ECONOMIC FACTORS OF CLINICAL TRIALS OF MEDICINES IN SMALL POPULATION COUNTRIES: CASE STUDY OF LATVIA

Authors

  • Māra Pētersone Riga Technical University
  • Dainis Krieviņš Paula Stradina Clinical University Hospital
  • Kārlis Ketners BA School of Business and Finance
  • Ona Gražina Rakauskienė Mykolas Romeris University

DOI:

https://doi.org/10.17770/sie2021vol4.6143

Keywords:

clinical trials, economic factors of clinical trials, small population countries. JEL classification, I19, M29

Abstract

The clinical trial process has become a significant type of services that provides huge added value to any national economy. Undoubtedly, the primary group of stakeholders in clinical trials of medicines is pharmaceutical companies that obtain a product as a result of successful clinical trials. However, other groups involved will also obtain materials and intangible benefits from the process of clinical trials of medicines. In this context, the authors tended to find out: What are considered to be the primary economic benefits of clinical trials of medicines in a society with small population? Aim of the research is to analyse economic factors of clinical trials of medicines in countries with small population, taking Latvia as an example. Object of the research: economic factors of clinical trials of medicines. The principle of snowball has been used to make the selection of the participants' survey. The empirical analysis and evaluation of economic factors in unique clinical trials of medicines are based on the qualitative research method of semi-structured individual (in-depth) interviews. According to the survey, the most important economic type of clinical trials of medicinal products in Latvia is “socioeconomic factors”, the average index of the factor being 0.82. The most significant three categories of the socioeconomic factors are “Access to the latest treatment methods and preparations” (Index max 1), “Improved patient care (time used per patient)” (Index 0.87) and “Exchange of experience, transfer of knowledge on the most innovative treatment methods” (Index 0.86). Society with small population values the primary economic benefits from clinical trials of medicines. It can be concluded that the socioeconomic factor is the most significant, compared to the direct economic factor and the alternative cost savings factor.

 

Downloads

Download data is not yet available.

Author Biographies

  • Māra Pētersone, Riga Technical University
    Assistant professor and senior researcher at Riga Technical University in a postdoctoral project “IMPACT OF PUBLIC SECTOR REFORMS ON PERFORMANCE MANAGEMENT IMPROVEMENT IN CLINICAL UNIVERSITY HOSPITALS”. Her e-mail address is : mara.petersone@rtu.lv and her Web-page can be found athttps://www.rtu.lv/lv/zinatne/pecdoktorantura/pecdoktoranturas-petniecibas-projekti#IEVF
  • Dainis Krieviņš, Paula Stradina Clinical University Hospital
    Professor at the University of Latvia;Corresponding Member of the Latvian Academy of Sciences;Director of the Scientific Institute of P. Stradiņš Clinical University Hospital
  • Kārlis Ketners, BA School of Business and Finance
    Professor of the Department of Finance of the BA School of Business and Finance: Director of Budget Policy Development Department at Ministry of Finance of Latvia; Former State Secretary of Ministry of Health of the Republic of Latvia.
  • Ona Gražina Rakauskienė, Mykolas Romeris University
    Habil. Dr., Professor of the Economics and Business Faculty at Mykolas Romeris University. Head of  Life Quality Laboratory at Mykolas Romeris University.

References

Abdel-Kader, K., & Jhamb, M. (2020). EHR-based clinical trials: The next generation of evidence. Clinical Journal of the American Society of Nephrology, 15(7), 1050–1052. https://doi.org/10.2215/CJN.11860919

Cabinet of Ministers. (2018). Procedures for the Organization and Payment of Health Services. Retrieved from http://likumi.lv/ta/id/301399-veselibas-aprupes-pakalpojumu-organizesanas-un-samaksas-kartiba

DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20–33. https://doi.org/10.1016/j.jhealeco.2016.01.012

EU Clinical Trials Register. (2020). Clinical trials. Retrieved from https://www.clinicaltrialsregister.eu/ctr-search/search?query=&country=lv

Kalashnikov, V. (2004). Provedenie kliniko - jekonomicheskih issledovanij: neobhodimost' ili dan' mode. Kachestvennaja klinicheskaja praktika, (1), 34-38.

Kramer, J. M. &Schulman, K. A. (2012). Transforming the economics of clinical trials. In Institute of Medicine (US) (Ed.), Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020. National Academies Press (US).

Lin, A. A., Sokolov, B. I., & Orlov, A. S. (2015). Farmacevticheskij rynok: segment klinicheskih issledovanij lekarstvennyh preparatov. Problemy sovremennoj jekonomiki, 1 (53).

Logviss, K., Krievins, D., & Purvina, S. (2018). Characteristics of clinical trials in rare vs. common diseases: A register-based Latvian study. PLoS ONE, 13(4). https://doi.org/10.1371/journal.pone.0194494

Melihov, O. G. (2006). Mezhdunarodnyj rynok klinicheskih issledovanij: problemy i perspektivy. Remedium. Zhurnal o rossijskom rynke lekarstv i medicinskoj tehnike, (6).

Petitti, D. B. (2009). Meta-Analysis, Decision Analysis, and Cost-Effectiveness Analysis. Meta-Analysis, Decision Analysis, and Cost-Effectiveness Analysis. Oxford University Press. https://doi.org/10.1093/acprof:oso/9780195133646.001.0001

Pinto, E. M., Willan, A. R., & O’Brien, B. J. (2005). Cost-effectiveness analysis for multinational clinical trials. Statistics in Medicine, 24(13), 1965–1982. https://doi.org/10.1002/sim.2078

PwC. (2020). Clinical Trials in Poland– Key Challenges. Retrieved from https://www.pwc.com/gx/en/pharma-life-sciences/assets/clinical-trials-in-poland-2010.pdf

Ramsey, S. D., Willke, R. J., Glick, H., Reed, S. D., Augustovski, F., Jonsson, B., … Sullivan, S. D. (2015). Cost-effectiveness analysis alongside clinical trials II - An ISPOR good research practices task force report. Value in Health, 18(2), 161–172. https://doi.org/10.1016/j.jval.2015.02.001

Sakamaki, K., Yoshida, S., Morita, Y., Kamiura, T., Iba, K., Ogawa, N., … Fukimbara, S. (2020). Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in Japan. Therapeutic Innovation and Regulatory Science, 54(3), 528–533. https://doi.org/10.1007/s43441-019-00084-4

Strizrep, T.; Alaka, H. (2016). Provider Payment Review. Support to Develop Health System Strategy for Priority Disease Areas in Latvia. Retrieved from http://www.vmnvd.gov.lv/uploads/files/5746b6050a182.pdf

The European Federation of Pharmaceutical Industries and Associations. (2020). The Pharmaceutical Industry in Figures. Retrieved from https://www.efpia.eu/media/412931/the-pharmaceutical-industry-in-figures-2019.pdf

The State Agency of Medicines of Latvia A. (2020). Public Overview for 2011-2018. Retrieved from https://www.zva.gov.lv/lv/par-mums/par-agenturu/zva-gada-publiskais-parskats/arhivs

The State Agency of Medicines of Latvia B. (2020). Data from 2001 to 2019.

Thiers, F. A., Sinskey, A. J., & Berndt, E. R. (2008). Trends in the globalization of clinical trials. Nature Reviews Drug Discovery, 7(1), 13–14. https://doi.org/10.1038/nrd2441

Yang, H., & Lee, H. J. (2018). Long-term collaboration network based on clinicaltrials.gov database in the pharmaceutical industry. Sustainability (Switzerland), 10(2), 1–14. https://doi.org/10.3390/su10020322

Downloads

Published

2021-05-28

How to Cite

Pētersone, M., Krieviņš, D., Ketners, K., & Rakauskienė, O. G. (2021). ECONOMIC FACTORS OF CLINICAL TRIALS OF MEDICINES IN SMALL POPULATION COUNTRIES: CASE STUDY OF LATVIA. SOCIETY. INTEGRATION. EDUCATION. Proceedings of the International Scientific Conference, 4, 428-438. https://doi.org/10.17770/sie2021vol4.6143