Nurs-15. The Role of the Advanced Practice Provider and Nurses in Clinical Trials

Abstract BACKGROUND For many years clinical trials fell under the umbrella of medicine without much acknowledgement to the role of the nurse, both as advanced practice provider (APP) and staff nurse. Oncology continues to rank as one of the highest subspecialties when it comes to availability and participation in clinical trials. There remain multiple barriers to involvement including availability, lack of education, and medical mistrust. The specialized role and skill set of the APP and RN as part of the clinical trial team is important in overcoming these barriers. METHODS We distributed a survey to members of the Advanced Practice Provider and Nurse Investigator Committee (APPNIC), a group within the Pediatric Neuro-Oncology Consortium (PNOC), in order to identify themes, barriers to care, and opportunities for both the APP and RN within clinical trials. The use of a survey and interviews within our APPNIC cohort allowed us to collaborate on the nursing role, prioritize care in new and amended trials, and share unanticipated adverse effects and effective management. RESULTS APPs are actively involved with clinical trial enrollment, performance of diagnostic exams and procedures, education, and early recognition/management of adverse effects. There is also a growing theme of the APP as sub-investigator which provides value in facilitating consent, impacting accrual, determining eligibility, managing anticipated side effects. The role of the staff nurse in clinical trials is found to be vital in providing consistent communication/support, educating patients and families, and alleviating adherence and medical mistrust. CONCLUSION The APP and nurse have a specialized, relevant skill set, which when included as part of the multi-disciplinary team, has the ability to decrease barriers and increase overall delivery and safety of clinical trials. Our goal is to outline specific roles we feel should be standardized in the international arena for nursing involvement within clinical trials.