Zejuan Wang1, Gang Chen1, Xiaona Liu1, Chen Liu2, Qingkun Song3, Jin Wang4. 1. Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, People's Republic of China. 2. Phase I Clinical Trial Centre, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Road, Haidian District, Beijing, 100038, People's Republic of China. 3. Department of Science and Technology, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Road, Haidian District, Beijing, 100038, People's Republic of China. 4. Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, People's Republic of China. wjlsq@sina.com.
Abstract
PURPOSE: To describe the motivations, barriers, and sociodemographic characteristics of healthy Chinese volunteers in phase I research and to demonstrate the factors influencing their willingness to participate in subsequent trials. METHODS: Healthy subjects who participated in seven phase I trials at two centres were invited to participate in the cross-sectional survey at discharge by anonymously and voluntarily completing the self-administered questionnaire. RESULTS: From 442 subjects asked to complete the questionnaire, a response rate of 94.8% (419) was obtained, and 72.8% of the respondents had participated in a mean of 2.0 ± 1.3 previous studies. Over 90% of the subjects indicated that the main motivations to participate trials were to help more people, to contribute to scientific research, and to obtain money. The top 5 barriers were time inconvenience, advertisement sources, potential risks associated with the drug, privacy, and the route of drug administration. Nearly half (49.6%) of the subjects were willing to participate in the next trial. The factors impacting the willingness of the subjects to participate in subsequent trials were gender, screening frequency, enrolment frequency, level of understanding of the research, two motivating factors (to make money and receive a free check-up), and ten barriers (e.g. risk, distance, living conditions, and trust). CONCLUSIONS: The majority of healthy Chinese subjects were young, were less well educated, had low income levels, and had poor medical insurance coverage. Given the multiple sources of motivation and complex barriers to trial participation, investigators and recruitment staff should consider ethics aspects to guarantee volunteer safety and well-being.
PURPOSE: To describe the motivations, barriers, and sociodemographic characteristics of healthy Chinese volunteers in phase I research and to demonstrate the factors influencing their willingness to participate in subsequent trials. METHODS: Healthy subjects who participated in seven phase I trials at two centres were invited to participate in the cross-sectional survey at discharge by anonymously and voluntarily completing the self-administered questionnaire. RESULTS: From 442 subjects asked to complete the questionnaire, a response rate of 94.8% (419) was obtained, and 72.8% of the respondents had participated in a mean of 2.0 ± 1.3 previous studies. Over 90% of the subjects indicated that the main motivations to participate trials were to help more people, to contribute to scientific research, and to obtain money. The top 5 barriers were time inconvenience, advertisement sources, potential risks associated with the drug, privacy, and the route of drug administration. Nearly half (49.6%) of the subjects were willing to participate in the next trial. The factors impacting the willingness of the subjects to participate in subsequent trials were gender, screening frequency, enrolment frequency, level of understanding of the research, two motivating factors (to make money and receive a free check-up), and ten barriers (e.g. risk, distance, living conditions, and trust). CONCLUSIONS: The majority of healthy Chinese subjects were young, were less well educated, had low income levels, and had poor medical insurance coverage. Given the multiple sources of motivation and complex barriers to trial participation, investigators and recruitment staff should consider ethics aspects to guarantee volunteer safety and well-being.