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.
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Data availability
The datasets generated and/or analysed during this study are available from the corresponding author on reasonable request.
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Acknowledgements
The authors thank the participants for their responses to the survey, the research staff at the Beijing Shijitan Hospital and the Aerospace Center Hospital for their invaluable support with regard to collecting and entering the data. The opinions expressed are those of the authors.
Funding
This research was funded by the Beijing Shijitan Hospital Funds (2014-C20), which helped pay for materials and training.
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All authors contributed to the study conception and design, especially Jin Wang and Gang Chen. Material preparation and data collection were performed by Xiaona Liu and Chen Liu, and the analysis was performed by Gang Chen and Qingkun Song. The first draft of the manuscript was written by Zejuan Wang, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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This study was reviewed by the Ethics Committee of the Beijing Shijitan Hospital (Beijing, China) and approved as a non-interventional study (2014-C20).
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Wang, Z., Chen, G., Liu, X. et al. The motivations, barriers, and sociodemographic characteristics of healthy Chinese volunteers in phase I research. Eur J Clin Pharmacol 77, 557–568 (2021). https://doi.org/10.1007/s00228-020-03040-6
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DOI: https://doi.org/10.1007/s00228-020-03040-6