Content area
Full Text
Eur J Clin Pharmacol (2008) 64:575582 DOI 10.1007/s00228-008-0468-8
CLINICAL TRIAL
Who volunteers for phase I clinical trials? Influences of anxiety, social anxiety and depressive symptoms on self-selection and the reporting of adverse events
Luis Almeida & Todd B. Kashdan & Teresa Nunes &
Rui Coelho & Antnio Albino-Teixeira &
Patrcio Soares-da-Silva
Received: 6 November 2007 / Accepted: 31 January 2008 / Published online: 5 March 2008 # Springer-Verlag 2008
Abstract Objective To investigate the influence of anxiety, social anxiety and depressive symptoms on the willingness of healthy subjects to volunteer for phase I studies and to report adverse events.Materials and methods A group of healthy subjects who had never participated in a clinical trial (Nave Subjects)were invited to participate in a phase I study. All subjects were assessed for trait anxiety (State-Trait Anxiety Inventory, STAIT), social anxiety (Social Avoidance and Distress, SAD, and Fear of Negative Evaluation, FNE) and depressive symptom-
L. Almeida (*) : T. Nunes : P. Soares-da-Silva Department of Research and Development, BIAL (Portela & Co, SA),A Av. da Siderurgia Nacional, 4745457 S Mamede do Coronado, Portugal e-mail: [email protected]
L. Almeida : A. Albino-Teixeira : P. Soares-da-Silva Institute of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto,Alameda Professor Hernni Monteiro,Porto, Portugal
T. B. KashdanDepartment of Psychology, George Mason University, Fairfax, VA, USA
R. CoelhoService of Psychiatry and Mental Health, Faculty of Medicine, University of Porto,Rua do Campo Alegre,Porto, Portugal
A. Albino-Teixeira Institute for Molecular and Cell Biology (IBMC), University of Porto, Alameda Professor Hernni Monteiro,Porto, Portugal
atology (Beck Depression Inventory, BDI-II). Subjects who accepted the invitation to participate were compared with those who refused. The personality traits of a group of Actual Participants were examined, and the relation of these traits to adverse events reported during participation was evaluated. Results A significant inverse correlation was found between the STAI-T (R=0.203, p<0.05) and SAD (R=0.204, p<0.05) scores and the willingness to participate. Nave Subjects who refused the invitation to participate showed higher scores on STAI-T (Z=2.600, p<0.01) and SAD (Z=2.524, p<0.05) inventories. Logistic regression using BDI-II, STAI-T, SAD and FNE as covariates also showed that the only unique predictors of participation were the STAI-T ( p<0.05) and SAD ( p<0.01) scores. Significant positive correlations were found between trait anxiety and reporting of...