From Enrollment to Informed Consent, Nurses Are Vital in the Clinical Trial Process

Oncology nurses are valuable players in enrolling patients in clinical trials, and then guiding them through the process — especially when it comes to complicated informed consent documents – explained Katie Goodman, RN, BSN, CCRP, the director of clinical research at Florida Cancer Specialists.

“The oncology nurse plays a critical role in the management of patients on a clinical trial,” Goodman said in a recent interview with Oncology Nursing News.

Oncology Nursing News: What role do oncology nurses play in clinical trial recruitment and support?

Goodman: We feel that physicians will largely identify patients who are eligible for clinical trials, but the nurse will oftentimes facilitate the work that has to happen to get a patient on the trial. We follow the protocol to get baseline testing performed according to the protocol schedule, and then we really work to get the patient on the study.

We educate the patients on the things they need to know. We will often go through the consent form page by page, which can sometimes be 10 or 15 pages long in oncology. The oncology nurse will spend a lot of time with the patients, making sure they truly understand that consent form and what's involved in the clinical trial.

Once the patient enrolls, nurses will then also meet with them at nearly every visit to do things like review all of their current medications that they might be on, any side effects that they might be experiencing, and again helping the patient to manage any side effects that they have.

What kind of issues might occur regarding the informed consent process?

The informed consent process is a lengthy one. It usually requires multiple meetings with patients. The physician may often introduce the trial, but an oncology nurse is often the one who is sitting down and going through that consent on a more detailed level. For example, we need to make sure patients understand the numbers of visits that may be involved, so they understand that commitment. What kind of lab work will they be agreeing to? Is there additional lab work? For example, many studies will collect additional biomarkers or even biopsies or tissue samples that they want to perhaps use in later research and that patient has to understand that during the consent process so that they can make a decision on whether or not they want to participate.

The consent process also involves the risks and benefits of participating in that trial. Patients need to understand what the potential risks are, and what are the potential benefits. What happens if they don't go on this trial? That's all a part of that consent process to make sure that they understand what they are committing to.

What important information would you like to give oncology nurses regarding clinical trials?

I hope that oncology nurses learn that they are a valued piece of that puzzle in getting patients on trials. I hope they learn to know how to better explain what a clinical trial means to a patient, where they can get their answers if they have questions, and how to find a clinical trial. Any oncology nurse or a patient can go to clinicaltrials.gov and really search and help identify potential trials or a center that might be participating in multiple trials that could have something to offer.