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A nurse practitioner in urology

05-07-2013      842 views

A clinical trials nurse is a registered nurse who utilises knowledge of ethics, regulatory and data management aspects of clinical trials, in combination with scientific knowledge and the traditional nursing skills of observation, assessment, patient education and advocacy to care for participants of clinical trials. These nurses adjust their mind-set from a focus on a patient’s individual experience of their disease and treatment, to one that includes how that experience affects the outcomes of a clinical trial protocol, and the future of a potential therapy for the disease involved.

Astute observation of each clinical trial participant and synthesis of the observations across the cohort will enable identification of commonalities that may identify an important medication side effect. Phase three clinical trials investigate a new treatment against the best existing (standard) treatment. Such clinical trials normally involve hundreds of people across multiple research sites. Clinical trial nurses in phase three studies record and report events, administering care with a commitment to the individual patient’s outcome, and to the research question underlying the treatment. Clinical research nurses strive to advocate for their patients while ensuring the integrity of the clinical research.

Patients choose to participate in clinical trials for varied reasons. Some like the way a trial protocol allows them to potentially have access to newer and perhaps more effective treatments than those currently available to them outside of a clinical trial. Others find the thought of more regular check-ups, tests and support from doctors and nurses very reassuring. Others express a wish to contribute to answering a research question to help to improve future treatment for others. All seem to feel that participation means they are doing something positive about their health and taking an active role in their treatment. The nursing role in this process can be very satisfying, providing support, knowledge, advocacy and education to participants and their families, with the longer, more regular appointments allowing for more relaxed interactions and continuity of care.

Dual role
Since 2010 I have had the dual role of Urology Clinical Trials Nurse and Urology Nurse Practitioner at the Waitemata District Health Board, and both positions have provided me with an immense amount of job satisfaction. In New Zealand, Nurse Practitioner (NP) is a legal title for a nurse who has completed advanced education and training in a specific area.

NPs have met the Nursing Council’s requirements to assess, diagnose and manage health conditions. This includes having a clinically focussed master’s degree and demonstrated expertise in the relevant scope of practice. NPs practise both independently and collaboratively to promote health, prevent disease and manage people’s health needs. They provide a wide range of patient assessment and treatments including ordering, conducting and interpreting medical tests, making diagnoses and implementing therapies, to helping manage patient’s health needs. Leadership, integration of research, development of nursing practice and policy are also components of the NP role.

I started my nursing career 26 years ago as a registered comprehensive nurse in the urology and renal ward. My early years of practice and postgraduate study (culminating in a Bachelor of Health Science) prepared me for my first two senior nursing roles in urology- as a clinical nurse educator and as a clinical nurse specialist. The opportunity to learn the skills of a urology clinical trials nurse came later, and as with my other senior nursing roles, was due to opportunity rather than career planning! My passion for nursing and acquiring advanced urological nursing knowledge certainly prepared me for the challenge, but it was my willingness to say “Yes, I believe I can do that and am happy to commit to the learning required that resulted in the successful transition.

The same attitude was required as I pursued further post-graduate study that led to a Master of Nursing degree, and the further development of my nursing role into Urology NP, caring for adults who are undergoing assessment, treatment, rehabilitation and /or on-going surveillance for urological conditions in both in and out-patient settings.

While this evolution in scope of practice occurred, my experience as a Urology Clinical Trials Nurse also progressed. However, as I adjusted to the increase in autonomy permitted by the NP scope, I became increasingly aware of the barriers that prevented me from utilising the full depth of my skills as a clinical trials research nurse. The university where I studied offers a Masters of Nursing programme that is science-intensive and highly focused on assessment and diagnostic skills, pharmacology and prescribing practice. This formal education, along with my experiential learning, ensures that I bring specialist knowledge, critical thinking skills and an in-depth understanding of pathophysiology to my practice, as well as a familiarity with the lived experience of urological diseases. Despite my training, international pharmaceutical clinical trial sponsors do not allow me to be a sub-investigator nor to independently perform causality assessments and serious adverse event reporting as delegated tasks.

What are the rules that govern such decisions? The principal investigator is held responsible for the conduct of the clinical trial at a site and can delegate responsibilities to study staff qualified to perform the tasks assigned. The investigator should maintain a list of the appropriately qualified persons to whom significant trial-related duties have been delegated. This list should describe the delegated tasks and identify the training that individuals have received to qualify them to perform such tasks. Since New Zealand’s nurse practitioner scope authorises the nurse to perform many ‘medical tasks’ independently, it would be considered appropriate for the clinical investigator to delegate to him/her such clinical trial tasks.

As long as the nurse practitioner is performing tasks for which he/she is qualified, it would be considered unnecessary for the clinical investigator to sign off on his/her notes. It would however be expected for drug and biologics studies, that the nurse practitioner be listed on the FDA Form 1572 so that the sponsor is aware that he/she is playing a major role in the conduct of the study at that site. Nurse practitioners would be required to meet the same regulatory requirements as other investigators. These include having a CV on file including credentials and appointments, and demonstration of GCP and ethics training.

With pharmaceutical clinical trials, sponsors vary considerably in what tasks they will allow NPs to do. At present, the requirements of a specific sponsor override local ‘scope of practice’ regulations. A protocol may specify the qualifications of the individuals who are to perform certain protocol-required tasks (e.g., physician, registered nurse), in which case the protocol must be followed even if local laws permits individuals with different qualifications to perform the task.

For example, if the country/state in which the study site is located permits an NP to perform physical examinations, but the protocol specifies that physical examinations must be done by a physician, a physician must perform such exams. Until recently this has been the case at our research unit, but I am pleased to report that this month, for the first time, an American prostate cancer pharmaceutical trial sponsor has allowed me as a nurse practitioner to perform physical examinations as a delegated task.

What of Nurse Practitioner as a principal investigator (PI) for a research study? The minimum requirements for a PI are based on the risks involved in the research project. The PI must be qualified by education, training and experience to assume responsibility for the proper conduct of research study and should meet all qualifications specified by the applicable regulatory requirements. Large multi-centre international pharmaceutical clinical trials such as the prostate cancer and Peyronie’s protocols I have worked on are generally high-risk endeavours which are not suited to NP preparation, in my opinion. New Zealand protocols that are deemed minimal risk studies are a more promising prospect for this urology NP! I wonder if my EAUN urology / research nurse colleagues have the same dilemmas. I would be interested to hear your thoughts.

Sue Osborne

Urology Nurse Practitioner
Waitemata District Health Board Dept of Urology
Auckland (NZ)


Article from European Urology Today, volume 25, No. 3

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