Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.
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.
McDonnell, A; Rex, JH; Goossens, H; Bonten, M; Fowler, VG; Dane, A
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