Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs

Introduction: From the perspective of healthcare organizations and public health care systems, the value of a clinical trial can be assessed from a clinical and economical perspective. However, to date, there is no standardized model for systematically capturing the economic value of clinical trials...

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Main Authors: Americo Cicchetti, Domenico Addesso, Filippo Elvino Leone, Antonino Amato, Luca Angerame, Angelo D'Aversa, Mario Fraticelli, Carlo Nicora, Eleonora Sfreddo, Mariangela Fumarola, Roberta Porcino, Gabriella Cocciolo, Simona Re, Sergio Scaccabarozzi
Format: Article
Language:English
Published: AboutScience Srl 2020-06-01
Series:Global & Regional Health Technology Assessment
Subjects:
Online Access:https://journals.aboutscience.eu/index.php/grhta/article/view/709
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author Americo Cicchetti
Domenico Addesso
Filippo Elvino Leone
Antonino Amato
Luca Angerame
Angelo D'Aversa
Mario Fraticelli
Carlo Nicora
Eleonora Sfreddo
Mariangela Fumarola
Roberta Porcino
Gabriella Cocciolo
Simona Re
Sergio Scaccabarozzi
author_facet Americo Cicchetti
Domenico Addesso
Filippo Elvino Leone
Antonino Amato
Luca Angerame
Angelo D'Aversa
Mario Fraticelli
Carlo Nicora
Eleonora Sfreddo
Mariangela Fumarola
Roberta Porcino
Gabriella Cocciolo
Simona Re
Sergio Scaccabarozzi
author_sort Americo Cicchetti
collection DOAJ
description Introduction: From the perspective of healthcare organizations and public health care systems, the value of a clinical trial can be assessed from a clinical and economical perspective. However, to date, there is no standardized model for systematically capturing the economic value of clinical trials at organizational and system levels. The aim of this study was to develop and test a methodology for estimating the avoided costs deriving from the management of patients as part of a clinical trial. Methods: Our methodology is based on the assumption that the economic value of a clinical trial derives from 1) the funding received by the experimental site from a trial’s sponsor, and from 2) the cost avoided by the experimental site with the treatment of patients within a study and not according to standard care by the experimental site.  Results: By applying the methodology to onco-hematological clinical trials conducted in two academic hospitals from 2011 to 2016, we demonstrate that savings between 2 million and 4 million euros were achieved over a five-year period. Thus, for every 1,000 euros invested by the pharmaceutical company into the clinical studies conducted at these hospitals, the hospitals saved on average 2,200 euros due to costs not incurred as a result of the trials. Conclusions: The study has proposed and tested a methodology for estimating the economic value of clinical trials by taking into account avoided costs deriving from the treatment of patients enrolled in sponsored trials. The study has proposed a management tool for healthcare institutions to govern clinical trials.
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spelling doaj.art-59018222c2794f4bb0680c14fc0af7a32022-12-22T03:06:50ZengAboutScience SrlGlobal & Regional Health Technology Assessment2284-24032283-57332020-06-017110.33393/grhta.2020.709Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costsAmerico Cicchetti0Domenico Addesso1Filippo Elvino Leone2Antonino Amato3Luca Angerame4Angelo D'Aversa5Mario Fraticelli6Carlo Nicora7Eleonora Sfreddo8Mariangela Fumarola9Roberta Porcino10Gabriella Cocciolo11Simona Re12Sergio Scaccabarozzi13Alta Scuola di Economia e Management dei Sistemi Sanitari, Università Cattolica del Sacro Cuore, Rome - ItalyAlta Scuola di Economia e Management dei Sistemi Sanitari, Università Cattolica del Sacro Cuore, Rome - ItalyAlta Scuola di Economia e Management dei Sistemi Sanitari, Università Cattolica del Sacro Cuore, Rome - ItalyAlta Scuola di Economia e Management dei Sistemi Sanitari, Università Cattolica del Sacro Cuore, Rome - ItalyAlta Scuola di Economia e Management dei Sistemi Sanitari, Università Cattolica del Sacro Cuore, Rome - ItalyFondazione Policlinico Universitario “A. Gemelli” IRCCS, Rome - ItalyAzienda Socio-Sanitaria Territoriale (ASST) Papa Giovanni XXIII di Bergamo, Bergamo - ItalyFondazione IRCCS Policlinico S. Matteo, Pavia - ItalyFondazione per la Ricerca, Ospedale di Bergamo, Bergamo - ItalyFondazione per la Ricerca, Ospedale di Bergamo, Bergamo - ItalyAzienda Socio-Sanitaria Territoriale (ASST) Papa Giovanni XXIII di Bergamo, Bergamo - ItalyRoche S.p.A., Monza (MB) - ItalyRoche S.p.A., Monza (MB) - ItalyRoche S.p.A., Monza (MB) - ItalyIntroduction: From the perspective of healthcare organizations and public health care systems, the value of a clinical trial can be assessed from a clinical and economical perspective. However, to date, there is no standardized model for systematically capturing the economic value of clinical trials at organizational and system levels. The aim of this study was to develop and test a methodology for estimating the avoided costs deriving from the management of patients as part of a clinical trial. Methods: Our methodology is based on the assumption that the economic value of a clinical trial derives from 1) the funding received by the experimental site from a trial’s sponsor, and from 2) the cost avoided by the experimental site with the treatment of patients within a study and not according to standard care by the experimental site.  Results: By applying the methodology to onco-hematological clinical trials conducted in two academic hospitals from 2011 to 2016, we demonstrate that savings between 2 million and 4 million euros were achieved over a five-year period. Thus, for every 1,000 euros invested by the pharmaceutical company into the clinical studies conducted at these hospitals, the hospitals saved on average 2,200 euros due to costs not incurred as a result of the trials. Conclusions: The study has proposed and tested a methodology for estimating the economic value of clinical trials by taking into account avoided costs deriving from the treatment of patients enrolled in sponsored trials. The study has proposed a management tool for healthcare institutions to govern clinical trials.https://journals.aboutscience.eu/index.php/grhta/article/view/709Avoided costsClinical trialsHealthcare management
spellingShingle Americo Cicchetti
Domenico Addesso
Filippo Elvino Leone
Antonino Amato
Luca Angerame
Angelo D'Aversa
Mario Fraticelli
Carlo Nicora
Eleonora Sfreddo
Mariangela Fumarola
Roberta Porcino
Gabriella Cocciolo
Simona Re
Sergio Scaccabarozzi
Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs
Global & Regional Health Technology Assessment
Avoided costs
Clinical trials
Healthcare management
title Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs
title_full Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs
title_fullStr Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs
title_full_unstemmed Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs
title_short Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs
title_sort valorization of clinical trials from the italian national health service perspective definition and first application of a model to estimate avoided costs
topic Avoided costs
Clinical trials
Healthcare management
url https://journals.aboutscience.eu/index.php/grhta/article/view/709
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