Abstract

Background: Clinical research has expanded in many fields with oncology growing vastly in the last 5 years. Specialised nursing and healthcare support is imperative for the smooth operation of the research aspect of a unit, aiming to deliver better care to patients (pts) participating in clinical trials. Methods: Retrospective review of the structure of the Research Clinics between November 2016 and April 2018 in Royal Marsden Hospital in the Gastrointestinal and Lymphoma Unit. Results: The Lead Research Nurse (LRN) structured the team by identifying the complexities involved in running a dedicated Research clinic, developing new roles and assigning the appropriate research team members to support the Clinical Research Fellows. The LRN introduced the role of Assistant Practitioners (APs)who support the running of the clinic by taking vital signs, performing ECG’s and other trial related procedures, such as entering source data into the Electronic Case Report Forms for the sponsor of each clinical study. This has enabled the Clinical Research Nurses (CRN) to spend more time with pts, assessing them for new or existing adverse events, recording concomitant medications, checking blood results, and completing Holistic Needs Assessments at required points throughout treatment. The LRN expanded the role of the Biological Specimen Coordinator (BSC) enabling them to perform phlebotomy on Research pts and take consent for a Translational Research protocol, making their role more hands on and improving retention in this job group. Conclusions: The LRN has a crucial role leading, supervising and developing a split site team consisting of ten CRNs: 5 senior CRNs, 5 junior CRNs, a Translational Research Manager, 5 BSCs and 2 APs. We have achieved a holistic approach for the trial pts whose needs might differ from the usual treatment setting due to the experimental nature of these trials. Our well-structured process has helped pts build better rapport with the team, understanding the importance of all members and various aspects in clinical research. Further training is warranted with Research nurses undertaking advanced practice education, with the view for this model to be adopted in other specialties and institutions. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

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