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

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

Authors

Almeida, L (Author) Other; Kashdan, TB (Author) Other; Nunes, T (Author) Other; Coelho, R (Author) Other; Albino Teixeira, A (Author) FMUP; soares-da-silva, p (Author) FMUP

Journal

Title: European Journal of Clinical Pharmacology

Vol. 64

Pages: 575-582

ISSN: 0031-6970

Publisher: Springer Nature

Indexing

ISI Web of Knowledge - 30 Citations

Scopus - 32 Citations

Other information

Authenticus ID: P-003-YRG

DOI: 10.1007/s00228-008-0468-8

Abstract (EN): 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 ("Naive 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. Naive 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.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 8