-
Review
Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.
- Anthony McDonnell, John H Rex, Herman Goossens, Marc Bonten, Vance G Fowler, and Aaron Dane.
- UK Review on Antimicrobial Resistance, London.
- Clin. Infect. Dis. 2016 Aug 15; 63 Suppl 2: S57-9.
AbstractThe 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. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.
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