治験参加者を対象とした治験に関する意識変化を 定量的に解析した研究

小嶋 亜純, 山崎 晶司, 吉尾 卓

doi:10.3999/jscpt.48.41

Background: Many surveys on perception changes in clinical trial participants have been conducted. However, these surveys have provided only qualitative evaluations of the impressions in participating in clinical trials. The degree of perception changes in participants during clinical trials and the factors that contribute to perception changes remain unclear.Objective: Understanding the perceptions of participants is extremely important to promote clinical trials. The aims of this study were to clarify quantitatively the degree of perception changes in participants during clinical trials and to identify the factors contributing to the changes.Methods: We surveyed perception changes in the same participants before and after clinical trials. The degree of anxiety towards clinical trials was determined using the Visual Analog Scale (VAS). The factors contributing to perception changes in participants were also analyzed.Results: Participants expected positive therapeutic effects, but also had a vague sense of anxiety prior to clinical trials. The mean VAS score for anxiety was 46.7 mm before clinical trials and decreased significantly to 38.0 mm after clinical trial (P＝0.002). Factors that contributed to perception changes by participants included the effectiveness of the investigational drug for individual trial participant and constraint of clinical trial schedule. In addition, the management of clinical research coordinators (CRC) was highly evaluated by participants.Conclusion: These results suggested that CRC should contribute to the promotion of clinical trials by supporting participants who feel anxious and proposing treatment methods that reduce burden on participants to clinical trial sponsors.

<b>治験参加者を対象とした治験に関する意識変化を </b><b>定量的に解析した研究 </b>

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