Authors: Luis Almeida Todd B Kashdan Teresa Nunes Rui Coelho António AlbinoTeixeira Patrício SoaresdaSilva
Publish Date: 2008/03/05
Volume: 64, Issue: 6, Pages: 575-582
Abstract
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 StateTrait Anxiety Inventory STAIT social anxiety Social Avoidance and Distress SAD and Fear of Negative Evaluation FNE and depressive symptomatology Beck Depression Inventory BDIII 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 evaluatedA significant inverse correlation was found between the STAIT R = −0203 p 005 and SAD R = −0204 p 005 scores and the willingness to participate Naïve Subjects who refused the invitation to participate showed higher scores on STAIT Z = −2600 p 001 and SAD Z =−2524 p 005 inventories Logistic regression using BDIII STAIT SAD and FNE as covariates also showed that the only unique predictors of participation were the STAIT p 005 and SAD p 001 scores Significant positive correlations were found between trait anxiety and reporting of adverse eventsParticipants in phase I studies are a selfselected sample defined by low traitanxiety and social avoidance behaviors This selfselection 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 studiesWe thank the healthy subjects and the clinical staff of the clinical pharmacology unit of BIAL – Portela Co SA especially Prof Manuel VazdaSilva and Benedita Azevedo BSc Psychol for their cooperation We also thank Prof Amílcar Falcão and Dr Grazina Binkauskiene for their assistance with the statistical analysis
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