Journal Article

Challenges in the Design and Conduct of Clinical Trials for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia: An Industry Perspective

Steven L. Barriere

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 51, issue Supplement_1, pages S4-S9
Published in print August 2010 | ISSN: 1058-4838
Published online August 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/653033
Challenges in the Design and Conduct of Clinical Trials for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia: An Industry Perspective

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Hospital-acquired pneumonia and ventilator-associated pneumonia are associated with high rates of morbidity and mortality and are often caused by drug-resistant pathogens. Trials of potential new agents to treat these serious infections are complicated by various factors associated with their design and conduct and the complex underlying conditions of the patients that can potentially obscure determination of treatment benefits. Balancing scientific rigor and optimal patient management while maintaining logistical and financial feasibility is a challenge in the conduct of these studies. Regulatory guidance could help to standardize the design and conduct of trials evaluating potentially efficacious agents. In this article, some of the important challenges that were faced in conducting trials of agents to treat hospital-acquired pneumonia and ventilator-associated pneumonia are described, and areas for which regulatory guidance would be most useful are discussed.

Journal Article.  4014 words.  Illustrated.

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

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