Journal Article

Clinical Trial Design and Consequences for Drug Development for Community-Acquired Pneumonia: An Industry Perspective

Glenn S. Tillotson and Roger M. Echols

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 47, issue Supplement_3, pages S237-S240
Published in print December 2008 | ISSN: 1058-4838
Published online December 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/591408
Clinical Trial Design and Consequences for Drug Development for Community-Acquired Pneumonia: An Industry Perspective

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Antibiotic development has decreased significantly, in part because of recent changes in regulatory requirements in the United States. These changes both decrease the probability of technical and regulatory success for a new antibiotic for which marketing approval is sought and motivate the pharmaceutical industry to focus its research efforts on other therapeutic areas. There is a growing, unmet clinical need for new antibiotics, because of bacterial resistance to approved drugs; however, there are few candidates in development, especially new oral agents for treatment of community-acquired respiratory infections. The answers to important questions about the benefit of antibacterial treatment for community-acquired pneumonia and the publication of clear guidance for future clinical studies will support future investments. We discuss the underlying issues and offer some alternative strategies to enable improvements in clinical trial design for community-acquired pneumonia.

Journal Article.  2860 words.  Illustrated.

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

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