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

Autor: Thomas L. Holland, Josephine Awatin, Stella Stergiopoulos, Joseph A. DiMasi, Carrie A. Brown, Kenneth A. Getz, Sara B. Calvert, Pamela Tenaerts
Rok vydání: 2017
Předmět:
0301 basic medicine
Microbiology (medical)
medicine.medical_specialty
030106 microbiology
habp vabp
Phases of clinical research
ventilator-associated bacterial pneumonia
Disease
Pneumonia ventilator associated
03 medical and health sciences
0302 clinical medicine
Pneumonia
Bacterial
medicine
Humans
030212 general & internal medicine
Intensive care medicine
Articles and Commentaries
health care economics and organizations
Protocol (science)
phase 3 clinical trials
business.industry
Healthcare-Associated Pneumonia
hospital-acquired bacterial pneumonia
Bacterial pneumonia
Pneumonia
Ventilator-Associated
medicine.disease
Hospitals
3. Good health
Clinical trial
Infectious Diseases
Biopharmaceutical
Clinical Trials
Phase III as Topic
clinical trial cost
Cost driver
Costs and Cost Analysis
business
Zdroj: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
ISSN: 1537-6591
1058-4838
DOI: 10.1093/cid/cix726
Popis: A hospital-acquired and ventilator-associated bacterial pneumonia phase 3 clinical trial cost model estimates costs at $89600 per patient. The biggest cost driver is screen failure rates. Strategies to decrease screen failures are needed to improve the return on investment of these critically important studies.
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.
Databáze: OpenAIRE
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