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

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.