TY - JOUR
T1 - Clinical trial through the eyes of patients
T2 - Benefit or unjustified risk?
AU - Zvonareva, Olga I.
AU - Kobyakova, Olga S.
AU - Pimenov, Igor' D.
AU - Egorova, Maria Yu
AU - Yun, Vera E.
AU - Loos, Dmitrij M.
AU - Sofronov, Andrej V.
AU - Zyrianov, Stepan V.
AU - Bronnikova, Anastasiya A.
AU - Tyufilin, Denis S.
AU - Kulikov, Evgenij S.
N1 - Funding Information:
For correspondence: Maria Yu. Egorova, student of StrAU Integrative Approaches to Public Health and Healthcare, Siberian State Medical University, Tomsk, 634050, Russian Federation. E-mail: [email protected] Information about the authors: Zvonareva O.I., https://orcid.org/0000-0001-5548-7491; Kobyakova O.S., https://orcid.org/0000-0003-0098-1403 Pimenov I.D., https://orcid.org/0000-0003-3866-100X; Egorova M.Yu., https://orcid.org/0000-0003-3603-4774 Yun V.E., https://orcid.org/0000-0002-9127-8619; Loos D.M., https://orcid.org/0000-0002-4098-6076 Sofronov A.V., https://orcid.org/0000-0001-8636-6481; Zyrianov S.V., https://orcid.org/0000-0002-1352-6517 Bronnikova A.A., https://orcid.org/0000-0002-8981-0821; Tyufilin D.S., https://orcid.org/0000-0002-9174-6419 Kulikov E.S., https://orcid.org/0000-0002-0088-9204 Contribution of the authors: Zvonareva O.I. – the concept and design of the study, statistical analysis, editing; Kobyakova O.S., Kulikov E.S. – the concept and design of the study, editing; Pimenov I.D. – the concept and design of the study, statistical analysis, writing the text; Egorova M.Y., Yun V.E. – the concept and design of the study, the collection and processing of the material, writing the text; Loos D.M., Sofronov A.V., Zyrianov S.V., Bronnikova A.A. – the collection and processing of the material; Tyufilin D.S. – statistical analysis, editing. All co-authors – approval of the final version of the article, responsibility for the integrity of all parts of the article. Acknowledgments. The study was supported by a grant from the Russian Science Foundation (project ? 18-78-10016). Conflict of interest. The authors declare no conflict of interest.
Publisher Copyright:
© 2021 Izdatel'stvo Meditsina. All rights reserved.
PY - 2021/1/1
Y1 - 2021/1/1
N2 - 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.
AB - 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.
KW - Attitude to researchers
KW - Clinical research
KW - Informed consent
KW - Patients' motivation
KW - Public attitude
U2 - 10.47470/0044-197X-2021-65-2-118-124
DO - 10.47470/0044-197X-2021-65-2-118-124
M3 - Article
SN - 0044-197X
VL - 65
SP - 118
EP - 124
JO - Health Care of the Russian Federation
JF - Health Care of the Russian Federation
IS - 2
ER -