Nursing Role in Clinical Trials

Clinical trials are vital to the nursing industry as they essentially provide the evidence to support what nurses do on a day-to-day basis. On the other hand, nurses are also crucial to clinical trials, and their involvement is paramount to a successful outcome. The COVID-19 pandemic has forced the scientific and medical communities to rethink how they operate clinical trials, with many institutions opting for decentralized clinical trials over standard clinical trials.

The nurse’s role is even more critical when one thinks of a new clinical trial system that takes the trial to the patients as opposed to the patient coming to the hospital. Nurses, whether staff nurses or clinical trial nurses, provide comfort and care to patients participating in clinical trials. They’re also responsible for ensuring that patients consent to the trial and that patients adhere to the rules of the trial for their own safety.

There are two types of nurses involved in clinical trials. Let’s look at their respective roles in these trials.

Clinical Trial Nurse

Clinical trial nurses have important responsibilities during trials. Some of the job titles in a clinical trial team are research nurse coordinator, clinical research nurse, or clinical research coordinator. Clinical trials nurses serve as a sort-of trial coordinator, a job that includes liaising and communicating between the lead researcher and the site-specific assessment office, and working with clinical and non-clinical managers, clinicians, governing bodies, and trial participants to ensure everything runs smoothly.

Clinical trial nurses are vital for the forward motion of the trial, as they help prevent delays in the completion of certain studies or tests, and they answer research questions that keep the project moving forward and benefit science as a whole.

A typical day in the life of a clinical trial nurse consists of board reviews and meetings with essential personnel about the trial, ensuring all staff and patients follow trial protocols, meeting with the care team to review labs, test results, and any events worth noting. They organize calendars, pill diaries, lab orders, and teaching materials, as well as quality-control checking the data manager’s entries. Clinical trial nurses are a key cog in the machine of a clinical trial.

Staff Nurse

Staff nurses, like clinical trial nurses, are critical to the research process. They have direct, regular contact with the trial participants, which allows them to form a bond of care and compassion with the participant more than anyone else on the research team can. They administer investigational medications, perform detailed clinical assessments, collect research samples, and provide additional or specialized care based on a participant’s response to a trial method. The staff nurses are in the room when a patient is administered an investigational medicine, and they observe and report any adverse events or phenomena that occur in the patient.

Along with care and observance, staff nurses are also responsible for educating patients about what the trial is about and all the protocols of the study to ensure that they fully understand what they agree to and are fully equipped to handle any possible side-effects or adverse events. Staff nurses also deal with the documentation and consent of the patient and provide valuable insights and information to patients throughout the trial, such as education about the study, standard-of-care medications, and schedule of testing.

Collaboration and communication between staff nurses and clinical trial nurses are absolutely key when looking at the process and roles of nurses in research studies. Staff nurses will constantly check in with the patients to see how they are feeling during the trial and then will document these findings as well as any other noteworthy events that may have taken place. The nurses will then consult the physician and communicate their information as needed.

Combined Roles

As much as staff nurses and clinical trial nurses have differing roles, they do have shared ones, too. One of these roles is the responsibility of making sure that there are no barriers to participation in these trials and that anyone willing to participate is made to feel comfortable and at home, which assists in the retention of participants.

Another one of these combined roles is ensuring that patients adhere to the rules and protocols of the trial, with some of the main reasons for nonadherence being misunderstanding the protocol process, forgetfulness, and lack of awareness about the importance of taking medication as prescribed. Both types of nurses are responsible for the rectification of this in patients.