Who volunteers for phase I clinical trials? Influences of anxiety, social anxiety and depressive symptoms on self-selection and the reporting of adverse events

• Published in: European journal of clinical pharmacology Vol. 64; no. 6; pp. 575 - 582
• Main Authors: Almeida, Luis, Kashdan, Todd B., Nunes, Teresa, Coelho, Rui, Albino-Teixeira, António, Soares-da-Silva, Patrício
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.06.2008; Springer; Springer Nature B.V
• Subjects: Adolescent; Adult; Adverse events; Anxiety; Anxiety - psychology; Avoidance behavior; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Clinical Trial; Clinical trial. Drug monitoring; Clinical trials; Clinical Trials, Phase I as Topic - psychology; Depression - psychology; Female; General pharmacology; Human Experimentation; Human subjects; Humans; Male; Medical sciences; Mental depression; Middle Aged; Patient Selection; Personality; Personality traits; Pharmacology; Pharmacology. Drug treatments; Pharmacology/Toxicology; Social anxiety; Social behavior; Volunteers; Depressive symptoms; Anxiety; Healthy volunteers; Adverse events; Phase I studies; Social anxiety; Mood disorder; Human; Affect affectivity; Healthy subject; Social phobia; Selection; Volunteer; Anxiety disorder; Self-selection; Depression; Adverse events; Anxiety; Treatment; Secondary effect; Phase I trial
• ISSN: 0031-6970; 1432-1041
• DOI: 10.1007/s00228-008-0468-8

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 (“Naïve Subjects”) were invited to participate in a phase I study. All subjects were assessed for trait anxiety (State-Trait Anxiety Inventory, STAI-T), social anxiety (Social Avoidance and Distress, SAD, and Fear of Negative Evaluation, FNE) and depressive symptomatology (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. Naïve 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 adverse events. Conclusion Participants in phase I studies are a self-selected sample defined by low trait-anxiety and social avoidance behaviors. This self-selection bias may affect the study results because less anxious subjects tend to report fewer adverse events. The characterization of a participant’s personality traits may be important in phase I studies.