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Sensation seeking amongst healthy volunteers participating in phase I clinical trials.

机译:在参加I期临床试验的健康志愿者中寻求感觉。

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摘要

1. Phase I clinical trials are usually carried out in healthy volunteers. In addition to economic gain, factors that may influence willingness to participate include scientific interest, curiosity and choice for risky activities. 2. We assessed the relationship between personality variables and volunteering for clinical pharmacology research. Two personality questionnaires, the Sensation Seeking Scale (SSS, form V) and the Eysenck Personality Questionnaire (EPQ), were administered to 48 male healthy university students who volunteered to participate in a phase I clinical trial and to 43 male university students who were not willing to participate in phase I clinical trials. General norm data were also used for the comparison of results. 3. When healthy volunteers were compared with unwilling subjects, significant differences were found in thrill-and-adventure seeking (7.9 vs 6.7, P = 0.0034), experience seeking (6.4 vs 5.2, P = 0.0012), disinhibition (6.2 vs 4.3, P < 0.0001), boredom susceptibility (3.9 vs 2.8, P = 0.0073), total sensation seeking trait (24.3 vs 19.0, P < 0.0001), extraversion (15.1 vs 13.3, P = 0.0490), and psychoticism (4.4 vs 3.5, P = 0.0086). When healthy volunteers were compared with general norm data similar statistically significant differences were found in all these scales, except for boredom susceptibility and psychoticism. 4. The personality profile of healthy volunteers was characterized by a higher sensation seeking trait and extraversion as compared with individuals who were not willing to participate in phase I clinical trials and general norm data.
机译:1. I期临床试验通常在健康志愿者中进行。除了经济利益外,可能影响参与意愿的因素还包括科学兴趣,好奇心和冒险活动的选择。 2.我们评估了人格变量和自愿进行临床药理学研究之间的关系。向自愿参加I期临床试验的48名男性健康大学生和43名自愿参加第一阶段临床试验的男性健康大学生发放了两份个性问卷,即“感觉寻求量表”(SSS,表格V)和“艾森克人格问卷”(EPQ)。愿意参加I期临床试验。一般规范数据也用于结果比较。 3.将健康志愿者与不愿接受治疗的受试者进行比较时,发现在寻求刺激和冒险方面(7.9 vs 6.7,P = 0.0034),寻求经验(6.4 vs 5.2,P = 0.0012),抑制力(6.2 vs 4.3)有显着差异。 P <0.0001),无聊感(3.9 vs 2.8,P = 0.0073),总感觉寻求特质(24.3 vs 19.0,P <0.0001),外向性(15.1 vs 13.3,P = 0.0490)和精神病(4.4 vs 3.5,P = 0.0086)。当将健康志愿者与一般规范数据进行比较时,除了无聊感和精神病外,在所有这些量表中都发现了类似的统计学显着差异。 4.与不愿参加I期临床试验和一般规范数据的个体相比,健康志愿者的性格特征是其寻求特质和性格外向的感觉更高。

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