Healthy subjects volunteering for Phase I studies: Influence of curiosity, exploratory tendencies and perceived self-efficacy

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

Authors

Almeida, L (Author) Other; Kashdan, TB (Author) Other; 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: 109-118

ISSN: 0946-1965

Publisher: Dustri-Verlag Dr. Karl Feistle

Indexing

ISI Web of Knowledge - 9 Citations

Scopus - 11 Citations

Other information

Authenticus ID: P-004-15E

DOI: 10.5414/cpp46109

Abstract (EN): Objective: To test the hypothesis that trait-curiosity and perceived self-efficacy influence the willingness of healthy subjects to Volunteer for participation in Phase I studies. Materials and methods: A group of healthy subjects who had never participated in clinical studies ("index group") were invited to participate in a Phase I Study. They were assessed with regard to trait curiosity (Curiosity and Exploration Inventory; CEI-T) and perceived self-efficacy (Self-Efficacy Scale; SES) and Subjects who accepted the invitation to participate were compared with those who refused and with a group of healthy subjects who had previously participated in clinical Studies ("validation group"). Results: A significant positive correlation was found between the willingness to participate and the CEI-T total score (R = 0.28; p < 0.01), exploratory tendencies (R = 0.34; p < 0.001), SES total score (R = 0.30, p < 0.01), initiative and persistence (R = 0.29, p < 0.01), planning/goal setting (R 0.19, p < 0.05) and social self-efficacy (R 0.29; p < 0.01). The "Index group" subjects who accepted the invitation to participate showed significantly greater CEI-T exploratory tendencies (Z = -3.334, p = 0.001, Mann-Whitney test) and total scores (Z = -2.703, p < 0.01) and greater SES total score (Z -3.131, p < 0.01), initiative and persistence (Z = -3.065, p < 0.01), planning/goal setting (Z = -2.173, p < 0.05) and social self-efficacy (Z=-2.954, p < 0.01) than subjects who refused. No differences were found between the subjects in the "index group" who accepted the invitation and subjects in the "validation group". Using a logistic regression model, both CEI-T exploratory tendencies and SES initiative/persistence were significant predictors of participation. Conclusion: Subjects higher in curiosity/exploration and in perceived initiative/persistence are more willing to volunteer for Phase I studies. The impact of these self-selection biases on Phase I study results is unknown but deserves further evaluation.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 10