International journal of clinical pharmacology and therapeutics · 2008
Personality characteristics of volunteers in Phase 1 studies and likelihood of reporting adverse events.
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Almeida L, Falcão A, Vaz-da-Silva M, Coelho R, Albino-Teixeira A, Soares-da-Silva P
Аннотация
OBJECTIVE: To evaluate the personality characteristics of a group of participants in Phase 1 studies and to study the relation between the personality traits and the adverse events during participation.
METHODS: Study population consisted of 139 healthy volunteers to Phase 1 studies. Personality was assessed through the Revised NEO Personality Inventory (NEO-PI-R) and adverse events were monitored during participation.
RESULTS: Participants showed lower levels of Neuroticism (p < 0.001), and higher levels of Extraversion (p < 0.001) and Openness to Experience (p < 0.001) than the norm. In the Neuroticism domain, participants were lower in anxiety (p < 0.001), angry-hostility (p < 0.001), depression (p < 0.001), self-consciousness (p < 0.001) and vulnerability (p < 0.001), and higher in impulsiveness (p < 0.001). All facets of the Extraversion domain and all facets but "openness to esthetics" of the Openness to Experience domain were higher (p < 0.001) in the participants in relation to the norm. Participants were significantly lower (p < 0.05) on the overall Agreeableness domain, however, they were remarkably higher in altruism (p < 0.001) and trust (p = 0.001). Participants did not differ from the norm in the overall Conscientiousness domain, but they scored higher in competence (p < 0.001), achievement striving (p = 0.001) and self-discipline (p < 0.001). Females showed to report significantly more adverse events than males, and extraverted subjects showed to report less adverse events than introverted subjects.
CONCLUSION: Participants who volunteer for Phase 1 studies, differ from the general population in their personality characteristics. Some personality characteristics may have an effect on the probability of reporting adverse events during participation. Therefore, defining a personality of a volunteer may assume significant importance in Phase 1 studies.
METHODS: Study population consisted of 139 healthy volunteers to Phase 1 studies. Personality was assessed through the Revised NEO Personality Inventory (NEO-PI-R) and adverse events were monitored during participation.
RESULTS: Participants showed lower levels of Neuroticism (p < 0.001), and higher levels of Extraversion (p < 0.001) and Openness to Experience (p < 0.001) than the norm. In the Neuroticism domain, participants were lower in anxiety (p < 0.001), angry-hostility (p < 0.001), depression (p < 0.001), self-consciousness (p < 0.001) and vulnerability (p < 0.001), and higher in impulsiveness (p < 0.001). All facets of the Extraversion domain and all facets but "openness to esthetics" of the Openness to Experience domain were higher (p < 0.001) in the participants in relation to the norm. Participants were significantly lower (p < 0.05) on the overall Agreeableness domain, however, they were remarkably higher in altruism (p < 0.001) and trust (p = 0.001). Participants did not differ from the norm in the overall Conscientiousness domain, but they scored higher in competence (p < 0.001), achievement striving (p = 0.001) and self-discipline (p < 0.001). Females showed to report significantly more adverse events than males, and extraverted subjects showed to report less adverse events than introverted subjects.
CONCLUSION: Participants who volunteer for Phase 1 studies, differ from the general population in their personality characteristics. Some personality characteristics may have an effect on the probability of reporting adverse events during participation. Therefore, defining a personality of a volunteer may assume significant importance in Phase 1 studies.