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

September 2011 Vol 2, No 5
Eileen Dehm, RN, BSN

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.

Related Articles
Improving Diversity in Cancer Trials: The Role of the Nurse Navigator
Margo Michaels, MPH, Leah Szumita, MS, RN, ACNS-BC
|
Online First
Addressing barriers to clinical trial participation is critical to accelerate progress toward more effective (and less toxic) cancer treatments and provide patients with access to novel treatment approaches. Receiving treatment in a clinical trial is considered by many to be high-quality cancer care; the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology state that “the best management for any cancer patient is in a clinical trial.
“What’s in It for Me?” Helping Patients Understand Oncology Clinical Trials
July 2023 Vol 14, No 7
Cancer clinical trials offer patients an opportunity to be treated with the most cutting-edge and promising cancer therapies available, but the majority of patients who are offered these trials still are not signing up for them. This might frustrate those in the know, but many patients simply do not understand what these trials entail.
Myths and Truths About Clinical Trials
June 2023 Vol 14, No 6
Executive Summary: Clinical trials for cancer treatments offer patients invaluable access to emerging therapies but are not always well understood by patients or even the medical community. Closing the gap between high patient interest levels and low patient enrollment will help thousands of patients benefit from cutting-edge therapies while accelerating advances for future patients.
Last modified: August 10, 2023

Subscribe Today!

To sign up for our print publication or e-newsletter, please enter your contact information below.

I'd like to receive:

  • First Name *
    Last Name *
     
     
    Profession or Role
    Primary Specialty or Disease State
    Country