title: Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs: 2015 Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health.
abstract: One important component in determining the benefits and harms of medical interventions is the use of well-defined and reliable outcome assessments as endpoints in clinical trials. Improving endpoints can better define patient benefits, allowing more accurate assessment of drug efficacy and more informed benefit-vs-risk decisions; another potential plus is facilitating efficient trial design. Since our first report in 2012, 2 Foundation for the National Institutes of Health Biomarkers Consortium Project Teams have continued to develop outcome assessments for potential uses as endpoints in registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. In addition, the teams have initiated similar work in the indications of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. This report provides an update on progress to date in these 4 diseases.
authors.affiliation: Talbot Advisors LLC, Anna Maria, Florida.
authors.forename: George H
authors.initials: GH
authors.lastname: Talbot
authors.affiliation: George Washington University School of Medicine, Washington, District of Columbia University of Maryland School of Medicine, Baltimore.
authors.forename: John H
authors.initials: JH
authors.lastname: Powers
authors.affiliation: Biomarkers Consortium, Foundation for the National Institutes of Health, Bethesda, Maryland.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Hoffmann
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D015415:Biomarkers; D002986:Clinical Trials as Topic; D023381:Endpoint Determination; D006287:Health Planning Guidelines; D006801:Humans; D017063:Outcome Assessment, Health Care; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*
chemical_list: D000900:Anti-Bacterial Agents; D015415:Biomarkers
keywords: antibacterial drug development; early clinical response; noninferiority trial design; patient-reported outcome; PRO