Evidence map›Paper›PMID 29020279›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018

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

Stella Stergiopoulos, Sara B Calvert, Carrie A Brown, Josephine Awatin, Pamela Tenaerts, Thomas L Holland, Joseph A DiMasi, Kenneth A Getz

Abstract readClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. A Systematic Review of Health-Related Quality-of-Life Measurement in Patients With Hospital-Acquired/Ventilator-Associated Bacterial Pneumonia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Stella StergiopoulosTufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.
Sara B CalvertClinical Trials Transformation Initiative, Durham, North Carolina.
Carrie A BrownTufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.
Josephine AwatinTufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.
Pamela TenaertsClinical Trials Transformation Initiative, Durham, North Carolina.
Thomas L HollandDuke Clinical Research Institute, Durham, North Carolina.
Joseph A DiMasiTufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.
Kenneth A GetzTufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.

Funding

Increasing the Quality and Efficiency of Clinical Trials (R18)R18FD005292 · FDA · DUKE UNIVERSITY · PI LI, JENNIFER S · 2014 to 2019
$26.8M
FDA HHS R18 FD005292
6 · The paper itself

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.

Indexed as

Clinical Trials, Phase III as TopicCosts and Cost AnalysisHealthcare-Associated PneumoniaHospitalsHumansPneumonia, BacterialPneumonia, Ventilator-Associatedclinical trial costhabp vabphospital-acquired bacterial pneumoniaphase 3 clinical trialsventilator-associated bacterial pneumonia

Identifiers

PMID29020279
PMCPMC5848330

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.