The Nurses’ Role in a Clinical Trial: Everyone Is Involved
Nurses can serve in a variety of roles when it comes to clinical trials — from being a research nurse or a vital piece of the multidisciplinary team, according to Maria Hendricks, MSN, RN.
“Each and every one of you is involved in the care of a research patient. Your role is integral in the success of how we treat our patients moving forward,” Hendricks, director, clinical research operations, Abramson Cancer Center, Clinical Research Unity, University of Pennsylvania in Philadelphia, said during a presentation at the 3rd Annual School of Nursing Oncology.
Clinical trials are designed to study new drugs that are not yet approved by the FDA; new uses of drugs that are already FDA approved; new ways to administer the drugs; use of alternative medicines; new tests to find and track different cancer types; and drugs or procedures that alleviate symptoms.
Phase I studies are intended to find a safe dose of the drug, to decide how the new treatment should be given, and to see how the new treatment affects the patient and treats their respective cancer. This phase of studies typically includes 15 to 30 patients.
Phase II studies determine if the new treatment has an effect on a certain type of cancer. They also evaluate how the new treatment affects the individual and their disease. This phase typically involves less than 100 patients.
Lastly, phase III trials are designed to compare the new treatment, or new use of said treatment, with the current standard treatment, with or without placebo. This phase involves anywhere from 100 to several thousand patients.
The multidisciplinary care team on a clinical trial includes a physician (principal investigator or sub-investigator) and an advances practice provider, including:
- Nurse Practitioner (NP)
- Physician Assistant (PA)
- Clinical Research Nurse (RN)
- Clinical Research Coordinator (CRC)
- Pharmacist/Pharmacy Technician
- Biospecimen Coordinator
- Regulatory Coordinator
- Research Assistant (RA)
Clinical Research Nursing
As it includes all advanced practice competencies, clinical research nursing involves decision making and concrete thinking.
“It is a key focus of study management, human subject protection, care coordination — which is very complex when it comes to trials. Overall, it contributes to science in addition to using baseline clinical practice knowledge for the support and care of an oncology patient,” Hendricks explained.
In particular, there is a difference between a research nurse and a nurse researcher — roles that often get confused with one another. A clinical research nurse contributes to science with a focus on the care of the research participant and the coordination of research activities in a research practice setting, Hendricks explained. Meanwhile, a nurse researcher provides a significant body of knowledge to advance nursing practice, shape health policy, and impact the health of patients, she added.
The role of the research nurse includes determining consent and screening; eligibility criteria; treatment; grade and attributing toxicities; dose modification; concomitant medications; disease response; and deviation reporting.
“The research team of nurses is a key piece to be aware of. There is some additional training that is required. There is some education around what it is to do good clinical practice when it comes to the care of a research patient,” Hendricks said.
“It is taking a look at financial disclosures. It is making sure there is appropriate training about what happens on the study,” she added.