Who’s responsible for ensuring a successful oncology clinical trial? A scientist, physician, clinical data manager, or study coordinator probably comes to mind — but an oncology nurse also plays an integral role.
Oncology clinical trials provide the evidence needed to develop new treatments and improve existing therapies. In the realm of oncology, clinical trials are especially crucial as they offer hope to patients battling cancer.
The Oncology Nursing Society outlines competencies and functions of oncology nurses and other nursing professionals involved in clinical trials in their Manual for Clinical Trials Nursing (Third Edition). Here we explore some of the main roles of an oncology nurse in clinical trials.
Multiple roles for an oncology nurse
Oncology nurses play a key role in the success of clinical trials. Here are four responsibilities of an oncology nurse:
1. Patient education and informed consent
Before a patient can participate in an oncology clinical trial, that person must fully understand the study’s purpose, procedures, and any potential risks or advantages. An oncology nurse plays a critical role in this process by providing clear, comprehensive information to patients and their families.
First, the oncology nurse explains the clinical trial in detail, covering the study objectives, the type of treatment or intervention being tested, the duration of the trial, including the phases, and the expected outcomes. An oncology nurse ensures patients are aware of what’s expected of them as study participant. (Tests? Treatments? Follow-up visits? If so, how many and where?)
Patients may ask questions, such as, “How severe might the side effects of an experimental treatment be?” “What measures will be taken to manage them?” when weighing whether to participate in a clinical trial. The oncology nurse is often the best healthcare professional to address these queries, providing reassurance and clarity on what to expect.
Obtaining informed consent is a crucial step in enrolling patients in clinical trials. Patients might be interested in potential benefits (such as the possibility of having access to the latest therapies before they’re widely available). However, the oncology nurse must ensure that patients fully understand what they’re consenting to, and that they do so voluntarily, without coercion.
2. Treatment administration and monitoring
Once a patient is enrolled in a clinical trial, the oncology nurse is responsible for administering the investigational treatment and closely monitoring the patient’s response. This involves a range of tasks that require precision, attention to detail, and a deep understanding of oncology care.
Oncology nurses are trained to administer a variety of treatments, including chemotherapy, immunotherapy, targeted therapy, and experimental medications. They follow strict protocols to ensure treatments are given safely and correctly. Nurses must calculate dosages, prepare the medication, and monitor the patient during administration.
That’s true for any cancer patient undergoing treatment, but what’s different about oncology clinical trials is that new or experimental treatments are often involved. In some cases, the treatments being studied have unknown side effects. An oncology nurse closely monitors patients for any adverse reactions, both during and after treatment. Nurses also recognize and manage side effects, providing immediate care and adjusting the treatment plan as necessary.
3. Collecting and recording data
Oncology nurses’ meticulous data collection is essential for generating reliable, meaningful research findings. The oncology nurse meticulously records all aspects of the patient’s treatment and response, including vital signs, laboratory results, and any side effects.
For instance, the nurse might document that a study participant developed a red, itchy rash on both forearms two hours after receiving an investigational medication. This type of detailed data is crucial for assessing the safety and efficacy of the treatment being studied.
4. Patient advocacy and support
An oncology nurse offers compassionate support, empathy, and encouragement to participants throughout the clinical trial process. The oncology nurse also acts as an advocate for patients, ensuring that their preferences are respected. For example, a patient might strongly prefer home-based monitoring instead of in-clinic visits due to work schedules or transportation difficulties.
5. Ensuring compliance and protocol adherence
Clinical trials are governed by strict protocols and regulations, to ensure patient safety and to protect the integrity of the research. The oncology nurse plays a key role in ensuring all those requirements are followed meticulously.
Each clinical trial has a detailed protocol outlining the study’s procedures, treatment schedules, monitoring requirements, and other significant details. Oncology nurses are responsible for adhering to these protocols, which include following specific guidelines for treatment administration, patient monitoring, and data collection.
Clinical trials must comply with various regulatory requirements, including Food and Drug Administration regulations that oversee human subject protection. Institutional Review Boards are also responsible for evaluating the ethics and safety of research/clinical studies involving human subjects. To ensure the clinical trial is in compliance, the oncology nurse maintains accurate records and reports any adverse events promptly.
6. Conducting follow-up assessments
The oncology nurse conducts regular follow-up visits to evaluate the long-term effects and efficacy of the treatment being studied. Nurses assess patients’ health, record any changes in their condition, and ensure that follow-up procedures are carried out according to the study protocol.
7. Helping to design clinical trial study protocols
Many oncology nurses are actively involved in research, bringing a practical, patient-centered perspective to the study design process. Nurses’ frontline experience gives unique insights as to potential challenges and logistical issues. Their input ensures that study protocols are feasible and patient friendly.
For example, oncology researchers may initially expect all participants to visit the clinic twice a week for infusions and monitoring. However, the oncology nurse, drawing from their experience with patients, identifies that frequent visits may be overly burdensome for some people.
In this scenario, the oncology nurse can suggest modifying the protocol to consolidate the visit schedule. Instead of two separate visits per week, patients can have a single visit for both infusion and monitoring. Additionally, the nurse can recommend incorporating home healthcare services for blood tests and vital sign checks, further reducing travel burden.
By recommending changes like these, an oncology nurse makes it more likely people are able and willing to participate in a clinical trial. Good study design improves patient recruitment, retention, and adherence. In turn, that results in higher-quality data and more reliable clinical trial outcomes.
The impact of oncology nurses on clinical trials
Nursing involvement ensures that oncology trials are conducted safely, ethically, and effectively. An oncology nurse is essential in building trust between patients and the research community. Through their clear communication about what to expect, the oncology nurse helps patients feel confident in their decision to participate.
By sharing their unique expertise to inform the design of study protocols, oncology nurses make clinical trials more patient centered. Ultimately, this contributes to the development of new therapies that improve patient survival and quality of life.
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