Personality characteristics of volunteers in Phase 1 studies and likelihood of reporting adverse events

• Type: Article in International Scientific Journal
• Date: 2008

Authors

Almeida, L (Author) Other; Falcao, A (Author) Other; Vaz Da Silva, M (Author) FMUP; Coelho, R (Author) Other; Albino Teixeira, A (Author) FMUP; soares-da-silva, p (Author) FMUP

Journal

Title: International Journal of Clinical Pharmacology and Therapeutics

Vol. 46

Pages: 340-348

ISSN: 0946-1965

Publisher: Dustri-Verlag Dr. Karl Feistle

Indexing

ISI Web of Knowledge - 14 Citations

Scopus - 16 Citations

Other information

Authenticus ID: P-003-Y3N

DOI: 10.5414/cpp46340

Abstract (EN): 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.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 9