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

Publication ,  Journal Article
McDonnell, A; Rex, JH; Goossens, H; Bonten, M; Fowler, VG; Dane, A
Published in: Clin Infect Dis
August 15, 2016

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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Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

August 15, 2016

Volume

63 Suppl 2

Issue

Suppl 2

Start / End Page

S57 / S59

Location

United States

Related Subject Headings

  • Practice Guidelines as Topic
  • Patient Outcome Assessment
  • Microbiology
  • Humans
  • Drug Discovery
  • Communicable Diseases
  • Clinical Trials as Topic
  • Anti-Bacterial Agents
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences
 

Citation

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McDonnell, A., Rex, J. H., Goossens, H., Bonten, M., Fowler, V. G., & Dane, A. (2016). Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks. Clin Infect Dis, 63 Suppl 2(Suppl 2), S57–S59. https://doi.org/10.1093/cid/ciw244
McDonnell, Anthony, John H. Rex, Herman Goossens, Marc Bonten, Vance G. Fowler, and Aaron Dane. “Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.Clin Infect Dis 63 Suppl 2, no. Suppl 2 (August 15, 2016): S57–59. https://doi.org/10.1093/cid/ciw244.
McDonnell A, Rex JH, Goossens H, Bonten M, Fowler VG, Dane A. Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks. Clin Infect Dis. 2016 Aug 15;63 Suppl 2(Suppl 2):S57–9.
McDonnell, Anthony, et al. “Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.Clin Infect Dis, vol. 63 Suppl 2, no. Suppl 2, Aug. 2016, pp. S57–59. Pubmed, doi:10.1093/cid/ciw244.
McDonnell A, Rex JH, Goossens H, Bonten M, Fowler VG, Dane A. Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks. Clin Infect Dis. 2016 Aug 15;63 Suppl 2(Suppl 2):S57–S59.
Journal cover image

Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

August 15, 2016

Volume

63 Suppl 2

Issue

Suppl 2

Start / End Page

S57 / S59

Location

United States

Related Subject Headings

  • Practice Guidelines as Topic
  • Patient Outcome Assessment
  • Microbiology
  • Humans
  • Drug Discovery
  • Communicable Diseases
  • Clinical Trials as Topic
  • Anti-Bacterial Agents
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences