Clinical trial through the eyes of patients: benefit or unjustified risk?
https://doi.org/10.47470/0044-197X-2021-65-2-118-124
Abstract
Introduction. Clinical trials (CTs) are the footing foundation of evidence-based medicine. In Russia many aspects of CT implementation remain unexplored; one of them is the attitude of Russian society.
Aims. This study aims to determine the knowledge and perception of CTs by potential participants. Analysis of the perception of CTs through the eyes of patients: CTs – is it a benefit or an unjustified risk?
Materials. The primary method of research was a questionnaire. A total of 488 anonymous, voluntary surveys of patients from hospitals in Tomsk were studied.
Results. More than half of the respondents heard about CTs, while the primary source of information was the media. The participants adequately assess the importance of conducting CTs to develop medicine and medical care for society. The primary goal of CTs is to determine the effectiveness and safety of drugs, and respondents regard their engagement as an opportunity to contribute to the development of science. The primary motivating factor in participating in CTs is receiving treatment for an incurable disease and observing conditions by a qualified doctor. The central negative aspect is the possibility of causing a risk to own health. The questionnaire demonstrated the need and importance of all points of informed consent. Several questions concerned the public attitude to researchers. According to patients, medical researchers arouse trust and confidence in altruistic motives during the CTs.
Conclusion. This study revealed a low interest of Russians in participating in CTs, except for personal benefit. The behavior of the doctors, the ability to convey reliable information to the patient to adequately assess benefits and possible risks play an important role in deciding on the involvement of patients in the CTs. The results of this work will allow us to adapt the process of organizing CTs to the needs of patients in the local context.
About the Authors
Olga I. ZvonarevaRussian Federation
Olga S. Kobyakova
Russian Federation
Igor’ D. Pimenov
Russian Federation
Maria Yu. Egorova
Russian Federation
Student of StrAU Integrative Approaches to Public Health and Healthcare, Siberian State Medical University, Tomsk, 634050, Russian Federation.
e-mail: egorova.m.u.egorova@ya.ru
Vera Е. Yun
Russian Federation
Dmitrij M. Loos
Russian Federation
Andrej V. Sofronov
Russian Federation
Stepan V. Zyrianov
Russian Federation
Anastasiya A. Bronnikova
Russian Federation
Denis S. Tyufilin
Russian Federation
Evgenij S. Kulikov
Russian Federation
References
1. DasMahapatra P., Raja P., Gilbert J., Wicks P. Clinical trials from the patient perspective: survey in an online patient community. BMC Health Serv. Res. 2017; 17(1): 166. https://doi.org/10.1186/s12913-017-2090-x
2. Almutairi A.F., Almutairi B.M., Alturki A.S., Adlan A.A., Salam M., Al-Jeraisy M.I., et al. Public motives and willingness to participate in first-in-humanclinical trials in Saudi Arabia: A new era in the making. J. Infect. Public Health. 2019; 12(5): 673–80. https://doi.org/10.1016/j.jiph.2019.03.013
3. Choi Y.J., Beck S.H., Kang W.Y., Yoo S., Kim S.Y., Lee J.S., et al. Knowledge and perception about clinical research shapes behavior: face to face survey in Korean General Public. J. Korean Med. Sci. 2016; 31(5): 674–81. https://doi.org/10.3346/jkms.2016.31.5.674
4. Burt T., Dhillon S., Sharma P., Khan D., Mv D., Alam S., et al. PARTAKE survey of public knowledge and perceptions of clinical research in India. PLoS One. 2013; 8(7): e68666. https://doi.org/10.1371/journal.pone.0068666
5. Adzhienko V.L. The attitude of patients to clinical trials and to their participation in them. Bioetika. 2008; (1): 21–6. (in Russian)
6. Google. Questionnaire «What I know about clinical trials?» Available at: https://goo.gl/forms/8JjPMS8D2X62pk9e2 (in Russian)
7. AOKI. What you should know about clinical trials. Available at: http://acto-russia.org/index.php?id=184&option=com_content&task=view (in Russian)
8. Fox S., Duggan M. Health Online; 2013. Available at: https://www.pewinternet.org/2013/01/15/health-online-2013/
9. Nimita L., Awani S. How social media is transforming pharma and healthcare: applied clinical trial. Appl. Clin. Trials. 2018; 27(2).
10. U.S. Department of Health & Human Services. New website: NIH Clinical Research Trials and You; 2012. Available at: https://www.nih.gov/health-information/nih-clinical-research-trials-you
11. CISCRP 2013 Perception & Insights Study Public and Patient Perceptions of Clinical Research; 2016.
12. Lee S.J., Park L.Ch., Lee J., Kim S., Choi M.K., Hong J.Y., et al. Unique perception of clinical trials by Korean cancer patients. BMC Cancer. 2012; 12: 594. https://doi.org/10.1186/1471-2407-12-594
13. Robinson E.J., Kerr C.E., Stevens A.J., Lilford R.J., Braunholtz D.A., Edwards S.J., et al. Lay public’s understanding of equipoise and randomisation in randomised controlled trials. Health Technol. Assess. 2005; 9(8): 1–192. https://doi.org/10.3310/hta9080
14. Falagas M.E., Korbila I.P., Giannopoulou K.P., Kondilis B.K., Peppas G. Informed consent: how much and what do patients understand? Am. J. Surg. 2009; 198(3): 420–35. https://doi.org/10.1016/j.amjsurg.2009.02.010
15. Parsons S., Starling B., Mullan-Jensen C. What the public knows and wants to know about medicines research and deve-lopment: a survey of the general public in six European countries. BMJ Open. 2015; 5(4): e006420. https://doi.org/10.1136/bmjopen-2014-006420
16. Melikhov O.G. What does the Russian population think about clinical trials? Remedium. 2007; (10): 10–3. (in Russian)
17. Schildmeijer K., Nilsen P., Ericsson C., Broström A., Skagerström J. Determinants of patient participation for safer care: A qualitative study of physicians’ experiences and perceptions. Health Sci. Rep. 2018; 1(10): e87. https://doi.org/10.1002/hsr2.87
18. Schilling I., Behrens H., Hugenschmidt C., Liedtke J., Schmiemann G., Gerhardus A. Patient involvement in clinical trials: motivation and expectations differ between patients and researchers involved in a trial on urinary tract infections. Res. Involv. Engagem. 2019; 5: 15. https://doi.org/10.1186/s40900-019-0145-3
19. Conradie A., Duys R., Forget P., Biccard B.M. Barriers to clinical research in Africa: a quantitative and qualitative survey of clinical researchers in 27 African countries. Br. J. Anaesth. 2018; 121(4): 813–21. https://doi.org/10.1016/j.bja.2018.06.013
20. Estcourt S., Epton J., Epton T., Vaidya B., Daly M. Exploring the motivations of patients with type 2 diabetes to participate in clinical trials: a qualitative analysis. Res. Involv. Engagem. 2016; 2: 34. https://doi.org/10.1186/s40900-016-0050-y
21. Sacristán J.A., Aguarón A., Avendaño-Solá C., Garrido P., Carrión J., Gutiérrez A., et al. Patient involvement in clinical research: why, when, and how. Patient Prefer. Adherence. 2016; 10: 631–40. https://doi.org/10.2147/ppa.s104259
22. Nappo S.A., Iafrate G.B., Sanchez Z.M. Motives for participating in a clinical research trial: a pilot study in Brazil. BMC Public. Health. 2013; 13: 19. https://doi.org/10.1186/1471-2458-13-19
23. Kass N.E., Taylor H.A., Ali J., Hallez K., Chaisson L. A pilot study of simple interventions to improve informed consent in clinical research: Feasibility, approach, and results. Clin. Trials. 2015; 12(1): 54–66. https://doi.org/10.1177/1740774514560831
24. Nishimura A., Carey J., Erwin P.J., Tilburt J.C., Murad M.H., McCormick J.B. Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials. BMC Med. Ethics. 2013; 14: 28. https://doi.org/10.1186/1472-6939-14-28
25. Wendler D. «Targeted» consent for pragmatic clinical trials. J. Gen. Intern. Med. 2015; 30(5): 679–82. https://doi.org/10.1007/s11606-014-3169-2
26. Spellecy R., Leuthner S., Farrell M. Risk, respect for persons, and informed consent in comparative effectiveness research. Am. J. Bioeth. 2013; 13(12): 46–8. https://doi.org/10.1080/15265161.2013.851299
27. Anderson E.E., Newman S.B., Matthews A.K. Improving informed consent: Stakeholder views. AJOB Empir. Bioeth. 2017; 8(3): 178–88. https://doi.org/10.1080/23294515.2017.1362488
28. El Obaid Y., Al Hamiz A., Abdulle A., Hayes R.B., Sherman S., Ali R. Perceptions and attitudes towards medical research in the United Arab Emirates: Results from the Abu Dhabi Cohort Study (ADCS) focus group discussions. PloS One. 2016; 11(3): e0149609. https://doi.org/10.1371/journal.pone.0149609
Review
For citations:
Zvonareva O.I., Kobyakova O.S., Pimenov I.D., Egorova M.Yu., Yun V.Е., Loos D.M., Sofronov A.V., Zyrianov S.V., Bronnikova A.A., Tyufilin D.S., Kulikov E.S. Clinical trial through the eyes of patients: benefit or unjustified risk? Health care of the Russian Federation. 2021;65(2):118-124. (In Russ.) https://doi.org/10.47470/0044-197X-2021-65-2-118-124