title: Recommendations for improving the design, conduct, and analysis of clinical trials in hospital-acquired pneumonia and ventilator-associated pneumonia.
abstract: Overall decisions on the clinical use of new antimicrobials depend on the validity and reliability of the evidence from appropriately designed, conducted, and analyzed clinical trials. Because pneumonia is the sixth leading cause of death in the United States and the leading cause of infectious disease-related death, appropriate design of trials in hospital-acquired pneumonia and ventilator-associated pneumonia are an important public health issue. Several issues with the current design of trials in hospital-acquired pneumonia and/or ventilator-associated pneumonia potentially bias their results and raise questions about their validity. These issues are magnified in the context of noninferiority trials, in which bias can make interventions appear more similar, giving false-positive results of safety and effectiveness. The goal of this article is to provide a scientific basis for improving the validity, reliability, and efficiency of clinical trials in hospital-acquired pneumonia and/or ventilator-associated pneumonia to provide better information for decision making for patients, clinicians, regulators, and other stakeholders.
authors.affiliation: Scientific Applications International Corporation, Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, George Washington University School of Medicine; and University of Maryland School of Medicine, Bethesda, Maryland, USA. powersjohn@mail.nih.gov
authors.forename: John H
authors.initials: JH
authors.lastname: Powers
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003428:Cross Infection / Q000188:drug therapy* / Q000382:microbiology; D006761:Hospitals; D006801:Humans; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D053717:Pneumonia, Ventilator-Associated / Q000188:drug therapy* / Q000382:microbiology; D012107:Research Design; D016896:Treatment Outcome; D014481:United States
chemical_list: D000900:Anti-Bacterial Agents