MOTIVATIONAL FACTORS OF PATIENT PARTICIPATION IN CLINICAL TRIALS IN UKRAINE UNDER THE CONDITIONS OF THE MARTIAL STATE
DOI:
https://doi.org/10.32999/ksu2307-8030/2024-51-7Keywords:
clinical research, clinical trials, innovative medicines, clinical trial subjects, patients, prognostication, patient safety, clinical trial protocolAbstract
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.
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