Knocking Down Barriers: Education and Preparation of Nursing Staff for Complex Clinical Trials.

Clinical research has always been a part of transplantation; however, with breakthroughs in cellular immunotherapy (CI), such as CAR T-cell and T-cell receptor therapy, the number of clinical research trials in this area has rapidly increased. At our center, there are currently 38 open CI trials with 15 more opening in the next few months. These trials are multifaceted and complex requiring intensive coordination, development of workflows, diligent nursing care, and additional education across departments and treatment settings. To safely and efficiently run a trial, a study start up process must be in place. Nursing leadership including managers, a CNS, and an education specialist, played an integral role in the interdisciplinary team collaboration required for conducting successful clinical trials. Nursing leadership began attending site initiation visits and implementation meetings to gain insight into each new clinical trial and develop patient and nursing workflows. Nursing leadership also assists the clinical trial coordinators (CTC) with the creation of a "quick reference" protocol summary education sheet that is used to assist with caring for the patient. A bi-weekly clinical trials operational meeting, attended by nursing leadership and CTCs, was initiated to discuss problems or issues with current trials. To address knowledge deficits related to CI and specific clinical trials, existing education materials were updated and additional education was created as needed. The unit-based orientation was also modified to include content on CI and clinical trials. Prior to opening, each new clinical trial now undergoes a standardized process to determine appropriate workflows, outline the patient journey, and identify education needs. Nursing is involved in every step of the process, which has positively impacted the safety and efficacy of the trials. Although it is an ever-evolving work in progress, the clinical trial process at our institution has allowed for the successful implementation of numerous CI clinical trials. Our processes have been replicated by the clinical trial industry as a model for other organizations. Nursing participation and leadership is essential for successful clinical trial implementation and safe patient care. [ABSTRACT FROM AUTHOR]