Drug-device trials for infectious diseases: CDRH perspective.
Clin Infect Dis
; 52 Suppl 4: S367-72, 2011 May.
Article
em En
| MEDLINE
| ID: mdl-21460298
ABSTRACT
Assessing the performance of new diagnostic tests for infectious diseases has traditionally focused on comparing the new assay against a reference standard such as culture. In this paper, we suggest that clinical trial designs with both a diagnostic and therapeutic component may be necessary to evaluate the safety and effectiveness of nonmicrobiologically based assays, with a specific emphasis on the test/marker-stratified design. General design challenges for trials of infectious diseases that simultaneously study both diagnostic and therapeutic components (eg, both devices and drugs) are also discussed.
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MEDLINE
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Doenças Transmissíveis
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Ensaios Clínicos como Assunto
Limite:
Humans
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article