ECONOMIC FACTORS OF CLINICAL TRIALS OF MEDICINES IN SMALL POPULATION COUNTRIES: CASE STUDY OF LATVIA
DOI:
https://doi.org/10.17770/sie2021vol4.6143Keywords:
clinical trials, economic factors of clinical trials, small population countries. JEL classification, I19, M29Abstract
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.
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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