Journal Article

Drug–Device Trials for Infectious Diseases: CDRH Perspective

Kristen L. Meier and Steven Gitterman

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 52, issue suppl_4, pages S367-S372
Published in print May 2011 | ISSN: 1058-4838
Published online May 2011 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1093/cid/cir053
Drug–Device Trials for Infectious Diseases: CDRH Perspective

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  • Infectious Diseases
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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.

Journal Article.  4465 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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