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

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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.

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Acknowledgements

The authors would like to thank all clinical trial personnel who participated in the study, in particular, the following groups who provided access to their network: Health Research Board (HRB) Clinical Research Coordination Ireland (CRCI), HRB Irish Critical Care Clinical Trials Network, HRB Primary Care Clinical Trials Network Ireland, Qualitative Research in Trials Centre (QUESTS), Cancer Trials Ireland, HRB Stroke Clinical Trials Network Ireland, The Pharmaceutical Society of Ireland, Irish Research Nurses Network (IRNN), HRB Trials Methodology Research Network (TMRN), HRB Clinical Research Facility Cork, Tallaght University Hospital Dublin, St James’s Hospital Dublin, Royal College of Surgeons in Ireland (RCSI), HRB Clinical Research Facility Galway, University College Dublin Clinical Research Centre (UCD CRC), Cancer Clinical Trials Unit, Children’s Health Ireland Crumlin, Children’s Clinical Research Unit, National Children’s Research Centre, Centre for Advanced Medical Imaging (CAMI), and Irish Centre for Foetal and Neonatal Translational Research (INFANT).

Funding

This research was funded by the Health Research Board, Ireland.

Author information

Authors and Affiliations

  1. Health Research Board (HRB) Clinical Research Facility, University College Cork (UCC), 2nd Floor, Mercy University Hospital, Grenville Place, Cork, Republic of Ireland

    David O. Riordan & Joe Eustace

  2. Pharmaceutical Care Research Group, School of Pharmacy, UCC, Cork, Ireland

    Mary Kinane, Kieran A. Walsh & Margaret Bermingham

  3. HRB Clinical Research Facility and School of Public Health, UCC, Cork, Ireland

    Frances Shiely

Authors
  1. David O. Riordan
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  4. Frances Shiely
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  5. Joe Eustace
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  6. Margaret Bermingham
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by David O Riordan, Mary Kinane, Kieran A. Walsh, Frances Shiely, Joe Eustace and Margaret Bermingham. The first draft of the manuscript was written by David O Riordan, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to David O. Riordan.

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Ethical approval was required for this study as it involved human subjects.

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Informed consent was obtained from all individual participants included in the study.

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Riordan, D.O., Kinane, M., Walsh, K.A. et al. Stakeholders’ knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study. Eur J Clin Pharmacol 76, 1363–1372 (2020). https://doi.org/10.1007/s00228-020-02921-0

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