Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.
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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.
Published Version (Please cite this version)10.1093/cid/ciw244
Publication InfoBonten, M; Dane, A; Fowler, Vance Garrison Jr; Goossens, H; McDonnell, A; & Rex, JH (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 http://hdl.handle.net/10161/13300.
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Professor of Medicine
Determinants of Outcome in Patients with Staphylococcus aureus Bacteremia Pathogenesis of Bacterial Infections Infections due to Resistant Gram Positive Organisms Tropical medicine/International Health