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Aim: The aim of this study is to assess the willingness, motivation, satisfaction levels, and expectations of participants engaged in clinical trials, while also exploring factors that influence compliance from the participants' standpoint. Furthermore, this research aims to enhance the understanding of all stakeholders involved in clinical trials about the needs of participants and to offer evidence-based and pragmatic recommendations for effectively managing clinical trial participants. Methods: An electronic questionnaire covers various aspects of Traditional Chinese Medicine (TCM) clinical trials. The distribution of the electronic questionnaire was facilitated through WeChat groups, WeChat Moments, and individual interactions. Count data was expressed in terms of frequency (or rate), and subsequent analysis was conducted utilizing the standard chi-squared test. A p value≤ 0.05 was considered significant. By drawing a Pareto chart, the priority of factors influencing participants' willingness to participate in clinical trials was systematically assessed. Results: 88 participants answered the questionnaire. A decline in education level corresponded to a decreasing comprehension of participants' grasp of "clinical trial" and "clinical trial participant" (p< 0.05). The primary reason for participants' reservations about joining clinical trials stems from their inadequate comprehension of clinical trial details. The key factors contributing to participants' reluctance to engage in clinical trials encompass aspects of trial design, the operational procedures, insufficient understanding of clinical trial particulars, concerns about potential harm to their bodies and opposition from family members. Importantly, these areas of participants' hesitation and unwillingness to partake in clinical trials mirror the factors participants' dissatisfaction contributing to. Conclusion: We found four factors significantly influencing participants' willingness to engage and their overall satisfaction: the participant's profile, trial design, trial institution setup, and the qualifications of the researchers. Derived from these critical factors, this paper presents a series of constructive measures. Keywords: clinical trial, traditional Chinese medicine, compliance, satisfaction, participants
Xiao et al. (Sat,) studied this question.