MOTIVATIONAL FACTORS OF PATIENT PARTICIPATION IN CLINICAL TRIALS IN UKRAINE UNDER THE CONDITIONS OF THE MARTIAL STATE
Abstract
The article examines the motivational factors that contribute to increasing patient involvement in clinical research (trials) in Ukraine under the conditions of the martial state. It examines the problem of insufficient patient participation in clinical trials in Ukraine and globally. In order to determine the set of motivational factors to increase the interest of patients in participating in clinical trials and taking into account the state and development of such trials in Ukraine under the conditions of the martial state, a survey of respondents was conducted on the attitude of the Ukrainian population to clinical trials; a scheme of relations between key clinical trial participants was developed with an emphasis on the relationship of each of them with patients in clinical trials. Based on the survey results was determined the level of public awareness about clinical trials in Ukraine (82% of respondents are familiar with clinical trials, while 6% are not), Attitudes toward clinical trials are assessed (64% of respondents view them positively, 28% are cautious, and 3% are negative), as well as the willingness to participate (13% express willingness, 55% under certain conditions, and 27% decline participation). According to the survey results, 68% of respondents are concerned about the unclear effect of drugs on the patient's body during clinical trials, 13% of respondents are concerned about insufficient legal protection of patients participating in clinical trials. The results of the study show that the defining provisions of the mechanism for increasing the motivation of the population to participate in clinical trials are: interaction between the key subjects of clinical trials (sponsor – investigator – patient – regulatory authority); regulatory regulation and guaranteeing the conditions for the safety of patient participation in a clinical trial in accordance with the trial protocol, legal protection of the rights of such a patient; forecasting the development of clinical trials in accordance with a particular disease with justification of its. Attention is focused on the peculiarities of conducting clinical research in Ukraine under the conditions of the martial state, in particular, the relocation of Clinical Research Centers and patients to the western regions of Ukraine and abroad.
References
1. Fogel D. (2018) Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: а review. Contemp Clin Trials Commun, pp. 156–164. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/ (accessed February 1, 2024).
2. Feller S. (2015) One in Four Cancer Trials Fails to Enroll Enough Participants. Health News. Available at: https://www.upi.com/Health_News/2015/12/30/One-in-four-cancer-trials-fails-to-enroll-enough-participants/2611451485504/ (accessed February 1, 2024).
3. McDonald A. et al. (2006) What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. Available at: https://europepmc.org/article/pmc/pmc1475627 (accessed February 1, 2024).
4. Chhatre S. et al. (2018) Patient-centered recruitment and retention for a randomized controlled study. Trials. DOI: https://doi.org/10.1186/s13063-018-2578-7. (accessed February 1, 2024).
5. McGill K. et al. (2020) A systematic review of the efficiency of recruitment to stroke rehabilitation randomised controlled trials. Trials, no. 21. DOI: https://doi.org/10.1186/s13063-019-3991-2 (accessed February 1, 2024).
6. Uchast patsiientiv z Ukrainy v klinichnykh doslidzhenniakh, yaki provodiatsia v Polshchi: rekomendatsii v haluzi klinichnykh doslidzhen [Participation of patients from Ukraine in clinical trials conducted in Poland]: recommendations in the field of clinical trials. Available at: http://surl.li/jrxnad (accessed February 1, 2024). (in Ukrainian)
7. Kandi V., Vadakedath S. (2021) Clinical Research: An Overview of study Types, Designs, and Their Implications in the Health Perspective. American Journal of Clinical Medicine Research. DOI: https://doi.org/10.12691/ajcmr-9-2-1 (accessed February 1, 2024).
8. Gelband H. A. (1999) Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms. Washington (DC): National Academies Press (US); Common Elements of Clinical Trial Review Criteria. Available at: https://www.ncbi.nlm.nih.gov/books/NBK224010/ (accessed February 1, 2024).
9. Farrell B., Kenyon S. (2018) Effectively managing clinical trials: the Guide to Efficient Trial Management. London: National Institute for Health Research: Queen’s Printer and Controller of HMSO. 60 p.
10. Farrell B., Kenyon S. & Shakur, H. (2010) Managing clinical trials. Trials, no. 11(1). Available at: https://pubmed.ncbi.nlm.nih.gov/20626885/ (accessed February 1, 2024).
11. Schumacher A., Sikov W. M., Quesenberry M. I., Safran H., Khurshid H., Mitchell K. M. et al. (2017) Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS ON, no. 12(2). DOI: https://doi.org/10.1371/journal.pone.0172957 (accessed February 1, 2024).
12. Ramana K. V., Kandi S. Boinpally P.R. (2013) Ethics in medical education, practice, and research: An insight. Ann Trop Med Public Health, no. 6, pp. 599–602.
13. Liu B., Zhu L., Zou J. et al. (2021) Updated methodology for projecting U.S.‐ and state‐level cancer counts for the current calendar year. Part I: spatio‐temporal modeling for cancer incidence. Cancer Epidemiol Biomarkers Prev, no. 30(9), pp. 1620–1626. DOI: https://doi.org/10.1158/1055-9965.EPI-20-1727 (accessed February 1, 2024).
14. Miller K. D., Siegel R. L., Liu B. et al. (2021) Updated methodology for projecting U.S.‐ and state‐level cancer counts for the current calendar year. Part II: evaluation of incidence and mortality projection methods. Cancer Epidemiol Biomarkers Prev, no. 30(11). DOI: https://doi.org/10.1158/1055‐9965.epi‐20‐1780 (accessed February 1, 2024).
15. Shrider E. A., Creamer J. (2023) Poverty in the United States: 2022. Current Population Reports. US Census Bureau, US Department of Commerce, рр. 60–280.
16. Nguyen B. T., Han X., Jemal A., Drope, J. (2016) Diet quality, risk factors and access to care among low-income uninsured American adults in states expanding Medicaid vs. states not expanding under the Affordable Care Act. Prev Med, Aug 8, рр. 169–171. DOI: https://doi.org/10.1016/j.ypmed.2016.08.015. (accessed February 1, 2024).
17. Denhoff E. R., Milliren C. E., de Ferranti S. D., Steltz S. K., Osganian S. K. (2015) Factors Associated with Clinical Research Recruitment in a Pediatric Academic Medical Center--A Web-Based Survey. PLoS One. DOI: https://doi.org/10(10):e0140768. (accessed February 1, 2024).
18. Yi D., Ma D., Li G., Zhou L., Xiao Q., Zhang. Y. et al. (2015) Statistical Use in Clinical Studies: Is There Evidence of a Methodological Shift? PLoS ONE. DOI: https://doi.org/10(10):e0140159. (accessed February 1, 2024).
19. Nabir patsiientiv dlia klinichnykh doslidzhen (2023): informatsiia Derzhavnoho Ekspertnoho Tsentru MOZ Ukrainy [Recruitment of patients for clinical research (2023): information of the State Expert Center of the Ministry of Health of Ukraine.]. Available at: https://uacr.org/images/materials_from_Polish_colleagues/1_Planowanie_rekrutacji_ukr.pdf (accessed February 1, 2024). (in Ukrainian)
20. Tohid H., Choudhury S. M., Agouba S., et al. (2017) Perceptions and attitudes to clinical research participation in Qatar. Contemp Clin Trials Commun, no. 8, pp. 241-247.
21. Informatsiina dovidka pro stan klinichnykh vyprobuvan v Ukraini u period z 01.01.2023 po 31.12.2023 (2024) [Information certificate on the state of clinical trials in Ukraine in the period from 01.01.2023 to 31.12.2023 (2024)] : information from the State Expert Center of the Ministry of Health of Ukraine Available at: https://www.dec.gov.ua/wp-content/uploads/2024/01/informaczijna-dovidka-kv-ka-2023.pdf (accessed February 1, 2024). (in Ukrainian)
22. Shiyan N. I., Prokhorenko O. V. (February 13–14, 2024) Osoblyvosti rozvytku menedzhmentu klinichnykh doslidzhen [Features of the development of clinical research management]. Proceedings of the Integrated strategic management, management of portfolios, programs, projects: theses of reports of HIV International. science and practice conference (eds. by Prof. Kononenko I. V.). Kharkiv: NTU "KhPI", pp. 60–61. Available at: https://repository.kpi.kharkov.ua/items/b771e881-f611-4b50-b577-e55c843ef056 (accessed March 14, 2024). (in Ukrainian)
23. Pro zatverdzhennia Poriadku provedennia klinichnykh vyprobuvan likarskykh zasobiv ta ekspertyzy materialiv klinichnykh vyprobuvan i Typovoho polozhennia pro komisii z pytan etyky: nakaz Ministerstva okhorony zdorovia vid 23.09.2009 № 690 (iz zminamy i dopovnenniamy) [On the approval of the Procedure for conducting clinical trials of medicinal products and the examination of clinical trial materials and the Standard Regulations on ethics commissions]. Available at: https://zakon.rada.gov.ua/laws/show/z1010-09#Text (accessed February 1, 2024). (in Ukrainian)
24. Rezultaty diialnosti z pytan bezpeky likarskykh zasobiv (2023) [Results of activities on the safety of medicinal products] : information of the State Expert Center of the Ministry of Health of Ukraine. Available at: https://www.dec.gov.ua/patient/rezultati-diyalnosti-z-pitan-bezpeki-likarskih-zasobiv/?role=patient (accessed February 1, 2024). (in Ukrainian)
25. Zvity pro doklinichni doslidzhennia ta klinichni vyprobuvannia (2023) [Reports on preclinical studies and clinical trials] : information of the State Expert Center of the Ministry of Health of Ukraine. Available at: https://www.dec.gov.ua/ua/zvity-pro-doklinichni-doslidzhennya-ta-klinichni-vyprobuvannya/ (accessed February 1, 2024). (in Ukrainian)
26. Pro dostup do publichnoi informatsii [On access to public information] : Law of Ukraine dated January 13, 2011 No. 2030-VI (as amended). Available at: https://minjust.gov.ua/m/str_35409 (accessed February 1, 2024). (in Ukrainian)