Journal Article

Increasing the Efficiency of Clinical Trials of Antimicrobials: The Scientific Basis of Substantial Evidence of Effectiveness of Drugs

John H. Powers

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 45, issue Supplement_2, pages S153-S162
Published in print September 2007 | ISSN: 1058-4838
Published online September 2007 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/519253
Increasing the Efficiency of Clinical Trials of Antimicrobials: The Scientific Basis of Substantial Evidence of Effectiveness of Drugs

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In the United States, drug sponsors must obtain approval from the US Food and Drug Administration before licensure and widespread clinical use of drugs. In this article, I discuss the definition and history of the regulatory requirement for “substantial evidence” of effectiveness from “adequate and well-controlled” clinical trials of drugs. These requirements apply to antimicrobials as they do to other therapeutic drug classes, and they may be even more important in their application to antimicrobials, given issues of antimicrobial resistance. I will discuss the evidence requirements, using examples from clinical trials in diseases such as acute otitis media, acute bacterial sinusitis, and acute exacerbations of chronic bronchitis. Examination of the principles of substantial evidence also points to opportunities to improve the efficiency of confirmatory clinical trials of antimicrobials to obtain more clinically relevant and useful information without increasing the uncertainty regarding the safety and efficacy of these drugs.

Journal Article.  8436 words. 

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

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