Research Nurses: The Glue That Holds Everything Together

Nurse practitioner in hematologic malignancies and research associate at Johns Hopkins School of Medicine and The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland

After graduating from nursing school, I worked as a registered floor nurse for nine years before becoming a research nurse. Then, while I was working as a research nurse, I was also attending graduate school to become a nurse practitioner. Of these experiences, the steepest learning curve I encountered – by far – was in discovering the complexities of research nursing.

A research nurse has to be whatever the person in front of you needs the nurse to be. The position requires a very nimble mind – shifting from clinical care to compliance to documentation to study protocol – and jumping through all the necessary hoops and wrangling all of the involved parties… It’s simply mindboggling and, until you are neck-deep into it, you might never know it existed.

The role of the research nurse can be nebulous and, for the most part, the work these advanced practice practitioners (APPs) do is not tangible, or even visible, to other health-care providers. Many of our clinical colleagues may wonder what we do when we aren’t physically seeing patients. The short answer? A lot.

What Exactly Do We Do?

The scope of the research nurse is broad, and it varies from center to center. Research nurses are the glue that holds everything together. They are responsible for protocol compliance from A to Z. Depending on their institution and job responsibilities, some research nurses are also tasked with the data management portion of the research work – filling out case report forms and handling the regulatory work.

Overall, our job is to answer questions – from patients, principal investigators, and all parties involved in the clinical research enterprise.

Typically, it is the physician, not the research nurse, who identifies potential patients for trials. But, from the initial discussion with a patient about the possibility of enrolling in a trial to the point when a patient is receiving treatment under the study protocol, the research nurse is the patients’ primary point of contact.

Once a patient expresses interest in participating in a clinical trial, the research nurse walks him or her through the consent process – reviewing a 25-page (or more) document outlining every single aspect of the study. This is probably the most critical part of ensuring a patient is truly informed of a trial’s risks and benefits, and also the part least often captured when we track our time to trials!

Then, after the patient has consented to participate in the trial, the research nurse sets up all of the screening tests and confirms the patient’s eligibility with the principal investigator.
Our job isn’t done when the trial is underway. We continue to work closely with patients to ensure that the study protocol is being followed, that they are receiving the right dose of the drug, that all of the tests are being done per-protocol, that any dose reductions or dose modifications are recorded properly, and that they are receiving the appropriate supportive care for symptom management.

Out of Sight, Out of Mind?

The average physician or principal investigator understands the broad strokes of what a research nurse does, but probably does not fully comprehend the scope of his or her responsibilities. Although they may never completely understand the specifics of what the research nurse does, most of them trust us enough to keep their names off the front page of the local newspaper!

Again, many aspects of the job are not tangible, and that includes the communication between all the various health-care professionals who interact with our clinical trial patients.

This communication with other members of the health-care team sets hematology/oncology apart from many other disciplines. In fact, other disciplines typically do not have dedicated research nurses because the care is not complex enough to require them. But, with our oncology patients, the care is extremely complex and multidisciplinary. Without a nurse to coordinate and shepherd all of that through the clinical trials process – while also keeping the involved parties in the loop – patient safety (and study protocol) could never be maintained.

That collaboration is a hugely overlooked part of the clinical research puzzle: Everyone who comes into clinical contact with that clinical trial patient also needs to be cognizant of the research protocol to understand the implications and special considerations of the trial. This is especially important for providers who care for our patients, but may not be formal investigators on the clinical trial. Clinical care trumps the protocol every time, but we need to make sure the defined protocol is being followed.

Collaboration and education, therefore, is constant. Our goal, above everything, is to keep the patient safe, but clinicians also need to keep the limitations in mind.

Priming the Pump

With so many moving parts and the participation of so many people, there are plenty of opportunities for mistakes, setbacks, and missteps. The greatest challenge to making clinical trials run smoothly is getting patients enrolled – without them, there would be no trials.

There is no method for easily and accurately capturing the amount of (occasionally fruitless) work that goes into enrolling a patient into a clinical trial. Principal investigators tend to look at hard numbers (i.e., “How many patients have we put on this trial?”), but may forget the behind-the-scenes work that goes into each and every one of those patients from start to finish.
We are there at the beginning to answer patients’ initial questions: “What is this study about? Why is my doctor telling me that I should consider this study? What are these drugs doing?

How is the therapy different from the standard therapies? How many visits do I have to make? How am I going to feel? How many side effects am I going to have?”

Our job is to put all the information swirling around into perspective so patients can wrap their heads around joining a trial, weighing the pros and cons to decide if it is the right choice for them. And we are not always successful in our efforts; research nurses can spend hours talking to a patient about a clinical trial, and he or she ends up never getting enrolled in the trial.

Simply getting patients comfortable with the idea of participating in a trial is another hurdle. When they hear the word “trial,” patients may feel like lab rats. First-time patients are the most difficult to convince, but once a patient has been in a trial, he or she becomes accustomed to the process and usually wants to continue participating.

The interaction with patients occurs at every level. This becomes even more important for clinical trial patients who are likely receiving an un-approved, investigational drug. With “Dr. Google” on call, we also have to counteract outside forces to provide accurate and trustworthy information, and to direct the patient or the family to good sources outside of the research nurse.

Pulling Double-Duty

In hematology/oncology, it is impossible to unbundle research from routine patient care – so much of what we do for clinical trials is actually administering routine patient care. Patients on clinical trials, though, will often require visits that are above and beyond routine care. Advanced practice practitioners are typically the provider seeing these patients over and over again.

Everyone in the hospital is working under their own time constraints, but that struggle is amplified when adding in the research arena. For instance, take the additional limitations and documentation requirements and add those to regular clinical care, then multiply that manifold to reflect the target enrollment. What you end up with is an incredible expenditure of time and resources.

However, bundling clinical care and research also presents some potential barriers. Because clinical research is intertwined with clinical care, the research team is at the mercy of their clinical system. Regardless of the staff or the institution, the clinical trial can only run as smoothly as the clinical system in which it is being conducted.

In the current climate, every academic health-care center is trying to do more with less. You would be hard-pressed to find a center with a consistently stable workflow over time, so running a successful research enterprise means adapting to changes within that system – whether those are physical changes in the flow of information or changes in the electronic medical record (EMR) system.

For research nurses who also run the data portion of clinical research, the limitations of clinical systems can further complicate and prolong the work. Frequently, recording clinical trials data means entering information twice: The clinically relevant data goes into the patient’s EMR and the documentation required for the trial records is entered separately. That’s a reality of clinical research, and, unfortunately, one without an end in sight.

The Unsung Rewards of Research Nursing

An additional aspect of our jobs, is that the nature of research nursing means we have to become experts on how and why drugs work, in a way that isn’t taught in NP or PA schools. To anticipate the common issues and how the therapies under investigation might affect the disease course, we have to develop a rich understanding of hematologic and oncologic diseases. That in itself can be its own reward.

But is all of the time we devote to research in the end worth it?

One of our clinical nurses who recently took a position as a research nurse put this work in context. After a week in the new job, she went around to every research nurse she had ever worked with and apologized, “I’m so sorry – I had no idea what you were doing. All I knew was what I saw when you were at the patient’s bedside; I had no idea you were responsible for all of these different components.” It was an epiphany for her.

The work we do, while it can be burdensome, is critical to moving science forward and keeping patients safe. It also offers the ultimate reward: the ability to improve the lives of patients for years to come. When, because of the clinical trial you helped with, a drug is approved by the U.S. Food and Drug Administration and becomes standard of care, the sense of satisfaction is extremely gratifying. Most people in health care do not get to experience that.

Research nurses are also fortunate to have the opportunity to forge spectacular relationships with the patients enrolled in these trials. They are an amazing group: While access to investigational and potentially life-saving drugs is enticing, I think they also understand that, regardless of the trial’s outcome, it will add to our knowledge and help improve the lives of all patients to come.

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