title: Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.
abstract: The economics of antibiotics can be improved by infectious diseases-specific clinical trial networks. While developers would still need to implement an independent phase 1 program as well as studies focused on highly resistant pathogens, standardized procedures in a network focused on usual drug resistance phenotype isolates would permit sharing of controls and would predictably generate high-quality pivotal data for product registration while creating cost and time savings in the range of 30%-40%. This would reduce economic barriers to antibiotic development and contribute to public health.
authors.affiliation: UK Review on Antimicrobial Resistance, London.
authors.forename: Anthony
authors.initials: A
authors.lastname: McDonnell
authors.affiliation: AstraZeneca Pharmaceuticals, Waltham, Massachusetts University of Texas Medical School-Houston.
authors.forename: John H
authors.initials: JH
authors.lastname: Rex
authors.affiliation: Laboratory of Medical Microbiology, VAXINFECTIO, University Hospital of Antwerp, Belgium.
authors.forename: Herman
authors.initials: H
authors.lastname: Goossens
authors.affiliation: Department of Medical Microbiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.
authors.forename: Marc
authors.initials: M
authors.lastname: Bonten
authors.affiliation: Division of Infectious Diseases and Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina;
authors.forename: Vance G
authors.initials: VG
authors.lastname: Fowler
authors.affiliation: AstraZeneca Pharmaceuticals, Alderley Park, United Kingdom.
authors.forename: Aaron
authors.initials: A
authors.lastname: Dane
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003141:Communicable Diseases / Q000188:drug therapy*; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D063868:Patient Outcome Assessment; D017410:Practice Guidelines as Topic
chemical_list: D000900:Anti-Bacterial Agents
keywords: antibiotic development; antimicrobial resistance; trial networks