Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • McDonnell, A; Rex, JH; Goossens, H; Bonten, M; Fowler, VG; Dane, A

Published Date

  • August 15, 2016

Published In

Volume / Issue

  • 63 Suppl 2 /

Start / End Page

  • S57 - S59

PubMed ID

  • 27481955

Pubmed Central ID

  • PMC4967592

Electronic International Standard Serial Number (EISSN)

  • 1537-6591

Digital Object Identifier (DOI)

  • 10.1093/cid/ciw244


  • eng

Conference Location

  • United States