Case Study of Transitioning a Clinical Trial from a Clinical Research Facility (CRF) to the Neurology Clinical Service Outpatient Department

ABSTRACT

Objectives: It was recognised that a later phase extension study was less intense and a potential to transition to the clinical service with support from a coordinator, Epilepsy CNS (Clinical Nurse Specialist) and Neurology fellow. This case study will explore the planning, implementation methods, challenges and successes from the medical, nursing and family perspectives. Method(s) Initial strategic planning will be demonstrated and include a pathway taken to implement the transition. The requirements of the study were assessed, and a model was established of how the study will run in the clinical service. The CNS role was expanded to include research. Teaching and support were provided by the CRF team outlining individual roles and responsibilities. In order to understand the family, medical and nursing experience of research transition, a questionnaire has been completed at the end of study. Result(s) Challenges included new team to research, CNS time, medication accountability management, visit coordination, Covid-19 pandemic impacts on patient visits, and medical responsibilities combining clinical and research care. Collaborative solutions were found overcome these challenges. Positive outcomes: Epilepsy CNS available to families, new CNS skills, and stronger links established between research and clinical. Questionnaires have been analysed to gather data on patient experience, and common themes have been highlighted for considerations to take forward to future trial transitions. Conclusion(s) Overall, it has been a smooth successful transition. This has shifted the culture mindset that research and clinical care running separately. The drug is now approved for use as recommendation on NICE guidelines. The case study is a prime example of research and the clinical service working in unison. Portraying the research journey from early phase to NHS usage.