Nurses, APPs Lead as Sub-Investigators in Oncology Clinical Trials

Oncology nurses and advanced practice providers (APPs) can take a leadership role in clinical research, according to a nurse practitioner working in multiple myeloma research.

In an interview with Oncology Nursing News, Kiah Purcell, MSN, AGPCNP-BC, emphasized that nurses perform much of the clinical work with patients during clinical trials, including informing them on consent and managing and screening patients for eligibility and exclusion criteria.

According to Purcell, the program at Mount Sinai, where she practices, is highly “nurse led,” with nurses and APPs being sub-investigators and taking the lead in pre-screening and testing, triages, and patient education.

Nurses and APPs see patients who are receiving trial medication and coordinate with research companies about questions patients may have or dosing issues.

Purcell added that nurses and APPs are responsible for keeping track of and categorizing adverse effects, which later become the data available in package inserts.

Transcript

We’re very involved in clinical trials. [Mount Sinai] has a very big [multiple myeloma] clinical trial department, which I’ve been working in. APPs and the nurses do a lot.

You are a sub-investigator on the study, so that means that you are on the delegation of authority, and you can do a lot for the clinical trial. The doctor consents them, but I will educate them on the entire protocol.

I will educate them, go through the entire consent, make sure they are eligible. I look at inclusion [and] exclusion criteria. We screen them, we pre-screen them, we make sure all the appropriate tests are done that are needed for trial.

APPs and nurses are the first people that the patient will go to. So we usually do triage, do the calls. I see the patients that are then enrolled on clinical trials. I see them on their days that they’re receiving their research medication.

I characterize their toxicity. All the toxicities while on a medication need to be characterized so they can be reported. When you look at a medication and you look at the insert that says “50% of patients had this,” we’re actually taking that data from the patient and putting it into a database so we have those numbers. So we do that.

Sometimes we see the patients independently, actually quite a bit. Some days physicians will see the patients with us. We communicate with the research companies about patients being housed, dose questions. We are very involved.

We have to read the research protocols and [know] exactly what’s allowed and what’s not allowed. The program at Mount Sinai is really nurse led. We have 10 physicians in our group that are all the primary investigators. They all have different studies that they are responsible for.

They’re the physician responsible for the study, but really the nursing team is doing most of the clinical work with the patients and really following that patient very closely to make sure it’s still safe and we’re still okay with the study and that there’s nothing popping up that needs to be reported.

This transcript has been edited for clarity and conciseness.