II trials are conducted to provide evidence of the effectiveness of a therapeutic intervention in patients and to determine the optimal treatment regimen (for example, dosing schedule) for investigation in Phase III trials, and also provide further information on safety. They typically involve 100-300 patients with the disease intended to be treated by the intervention.
101 skos:inScheme sg:ontologies/subjects/
102 skos:prefLabel Phase II trials
103 sg:ontologies/subjects/phase-iii-trials sgo:sdDataset onto_subjects
104 rdf:type npg:Subject
105 skos:Concept
106 rdfs:label Phase III trials
107 skos:broader sg:ontologies/subjects/clinical-trials
108 skos:definition Phase III trials are conducted to provide stronger evidence of the effectiveness and safety of a therapeutic intervention and typically form a key part of applications to regulatory authorities to grant market approval. They usually involve 500-3000 or more patients and compare the therapeutic intervention with the current standard of care for patients with the disease intended to be treated.
109 skos:inScheme sg:ontologies/subjects/
110 skos:prefLabel Phase III trials
111 sg:ontologies/subjects/phase-iv-trials sgo:sdDataset onto_subjects
112 rdf:type npg:Subject
113 skos:Concept
114 rdfs:label Phase IV trials
115 skos:broader sg:ontologies/subjects/clinical-trials
116 skos:definition Phase IV trials are studies of therapeutic interventions following their market approval and are typically conducted to obtain additional data about the safety and effectiveness of the intervention; for example in broader patient populations than were studied in the Phase III trials that provided the basis for regulatory approval.
117 skos:inScheme sg:ontologies/subjects/
118 skos:prefLabel Phase IV trials
119 sg:ontologies/subjects/study-design sgo:sdDataset onto_subjects
120 rdf:type npg:Subject
121 skos:Concept
122 rdfs:label Clinical trial design
123 skos:broader sg:ontologies/subjects/medical-research
124 skos:definition Clinical trial design is a key aspect of the successful conduct of clinical trials. It involves deciding parameters such as the number of patients, the length of the trial, the comparator arm (in the case of randomized controlled trials) using information on current treatments, the anticipated effect of the therapeutic intervention being studied and applying biostatistics methods.
125 skos:inScheme sg:ontologies/subjects/
126 skos:narrower sg:ontologies/subjects/clinical-trials
127 sg:ontologies/subjects/randomized-controlled-trials
128 skos:prefLabel Clinical trial design
129 skos:Concept sgo:sdDataset for_codes
130 rdf:type rdfs:Class
131 rdfs:Resource
132 rdfs:subClassOf rdfs:Resource
133 skos:Concept
 




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