Translational Research Unit: Development of Nursing Standards and Practice Within a Specialized Unit for Participants in Early Phase Clinical Trials

Background: A growing need exists to ensure safe and skilled oncology nursing care for an increasing number of patients enrolled in phases 1 and 1/2 clinical trials and to provide detailed adherence to protocol administration. This can be best accomplished in a dedicated area for patients in early phase clinical trials.

Objectives: Nursing standards and practice within a newly established translational research unit at an academic medical center were developed.

Methods: A portion of an existing outpatient infusion room composed of 13 beds and a sub-waiting room with 2 chairs was designated for placement of patients enrolled in early phase clinical trials. The functional and safety requirements needed to successfully care for these patients while meeting the demands of the trial protocol drove the creation of this dedicated unit.

Findings: Development of dedicated space provided opportunities to define the role of the nurse and hardwire patient and staff safety practices that assisted in reducing study deviations.