Journal Article

Forum Report: Issues in the Design of Trials of Drugs for the Treatment of Invasive Aspergillosis

John E. Bennett, John Powers, Ben de Pauw, William Dismukes, John Galgiani, Michel Glauser, Raoul Herbrecht, Carol Kauffman, Jeannette Lee, Peter Pappas, John Rex, Paul Verweij, Claudio Viscoli and Thomas Walsh

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 36, issue Supplement_3, pages S113-S116
Published in print April 2003 | ISSN: 1058-4838
Published online April 2003 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/367838
Forum Report: Issues in the Design of Trials of Drugs for the Treatment of Invasive Aspergillosis

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A recent trial of drugs for invasive aspergillosis was used as a background for discussing critical features in the design of antifungal trials. The study under discussion allowed stopping either drug without classifying the patient as having treatment failure, so the trial should be understood as a comparison of 2 treatment strategies, not just 2 drugs. Although the study was a noninferiority trial, the outcome permitted a claim of superiority. Use of the category of “probable” in addition to “proven” aspergillosis permitted inclusion of patients for whom the diagnosis was less certain but who were still early enough in the disease progression to respond to therapy. Different opinions still exist about some of the criteria for the diagnosis of “probable” aspergillosis. A blinded data review committee was helpful in evaluating efficacy in this unblinded trial but had limited value in assessing toxicity. An understanding of these features of design of antifungal drug trials is important in applying the results to clinical practice.

Journal Article.  2498 words. 

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

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