Clinical trials are the backbone of medicine. They ensure that new treatments are both safe and effective, not only potentially improving the conditions of patients but also saving lives, now and in the future. Over the years, clinical trials have led to some of the greatest medical breakthroughs, including the recent mRNA vaccines for COVID-19. And at Penn Medicine, clinical research is a huge enterprise. At any given time there are more than 3,000 active clinical research studies with over 130,000 patients enrolled.
Penn Medicine’s 1,200 clinical research professionals — which includes members of clinical trial research teams — work together to advance the science of clinical care, provide access to innovative therapy and improve clinical outcomes.
To some patients enrolled in clinical studies, a clinical research nurse (CRN) might seem like just another nurse on their care team — but in fact a CRN plays a complex and pivotal role in the care of research participants in the hospital and clinic and behind the scenes.
“Their clinical nursing practice knowledge combined with expertise of the principles and practices of clinical research serve a critical need on the collaborative multidisciplinary care team,” said Maria Hendricks, MSN, RN, director of Clinical Research Operations at the Abramson Cancer Center’s Clinical Research Unit (CRU) in the Perelman School of Medicine at the University of Pennsylvania.
The Many Hats of the CRN
CRNs wear many hats during a clinical trial but one of the most important is making sure everything in the trial adheres to strict regulatory and safety requirements to ensure the trial is conducted as planned and patients are protected. Indeed, if the principal investigator (PI) deems it necessary to prescribe an additional supportive medication, the research nurse checks the protocol to make sure it’s allowed.
Critical thinking is key for many aspects of the job. Research nurses collect and assess data from the trial. CRNs oversee the investigational drugs given to patients and monitor for side effects and complications to safeguard the participant, documenting all information. Keeping tabs on appropriate lab tests is especially important for studies of an investigational drug, said Terease Waite, PhD, RN, MBE, program manager of Education and Training at the CRU at Penn. “Some drugs might affect a patient’s liver so we have to make sure liver functions are good. The CRN has to make sure all appropriate labs are finalized and reviewed by the PI before a research participant receives treatment,” Waite explained.
The CRN is integral to maintain communication among all team members while the patient is taking part in a clinical study, said Amanda Brock MSN, MBE, associate director of Clinical Research Nursing and Training in the Perelman School of Medicine, Office of Clinical Research. “The CRN keeps everyone up to date, communicating, coordinating, and making sure things happen when they need to happen.”
There is often a misconception that CRNs do not have patient contact. But, in fact, the nurse-patient relationship was cited by many CRNs on a survey as the most satisfying part of their role. CRNs are often the first members of the research team to meet research participants, screen them for their eligibility for a trial, and are involved in the consent process. The CRN is responsible for serving as patient advocate for all matters related to study participation.
In short, the CRN is essential to the continuity of care for patients in clinical trials. “It’s about collaborating to maintain the integrity of the research protocol and safeguarding the participant to answer important questions to advance care,” Hendricks said.
In her role as CRN prior to her current role overseeing education and training, Waite held information sessions, with handouts, for inpatient bedside nurses who would care for the research participants. “They were an opportunity for me to provide information about the trial, labs needed to be drawn, information about the investigational drug and what to expect, as well as a time for these nurses to ask questions.”
The connection with patients who take part in trials at ambulatory care settings is just as strong. As an ambulatory CRN, Waite not only greeted her research participants in the waiting room — and waited for them to have labs drawn — but she also was involved in the actual clinic visit, performing assessments and answering their questions, especially about the protocol.
Answering questions is a big part of the job, as the CRN serves as the communication link between the PI and research participants. “So much information is thrown at study patients, in so many different ways. It can be overwhelming,” Brock said. “The science behind the study, the importance of additional blood draws, additional hours needed to be monitored, additional visits to collect data required for trial … CRNs explain things in ways patients can understand.”
In many cases, the bond that develops during the trial continues after the research therapy ends and the CRN has circled out of the patient’s care team. Many nurses who move on to other positions even maintain communication with patients for years. “With some trial participants, we see study patients who had run out of treatments and were going to hospice. But with the trial they survived against all odds,” Brock said. “Seeing patients meet milestones in their lives that may not have been possible without an investigational intervention — like graduations, weddings, and having grandchildren — is very rewarding.”
“I still receive emails and texts from my research participants, telling me how they’re doing,” Waite said. “And if they are back for a clinic visit, they look for me and tap me on the shoulder to say hi!”
The Many Pathways for CRNs
Many CRNs receive on-the-job training. The ACC CRU offers a central education and training program to support the nurses, which will be expanded to include opportunities to “shadow” ambulatory oncology infusion nurses at the Perelman Center for Advanced Medicine.
Brock is now in the early stages of discussing CRN education with the Penn School of Nursing, seeking to create a partnership to educate undergraduate nursing students about the CRN specialty area.
Practicing CRNs are also in a perfect position to move into the nurse researcher arena. They care for patients and not only see the processes during a clinical trial but also “where to improve them,” Waite said, “and that’s a possibility for research.”
When Waite took her current position, she wanted to spread her love of research. She is in the process of developing a learning module for all of the CRU research staff, starting at the beginning: What is research?
She’s also leading an initiative called #ResearchOnResearch, empowering CRU research staff to pursue and to develop research projects based on their clinical research experiences and academic interests.
This past spring, Waite rallied a number of CRNs to share their work with others in their field via research posters at the International Association of Clinical Research Nurses (IACRN) conference being held in the fall, thanks to a tip from Hendricks, who had submitted a poster proposal of her own. Waite sought out members of the CRU research staff who had noteworthy projects: She learned of one research team that had created a process to improve the amount of time it took PIs to verify notes. Another research team was working on a spreadsheet to analyze what populations were being recruited in the study, to help decrease disparities. She found another possibility in the CRU Ethics Journal Club — which she oversees — about ethical issues affecting staff.
Although the teams were eager to submit their work, they did not know how, so Waite coached them through the process of writing and submitting the abstract to propose their poster topics. When all four abstracts were accepted for poster presentations, she assisted the two research groups in developing the posters for their presentations.
At the IACRN conference in October, the CRU poster analyzing participant disparities in studies was awarded third prize, for its “excellence in clinical research nursing specialty practice and innovation in problem solving.”
But, even more exciting, the experience introduced the research teams to new possibilities. Said Evan Anderson, BSN, RN, OCN, “From initial identification of an area that needed improvement, to project implementation, and finally reporting our outcomes, the entire journey has given us deeper insight into how quality improvement can be conducted and the scope of its impact.”