Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs
DOI:
https://doi.org/10.33393/grhta.2020.709Keywords:
Avoided costs, Clinical trials, Healthcare managementAbstract
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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References
Agenzia Italiana del Farmaco (2019). La Sperimentazione Clinica dei Medicinali in Italia. 18° Rapporto Nazionale, Roma.
Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ 2009;180(3):277–8.
Cicchetti A, Addesso D, Amato A et al. Valorizzazione delle sperimentazioni cliniche nella prospettiva del SSN: Definizione di un modello per una stima dei costi evitati. Milano: Edra, 2018.
Tang PA, Hay AE, O’Callaghan CJ et al. Estimation of drug cost avoidance and pathology cost avoidance through participation in NCIC Clinical Trials Group phase III clinical trials in Canada. Curr Oncol 2016;23(S1):S7-13.
Cavazza, M, Costa F, Jommi C. Organizzazione e gestione delle sperimentazioni cliniche. Milano: EGEA, 2016.
Regulation (EU) no. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
Cavazza M, Bertolani A, Jommi C. La ricerca clinica in Italia: quanto, come viene finanziata e i suoi effetti sul sistema. In: Gussoni G. (ed.). Il valore della ricerca clinica indipendente in Italia. Milano: EDRA, 2019.
Agenzia Italiana del Farmaco. L’uso dei farmaci in Italia. Rapporto OSMED, 2016.
Grossi F, Genova C, Gaitan ND et al. Free drugs in clinical trials and their potential cost saving impact on the National Health Service: a retrospective cost analysis in Italy. Lung Cancer 2013;81:236-40.
Spandonaro F, D’Angela D. Un caso studio sulla valutazione degli impatti generati dalle aziende farmaceutiche in una prospettiva pubblica. Roma: Centro Studi Crea Sanità, Università di Tor Vergata, 2015.
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Copyright (c) 2020 The authors
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors contributing to Global & Regional Health Technology Assessment agree to publish their articles under the CC-BY-NC 4.0 license, which allows third parties to re-use the work without permission as long as the work is properly referenced and the use is non-commercial.
Accepted 2020-04-22
Published 2020-06-16
