Clinical trials: their contribution to the efficiency of the clinical management of rheumatoid arthritis

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Abstract

Background: This article presents a descriptive analysis of our Clinical Research Unit (CRU) at the Rheumatology Department in the University and Polytechnic Hospital La Fe (RD-UPH La Fe), Valencia (Spain), as well as an estimation of the economic impact of conducting clinical trials for the Spanish Health System in terms of avoided costs.

Methods: During the period 2011–2015, a retrospective observational study was conducted based on the trials performed in our CRU, along with a cost analysis from the health authority perspective.

Results: Most of the trials conducted during this period were phase III studies in patients with rheumatic disorders, particularly rheumatoid arthritis. An economic evaluation study showed that the implementation of these studies in our CRU resulted in an annual saving of €13,935.30 per patient.

Conclusion: Our CRU is an efficacy and efficiency tool for cost saving in the healthcare system.

Keywords: Clinical research, cost analysis, impact on healthcare, rheumatic disease, rheumatoid arthritis.

Citation: Alcañiz Escandell CP, Román Ivorra JA. Clinical trials: their contribution to the efficiency of the clinical management of rheumatoid arthritis. Drugs in Context 2019; 8: 212612. DOI: 10.7573/dic.212612

Contributions: All authors contributed extensively to the work presented in this paper. All authors have contributed significantly to the conception, design, or acquisition of data, or analysis and interpretation of data. All authors have participated in drafting, reviewing, and/or revising the manuscript and have approved its submission. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: Dr Román Ivorra reports that he is on advisory boards for Pfizer, Sanofi, and Roche, outside the submitted work. No conflicts of interest exist concerning the conduct of this work. Etanercept was chosen as a therapeutic alternative based on cost efficacy/cost-effectiveness criteria, regardless of the pharmaceutical company marketing the drug. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at https://www.drugsincontext.com/wp-content/uploads/2019/11/dic.212612-COI.pdf

Acknowledgements: Editorial assistance was provided by Content Ed Net (Madrid, Spain).

Funding declaration: Editorial assistance was funded by an unrestricted grant from Merck Sharp & Dohme Spain. The study was not funded by any external sources.

Copyright: Copyright © 2019 Alcañiz Escandell CP, Román Ivorra JA. https://doi.org/10.7573/dic.212612. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2019 Alcañiz Escandell CP, Román Ivorra JA. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/clinical-trials:-their-contribution-to-the-efficiency-of-the-clinical-management-of-rheumatoid-arthritis/

Correspondence: José A Román Ivorra, Department of Rheumatology, Hospital Universitari i Politécnic la Fe, Valencia, Spain. roman_jan@gva.es

Provenance: submitted; externally peer reviewed.

Submitted: 18 July 2019; Peer review comments to author: 23 August 2019; Revised manuscript received: 11 November 2019; Accepted: 18 November 2019; Publication date: 23 December 2019.

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