Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks | Zendy

Anthony McDonnell | Zendy; John Rex | Zendy; Herman Goossens | Zendy; Marc J. M. Bonten | Zendy; Vance G. Fowler | Zendy; Aaron Dane | Zendy

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Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks

Author(s) -

Anthony McDonnell,

John Rex,

Herman Goossens,

Marc J. M. Bonten,

Vance G. Fowler,

Aaron Dane

Publication year - 2016

Publication title -

clinical infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.44

H-Index - 336

eISSN - 1537-6591

pISSN - 1058-4838

DOI - 10.1093/cid/ciw244

Subject(s) - medicine , clinical trial , investigational drugs , public health , quality (philosophy) , antibiotics , product (mathematics) , intensive care medicine , risk analysis (engineering) , microbiology and biotechnology , nursing , philosophy , geometry , mathematics , epistemology , biology

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.

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