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

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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 (“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.

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Acknowledgements

We thank the healthy subjects and the clinical staff of the clinical pharmacology unit of BIAL – Portela & Co, SA (especially Prof. Manuel Vaz-da-Silva, 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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Authors and Affiliations

  1. Department of Research and Development, BIAL (Portela & Co, SA), A Av. da Siderurgia Nacional, 4745–457, S Mamede do Coronado, Portugal

    Luis Almeida, Teresa Nunes & Patrício Soares-da-Silva

  2. Institute of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Alameda Professor Hernâni Monteiro, Porto, Portugal

    Luis Almeida, António Albino-Teixeira & Patrício Soares-da-Silva

  3. Department of Psychology, George Mason University, Fairfax, VA, USA

    Todd B. Kashdan

  4. Service of Psychiatry and Mental Health, Faculty of Medicine, University of Porto, Rua do Campo Alegre, Porto, Portugal

    Rui Coelho

  5. Institute for Molecular and Cell Biology (IBMC), University of Porto, Alameda Professor Hernâni Monteiro, Porto, Portugal

    António Albino-Teixeira

Authors
  1. Luis Almeida
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  2. Todd B. Kashdan
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  3. Teresa Nunes
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  4. Rui Coelho
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  5. António Albino-Teixeira
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  6. Patrício Soares-da-Silva
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Correspondence to Luis Almeida.

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Almeida, L., Kashdan, T.B., Nunes, T. et al. Who volunteers for phase I clinical trials? Influences of anxiety, social anxiety and depressive symptoms on self-selection and the reporting of adverse events. Eur J Clin Pharmacol 64, 575–582 (2008). https://doi.org/10.1007/s00228-008-0468-8

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  • DOI: https://doi.org/10.1007/s00228-008-0468-8

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