An Innovative Approach for the Development of an Early Phase Research Unit

Abstract

<strong>Background:</strong> Moving cancer outcomes forward is interdependent on increased participation in clinical trials. There is an increasing need in ambulatory oncology to develop formal structures which enable participation in complex research studies. <strong>Purpose:</strong> There was a lack of standardization in operationalizing care delivery for patients participating in complex trials in our Cancer Center, therefore a formal structure was needed. This project describes the framework for development, implementation, and sustainment of our early-phase research infusion unit (EPRU). Approach: Dedicated space, as well as a core team of nurses in the infusion area was identified. Workflow processes and standard operating procedures were initiated. Standard educational requirements and research-focused competency facilitated training compliance. Electronic data reports showed volume trends and along with an acuity tool supported staffing guidelines. <strong>Outcomes:</strong> Standardization of processes fostered adherence to research protocol requirements while accommodating increased complex research protocols and volume of patients. <strong>Conclusions:</strong> Nurses’ professional development is paramount to safe quality care of patients participating in clinical trials. Using an acuity tool to appropriately allocate resources, allows for accommodating increased complexity and volume. Systematizing processes fosters adherence to protocol requirements.