From Clinical Trials to Commercial Use: A Nurse Navigation Strategy to Promote Early Intervention and Consistent Management of Adverse Reactions in the Outpatient Setting

Background: The clinical foundation of most academic medical centers is their clinical trials. These highly regulated programs offer controlled access to investigational drugs to patients who have failed standard-of-care therapy. The implementation and daily management of patients on clinical trials is led by a research nurse. After a drug becomes commercially available, research nurse involvement is no longer available. The expertise of the research nurse was valuable to both patients and infusion nurses. Confusion may occur for nurses who previously infused a drug on a clinical trial and now request information about the “new” drug they are infusing “off-protocol.” Although the US Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategies (REMS) are valuable tools and help to ensure patient safety, these tools often stop short of being practical in day-to-day clinical practice.

Purpose: The field of oncology has had several new agents approved recently, including ipilimumab (Yervoy, Bristol-Myers Squibb), denosumab (Xgeva, Amgen), and sipuleucel-T (Provenge, Dendreon). The oncology nurse navigator (ONN) can serve as a liaison between the clinical trials operation and the development of protocols and education models for a commercial drug. Using the resources available through the drug manufacturer and a close review of the clinical trial protocols, the ONN can develop personalized education programs.

Methods: We used an ONN to facilitate enrollment of patients and caregivers for support and resources available from Bristol-Myers Squibb for ipilimumab, FDA-approved for stage IV metastatic melanoma. Ipilimumab is associated with immune-related response patterns and immune-mediated adverse reactions, both of which require a new approach for optimal management.

Results: By engaging patients to participate in personalized support programs, patients have demonstrated confidence in recognizing symptoms early and effectively communicating them to the clinical management team, allowing for timely interventions and often preventing complications and costly hospitalizations.

Conclusion: ONNs can take the lead in assuring that all patients and nurses are prepared adequately for treatment with a newly approved drug after the restrictions and support disappear. This need for enhanced patient management presents an interesting and exciting role for ONNs.