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. 2020 Oct;76(10):1363-1372.
doi: 10.1007/s00228-020-02921-0. Epub 2020 Jun 7.

Stakeholders' knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study

David O Riordan  1 , Mary Kinane  2 , Kieran A Walsh  2 , Frances Shiely  3 , Joe Eustace  4 , Margaret Bermingham  2
Affiliations

Stakeholders' knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study

David O Riordan et al. Eur J Clin Pharmacol. 2020 Oct.

Abstract

Purpose: The purpose of this study was to explore the knowledge, attitudes and practices of health professionals working in clinical trials, to pharmacovigilance and adverse drug reaction (ADR) reporting.

Methods: A mixed methods study comprising an online questionnaire disseminated from September to November 2018, three semi-structured interviews and four focus groups. The qualitative components were conducted with a random sample of questionnaire participants who had provided their contact details (n = 24). The qualitative interviews were conducted at a location convenient to the participant's place of work between October and December 2018.

Results: One hundred forty-eight participants completed the questionnaire. Study coordinators/project managers represented the largest group of participants ( 28.6%, n = 38). Poor knowledge or understanding of ADR reporting was the most frequently cited barrier to ADR reporting (75%, n = 93). The most common enabler to reporting was having a clear understanding of an ADR definition (85.7%, n = 108). Focus group and interview participants described having limited staff as a barrier to reporting an ADR. They welcomed the prospect of pharmacovigilance training and indicated that face-to-face training would be preferred to provision of online training.

Conclusion: This study highlights key factors that influence the reporting of ADRs in clinical trials. Although the findings are specifically related to the clinical trial environment in Ireland, they may provide a useful platform for optimising the future conduct of trials. This research suggests that ADR reporting may be improved through provision of enhanced pharmacovigilance training to clinical trial staff.

Keywords: Adverse drug reaction reporting; Clinical trial; Pharmacovigilance.

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References

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