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Research article
Clinical trials and drug cost savings for Italian Health Service
Alessandro Morabito
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1319-9608
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Health Services Research.
Background: The cost of anticancer drugs is constantly growing. The aim of this study was determine the impact in terms of cost reduction for anticancer drug in the Italian Health Service due to patient participation in clinical trials.
Methods: We evaluated the cost of drugs administered to patients treated in clinical trials at the National Cancer Institute of Naples in a four-week time period. Patients with a diagnosis of different cancers were considered, including adjuvant therapy and treatment for advanced disease, pharma sponsored and investigator initiated phase I, II and III clinical studies. We defined the expected standard treatment for each patient and we calculated the cost of the standard antineoplastic drugs that should be administered in clinical practice outside clinical trials. We used the market price of drugs to determine the cost savings value. Costs other than drugs were not included in the cost saving calculation.
Results: From 23.10.2017 to 17.11.2017, 126 patients were treated in 34 pharma sponsored and investigator initiated clinical trials, using experimental drugs provided free of charge by the sponsors, for an overall number of 152 cycles of therapy. If these patients were treated with conventional therapies in clinical practice the cost of antineoplastic drugs would account for 517,658 Euros, with an average of 5,487 Euros saved per patients for a period of four weeks.
Conclusions: Clinical trials with investigational antineoplastic drugs provided free of charge by Sponsors render considerable cost savings, with a tangible benefit in clinical and administrative strategies to reduce drug expenditures.
Keywords
clinical trials, cost savings, treatment costs, investigational drug, per-patient cost, drugs expenditure, cost reduction
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CURRENT STATUS: Published
Version 2
Posted 25 Sep, 2020
Published
On 26 Nov, 2020
Published
On 26 Nov, 2020
No community comments so far
Editorial decision: Accept
On 12 Nov, 2020
Review #2 received
Received 28 Oct, 2020
Reviewer #2 agreed
On 05 Oct, 2020
Reviewers invited
Invitations sent on 01 Oct, 2020
Reviewer #1 agreed
On 01 Oct, 2020
Review #1 received
Received 01 Oct, 2020
Editor assigned
On 23 Sep, 2020
Submission checks complete
On 22 Sep, 2020
Editor invited
On 22 Sep, 2020
No comments provided
Editorial decision: Major revision
On 30 Aug, 2020
Review #1 received
Received 28 Aug, 2020
Review #2 received
Received 19 Aug, 2020
Reviewer #4 agreed
On 07 Aug, 2020
Reviewer #3 agreed
On 05 Jul, 2020
Reviewers invited
Invitations sent on 30 Jun, 2020
Reviewer #1 agreed
On 30 Jun, 2020
Reviewer #2 agreed
On 30 Jun, 2020
First submitted
On 21 Jun, 2020
Editor assigned
On 21 Jun, 2020
Submission checks complete
On 20 Jun, 2020
Editor invited
On 20 Jun, 2020
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This preprint is under consideration at BMC Health Services Research. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Clinical trials and drug cost savings for Italian Health Service
Alessandro Morabito
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1319-9608
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 25 Sep, 2020
Published
On 26 Nov, 2020
Published
On 26 Nov, 2020
No community comments so far
Editorial decision: Accept
On 12 Nov, 2020
Review #2 received
Received 28 Oct, 2020
Reviewer #2 agreed
On 05 Oct, 2020
Reviewers invited
Invitations sent on 01 Oct, 2020
Reviewer #1 agreed
On 01 Oct, 2020
Review #1 received
Received 01 Oct, 2020
Editor assigned
On 23 Sep, 2020
Submission checks complete
On 22 Sep, 2020
Editor invited
On 22 Sep, 2020
No comments provided
Editorial decision: Major revision
On 30 Aug, 2020
Review #1 received
Received 28 Aug, 2020
Review #2 received
Received 19 Aug, 2020
Reviewer #4 agreed
On 07 Aug, 2020
Reviewer #3 agreed
On 05 Jul, 2020
Reviewers invited
Invitations sent on 30 Jun, 2020
Reviewer #1 agreed
On 30 Jun, 2020
Reviewer #2 agreed
On 30 Jun, 2020
First submitted
On 21 Jun, 2020
Editor assigned
On 21 Jun, 2020
Submission checks complete
On 20 Jun, 2020
Editor invited
On 20 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Health Services Research.
Background: The cost of anticancer drugs is constantly growing. The aim of this study was determine the impact in terms of cost reduction for anticancer drug in the Italian Health Service due to patient participation in clinical trials.
Methods: We evaluated the cost of drugs administered to patients treated in clinical trials at the National Cancer Institute of Naples in a four-week time period. Patients with a diagnosis of different cancers were considered, including adjuvant therapy and treatment for advanced disease, pharma sponsored and investigator initiated phase I, II and III clinical studies. We defined the expected standard treatment for each patient and we calculated the cost of the standard antineoplastic drugs that should be administered in clinical practice outside clinical trials. We used the market price of drugs to determine the cost savings value. Costs other than drugs were not included in the cost saving calculation.
Results: From 23.10.2017 to 17.11.2017, 126 patients were treated in 34 pharma sponsored and investigator initiated clinical trials, using experimental drugs provided free of charge by the sponsors, for an overall number of 152 cycles of therapy. If these patients were treated with conventional therapies in clinical practice the cost of antineoplastic drugs would account for 517,658 Euros, with an average of 5,487 Euros saved per patients for a period of four weeks.
Conclusions: Clinical trials with investigational antineoplastic drugs provided free of charge by Sponsors render considerable cost savings, with a tangible benefit in clinical and administrative strategies to reduce drug expenditures.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5