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Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology

AIM: The aim of the present study was to assess the estimated “per patient” total cost for a single Oncologic Italian Cancer Center participating in a multicenter clinical trial with new anticancer biological agents using the activity-based costing (ABC) methodology. METHODOLOGY: Nine randomized pha...

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Autores principales: Pascarella, Giacomo, Capasso, Arturo, Nardone, Antonio, Triassi, Maria, Pignata, Sandro, Arenare, Laura, Ascierto, Paolo, Curvietto, Marcello, Maiolino, Piera, D’Aniello, Roberta, Montanino, Agnese, Laudato, Francesca, De Feo, Gianfranco, Botti, Gerardo, Perrone, Francesco, Petrillo, Antonella, Cavalcanti, Ernesta, Lastoria, Secondo, Maurea, Nicola, Morabito, Alessandro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324822/
https://www.ncbi.nlm.nih.gov/pubmed/30620767
http://dx.doi.org/10.1371/journal.pone.0210330
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author Pascarella, Giacomo
Capasso, Arturo
Nardone, Antonio
Triassi, Maria
Pignata, Sandro
Arenare, Laura
Ascierto, Paolo
Curvietto, Marcello
Maiolino, Piera
D’Aniello, Roberta
Montanino, Agnese
Laudato, Francesca
De Feo, Gianfranco
Botti, Gerardo
Perrone, Francesco
Petrillo, Antonella
Cavalcanti, Ernesta
Lastoria, Secondo
Maurea, Nicola
Morabito, Alessandro
author_facet Pascarella, Giacomo
Capasso, Arturo
Nardone, Antonio
Triassi, Maria
Pignata, Sandro
Arenare, Laura
Ascierto, Paolo
Curvietto, Marcello
Maiolino, Piera
D’Aniello, Roberta
Montanino, Agnese
Laudato, Francesca
De Feo, Gianfranco
Botti, Gerardo
Perrone, Francesco
Petrillo, Antonella
Cavalcanti, Ernesta
Lastoria, Secondo
Maurea, Nicola
Morabito, Alessandro
author_sort Pascarella, Giacomo
collection PubMed
description AIM: The aim of the present study was to assess the estimated “per patient” total cost for a single Oncologic Italian Cancer Center participating in a multicenter clinical trial with new anticancer biological agents using the activity-based costing (ABC) methodology. METHODOLOGY: Nine randomized phase 3 clinical trials employing biological agents at the National Cancer Institute of Napoli, Italy, were analyzed to indentify “per patient” costs of each trial, according to the ABC methodology. The average consumption of resources for a patient completing the entire planned treatment was estimated for each trial. Through interviews of the personnel (doctors, nurses and technicians) and by analyses of the clinical trials protocols, the main activities of the 9 clinical trials were identified and, for each trial, the complete health care pathway of the patients and the treatment programmes were minutely reconstructed. Drug costs were not included because provided by Sponsors. PRINCIPAL FINDINGS: The average costs of the pre-study, treatment, monitoring, follow-up, audit, and administrative activities accounted for 2.357, 4.783, 700, 372, 1.263, and 9 Euro, respectively. The average total cost estimated for all “per patient” activities, including overhead costs, was 11.379 Euro. Staff costs accounted for € 5.988, while costs of diagnostic test accounted for 3.494 Euro. Clinical trials with immunotherapeutic drugs accounted for higher costs (+601 Euro as oncological staff costs, +1.318 Euro as intermediate services cost and +384 Euro as overheads). CONCLUSIONS: The average total cost estimated for all “per patient” activities of a clinical trial with new anticancer biological agents was 11.379 Euro using the ABC methodology.
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spelling pubmed-63248222019-01-19 Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology Pascarella, Giacomo Capasso, Arturo Nardone, Antonio Triassi, Maria Pignata, Sandro Arenare, Laura Ascierto, Paolo Curvietto, Marcello Maiolino, Piera D’Aniello, Roberta Montanino, Agnese Laudato, Francesca De Feo, Gianfranco Botti, Gerardo Perrone, Francesco Petrillo, Antonella Cavalcanti, Ernesta Lastoria, Secondo Maurea, Nicola Morabito, Alessandro PLoS One Research Article AIM: The aim of the present study was to assess the estimated “per patient” total cost for a single Oncologic Italian Cancer Center participating in a multicenter clinical trial with new anticancer biological agents using the activity-based costing (ABC) methodology. METHODOLOGY: Nine randomized phase 3 clinical trials employing biological agents at the National Cancer Institute of Napoli, Italy, were analyzed to indentify “per patient” costs of each trial, according to the ABC methodology. The average consumption of resources for a patient completing the entire planned treatment was estimated for each trial. Through interviews of the personnel (doctors, nurses and technicians) and by analyses of the clinical trials protocols, the main activities of the 9 clinical trials were identified and, for each trial, the complete health care pathway of the patients and the treatment programmes were minutely reconstructed. Drug costs were not included because provided by Sponsors. PRINCIPAL FINDINGS: The average costs of the pre-study, treatment, monitoring, follow-up, audit, and administrative activities accounted for 2.357, 4.783, 700, 372, 1.263, and 9 Euro, respectively. The average total cost estimated for all “per patient” activities, including overhead costs, was 11.379 Euro. Staff costs accounted for € 5.988, while costs of diagnostic test accounted for 3.494 Euro. Clinical trials with immunotherapeutic drugs accounted for higher costs (+601 Euro as oncological staff costs, +1.318 Euro as intermediate services cost and +384 Euro as overheads). CONCLUSIONS: The average total cost estimated for all “per patient” activities of a clinical trial with new anticancer biological agents was 11.379 Euro using the ABC methodology. Public Library of Science 2019-01-08 /pmc/articles/PMC6324822/ /pubmed/30620767 http://dx.doi.org/10.1371/journal.pone.0210330 Text en © 2019 Pascarella et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Pascarella, Giacomo
Capasso, Arturo
Nardone, Antonio
Triassi, Maria
Pignata, Sandro
Arenare, Laura
Ascierto, Paolo
Curvietto, Marcello
Maiolino, Piera
D’Aniello, Roberta
Montanino, Agnese
Laudato, Francesca
De Feo, Gianfranco
Botti, Gerardo
Perrone, Francesco
Petrillo, Antonella
Cavalcanti, Ernesta
Lastoria, Secondo
Maurea, Nicola
Morabito, Alessandro
Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology
title Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology
title_full Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology
title_fullStr Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology
title_full_unstemmed Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology
title_short Costs of clinical trials with anticancer biological agents in an Oncologic Italian Cancer Center using the activity-based costing methodology
title_sort costs of clinical trials with anticancer biological agents in an oncologic italian cancer center using the activity-based costing methodology
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324822/
https://www.ncbi.nlm.nih.gov/pubmed/30620767
http://dx.doi.org/10.1371/journal.pone.0210330
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