Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks

Clin Infect Dis. 2016 Aug 15;63 Suppl 2(Suppl 2):S57-9. doi: 10.1093/cid/ciw244.

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.

Keywords: antibiotic development; antimicrobial resistance; trial networks.

Publication types

  • Review

MeSH terms

  • Anti-Bacterial Agents / therapeutic use*
  • Clinical Trials as Topic*
  • Communicable Diseases / drug therapy*
  • Drug Discovery / methods*
  • Humans
  • Patient Outcome Assessment*
  • Practice Guidelines as Topic

Substances

  • Anti-Bacterial Agents