Help Patients Understand Biomarker Test Results and Clinical Trials Options

December 16, 2021 by Vicki Doctor BSN, BSW, RN, OCN®

Many of today’s new drug approvals and standard-of-care treatments have a companion diagnostic test that identifies biomarkers in a patient’s tumor tissue or blood to determine whether they are an appropriate candidate for the therapy. When those results show that they’re not a good match for the U.S. Food and Drug Administration (FDA)-approved treatment, the findings may identify a biomarker-directed clinical trial as an alternative option. Here’s how oncology nurses can help patients understand which clinical trials listed on their test results might be an option for them.

The Basics of Biomarkers and Test Results

Testing can identify inherited DNA changes (germline) that increase a person’s cancer risk, but it can also uncover acquired changes in a tumor (somatic) and help suggest ( therapies that could target the driver variant that is leading to cancer growth. Biomarker test results contain the following details that you can help your patients understand:

Keep in mind that clinical trials identified on a biomarker test result are the ones listed on the website at the time of test result and might not still be enrolling patients later. If your setting doesn’t have a clinical trial team, visit to confirm whether a trial is currently still enrolling ( You may also call the site investigator to be certain that trial is still open.

Additionally, many biomarker-driven clinical trials are designed differently than traditional trials. Basket trials study ( patients with different cancer diagnoses but the same biomarker who receive one targeted drug, whereas umbrella trials offer multiple targeted drug options for a single type of cancer. By design, both types of trials are available across multiple institutions in a variety of geographic locations, increasing available options for some patients.

Your role as an oncology nurse often requires you to be a patient advocate for biomarker-driven clinical trials. Helping patients to understand their biomarker test results can empower ( them to feel certain that they have explored every treatment possibility available.

Copyright © 2021 by the Oncology Nursing Society. User has permission to print one copy for personal or unit-based educational use. Contact for quantity reprints.