Analysis on Population Differences in Motivation of Healthy Subjects to Participate in Phase I Clinical Trials / 中国医学伦理学

ABSTRACT

【Objective:】 To understand the differences in motivation of different groups to participate in phase I clinical trials, and to provide suggestions for the recruitment and management of healthy subjects in research institutions, so as to improve the quality of clinical trials and protect the subjects’ rights and interests. 【Methods:】 Questionnaire survey was conducted among healthy subjects and potential community subjects in phase I clinical trials being carried out in a tertiary A hospital in Beijing from 2020 to 2021. SAS 9.2 was used for statistical analysis of data. 【 Results:】 There were many dimension differences between phase I ward subjects and community potential subjects in demographic and sociological characteristics, motivation to participate in the trials and influencing factors of motivation to participate in the experiment. Subjects in phase I ward paid more attention to the trial compensation, health care, social interaction and making friends, and the attitude of family or friends towards their participation in the trials. Community potential subjects were more concerned about trial quality, future potential benefits (contributing to the medical profession), and the impact on their own health and life. 【Conclusion:】 Research institutions should be aimed at different social background population stratification for recruitment, informed consent, personnel management system and the standard operating procedure, and pay attention to the subjects’ psychological and physiological needs from several aspects to standardize the management of subjects, improve the compliance of subjects to participate in the trial and the quality of clinical trials, and give more humanistic care and help to subjects.