Clinical trial through the eyes of patients: benefit or unjustified risk?

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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.

Sobre autores

Olga Zvonareva

Maastricht University; Siberian State Medical University

Autor responsável pela correspondência
Email: noemail@neicon.ru
ORCID ID: 0000-0001-5548-7491
Rússia

Olga Kobyakova

Siberian State Medical University

Email: noemail@neicon.ru
ORCID ID: 0000-0003-0098-1403
Rússia

Igor’ Pimenov

Siberian State Medical University

Email: noemail@neicon.ru
ORCID ID: 0000-0003-3866-100X
Rússia

Maria Egorova

Siberian State Medical University

Email: egorova.m.u.egorova@ya.ru
ORCID ID: 0000-0003-3603-4774

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

Rússia

Vera Yun

Siberian State Medical University

Email: noemail@neicon.ru
ORCID ID: 0000-0002-9127-8619
Rússia

Dmitrij Loos

Siberian State Medical University

Email: noemail@neicon.ru
ORCID ID: 0000-0002-4098-6076
Rússia

Andrej Sofronov

Siberian State Medical University

Email: noemail@neicon.ru
ORCID ID: 0000-0001-8636-6481
Rússia

Stepan Zyrianov

Siberian State Medical University

Email: noemail@neicon.ru
ORCID ID: 0000-0002-1352-6517
Rússia

Anastasiya Bronnikova

Siberian State Medical University

Email: noemail@neicon.ru
ORCID ID: 0000-0002-8981-0821
Rússia

Denis Tyufilin

Siberian State Medical University

Email: noemail@neicon.ru
ORCID ID: 0000-0002-9174-6419
Rússia

Evgenij Kulikov

Siberian State Medical University

Email: noemail@neicon.ru
ORCID ID: 0000-0002-0088-9204
Rússia

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Declaração de direitos autorais © Zvonareva O.I., Kobyakova O.S., Pimenov I.D., Egorova M.Y., Yun V.Е., Loos D.M., Sofronov A.V., Zyrianov S.V., Bronnikova A.A., Tyufilin D.S., Kulikov E.S., 2021

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