Journal Article

Need for Alternative Trial Designs and Evaluation Strategies for Therapeutic Studies of Invasive Mycoses

John H. Rex, Thomas J. Walsh, Mary Nettleman, Elias J. Anaissie, John E. Bennett, Eric J. Bow, A. J. Carillo-Munoz, Pascal Chavanet, Gretchen A. Cloud, David W. Denning, Ben E. de Pauw, John E. Edwards, John W. Hiemenz, Carol A. Kauffman, Gabriel Lopez-Berestein, Pietro Martino, Jack D. Sobel, David A. Stevens, Richard Sylvester, Jan Tollemar, Claudio Viscoli, Maria A. Viviani and Teresa Wu

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 33, issue 1, pages 95-106
Published in print July 2001 | ISSN: 1058-4838
Published online July 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/320876
Need for Alternative Trial Designs and Evaluation Strategies for Therapeutic Studies of Invasive Mycoses

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Studies of invasive fungal infections have been and remain difficult to implement. Randomized clinical trials of fungal infections are especially slow and expensive to perform because it is difficult to identify eligible patients in a timely fashion, to prove the presence of the fungal infection in an unequivocal fashion, and to evaluate outcome in a convincing fashion. Because of these challenges, licensing decisions for antifungal agents have to date depended heavily on historical control comparisons and secondary advantages of the new agent. Although the availability of newer and potentially more effective agents makes these approaches less desirable, the fundamental difficulties of trials of invasive fungal infections have not changed. Therefore, there is a need for alternative trial designs and evaluation strategies for therapeutic studies of invasive mycoses, and this article summarizes the possible strategies in this area.

Journal Article.  8374 words.  Illustrated.

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

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