Clinical research nurse utilisation and role in the conduct of decentralised clinical trials: a literature review

Abstract

Background: The decentralised clinical trial (DCT) model has been popularised given its remote or virtual design, permitting expanded participant enrolment into community settings. Clinical research nurses (CRNs) are specially trained in the management of clinical trials; however, the utilisation of the research nurse role relating to decentralised trial conduct is not well-established. Aims: A literature review was conducted to describe the role of the research nurse in the conduct of DCTs and the current utilisation of this nurse specialty for decentralised trial management. Methods: Use of keywords ‘DCT’ or ‘virtual trial’ and ‘nursing’ were used to identify full-text, peer-reviewed literature in the English language and published within the last 10 years that described the clinical research nursing role. Results: Of the 102 pre-screened articles identified across five databases, 11 articles were eligible for full-text analysis. Thematic groupings of common discussion elements included Variance in Decentralised Clinical Trial Model Implementation, CRN Involvement in Decentralised Trial Conduct and Reporting and Shared Challenges of Decentralised Trial Implementation Affecting the CRN Role. Conclusions: Implications of this literature review include expanded trial sponsor awareness of the support requirements to facilitate research nurse utilisation and optimal decentralised trial conduct.