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Clinical Trial
. 2018 Jan 6;66(1):72-80.
doi: 10.1093/cid/cix726.

Cost Drivers of a Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Phase 3 Clinical Trial

Stella Stergiopoulos  1 , Sara B Calvert  2 , Carrie A Brown  1 , Josephine Awatin  1 , Pamela Tenaerts  2 , Thomas L Holland  3   4 , Joseph A DiMasi  1 , Kenneth A Getz  1
Affiliations
Clinical Trial

Cost Drivers of a Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Phase 3 Clinical Trial

Stella Stergiopoulos et al. Clin Infect Dis. .

Abstract

Background: Studies indicate that the prevalence of multidrug-resistant infections, including hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), has been rising. There are many challenges associated with these disease conditions and the ability to develop new treatments. Additionally, HABP/VABP clinical trials are very costly to conduct given their complex protocol designs and the difficulty in recruiting and retaining patients.

Methods: With input from clinicians, representatives from industry, and the US Food and Drug Administration, we conducted a study to (1) evaluate the drivers of HABP/VABP phase 3 direct and indirect clinical trial costs; (2) to identify opportunities to lower these costs; and (3) to compare (1) and (2) to endocrine and oncology clinical trials. Benchmark data were gathered from proprietary and commercial databases and used to create a model that calculates the fully loaded (direct and indirect) cost of typical phase 3 HABP/VABP endocrine and oncology clinical trials.

Results: Results indicate that the cost per patient for a 200-site, 1000-patient phase 3 HABP/VABP study is $89600 per patient. The cost of screen failures and screen failure rates are the main cost drivers.

Conclusions: Results indicate that biopharmaceutical companies and regulatory agencies should consider strategies to improve screening and recruitment to decrease HABP/VABP clinical trial costs.

Keywords: clinical trial cost; habp vabp; hospital-acquired bacterial pneumonia; phase 3 clinical trials; ventilator-associated bacterial pneumonia.

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Figures

Figure 1.
Figure 1.
Global region and site distribution assumptions in the phase 3 clinical trial costing model for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, oncology, and endocrine.
Figure 2.
Figure 2.
Cost impact of changing a single model assumption in a typical phase 3 hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia trial.
Figure 3.
Figure 3.
Cost impact of changing 2 model assumptions in a typical phase 3 hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia trial.
See this image and copyright information in PMC

References

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