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

Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks

Anthony McDonnell  1 , John H Rex  2 , Herman Goossens  3 , Marc Bonten  4 , Vance G Fowler Jr  5 , Aaron Dane  6
Affiliations
Review

Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks

Anthony McDonnell et al. Clin Infect Dis. .

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.

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Figures

Figure 1.
Figure 1.
Shown are 3 years in the life of a network. To start the network, a target infection is chosen (eg, complicated intra-abdominal infection), a standard protocol is prepared, and a widely registered excellent standard comparator (control A) is selected. After a brief run-in period, test drugs are flexibly added and removed from the network. A constant control arm (control A) is envisioned, but alternative controls can also be used as needed to address issues such as blinding (control B paired with test 2). Multiple agents can be in the network simultaneously. It is also assumed that data on control agents can be shared across drugs (see text).
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References

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