Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.
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2016-08-15
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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.
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McDonnell, Anthony, John H Rex, Herman Goossens, Marc Bonten, Vance G Fowler and Aaron Dane (2016). Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks. Clin Infect Dis, 63 Suppl 2. pp. S57–S59. 10.1093/cid/ciw244 Retrieved from https://hdl.handle.net/10161/13300.
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Scholars@Duke
Vance Garrison Fowler
Determinants of Outcome in Patients with Staphylococcus aureus Bacteremia
Antibacterial Resistance
Pathogenesis of Bacterial Infections
Tropical medicine/International Health
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