Every clinical trial has a Principal Investigator PI who is accountable for the overall conduct of the trial and will enroll research participants. Other team members may include: sub-investigators, study coordinator nurse or non-nurse , clinical data manager, and statistician. The types of individuals and responsibilities vary based on the clinical setting. Table 4 outlines the general responsibilities of the PI, study coordinator, and research participant.
The oncology nurse needed to develop new skills and new partnerships with physician investigators while caring for patients on clinical trials. This not only included administering investigational agent s but also coordinating the clinical trial. In addition to the responsibilities of the study coordinator listed in Table 4 , the oncology CTN will:. Understand the basics of genomics and molecularly targeted therapies including implications for participant education and informed consent.
Advocate for the patient i. Include new functional areas e. Add a more advanced level of competencies for those with more experience or who are functioning at a higher level than the novice CTN. Historically the management of CTNs fell within the specific programs including CTN recruitment, supervision, training, personnel actions, and performance evaluations.
The programs were silos in which the team functioned. As the workload of one program grew there was little to no flexibility to have CTNs cross-cover from another program.
The scope and volume of work was discrepant across programs. When programs expanded their research portfolio necessitating more CTN staff, the request was forwarded to the OCD for evaluation and approval. There were no standard performance evaluation metrics.
Work practices for leave and attendance and telecommuting were different across programs. Communication practices were not efficient or timely. The primary purpose was to allow nurses to report to nurses in the hopes of:. A number of town hall meetings for CTNs and PIs were held in Fall to present the idea for a new model and to elicit feedback from these stakeholders. Building the infrastructure for this office took place between September and March The ORN was given a budget to include salaries, travel, training and supplies.
A Chief needed to be recruited for the office and three team leaders needed to be hired into the ORN. The team leaders selected had a strong background in research nursing, leadership and a strong institutional knowledge. A leadership team formed and an administrative assistant hired with responsibilities for travel, supplies, management of timecards, and facilitation of the recruitment and hiring processes.
Performance evaluations were created using the ONS Competencies. The ORN Chief believed that the consolidation of nursing under nursing leadership would have the potential to develop quality CTNs to support clinical research within the organization. In order for the new model to be successful, the Chief needed to lead change by engaging clinical research staff in a mutually supported vision of the future while being sensitive to the cultural change experienced by the CTNs and the PIs.
Create ways for people to get together and converse. Get them participating, engaged, and involved. This is the road to personal investment, enthusiastic support, and genuine buy-in. On the first day in office, the Chief made appointments with each one of the 74 CTNs and interviewed them to understand their background Box 5 , motivations, and career aspirations.
CTNs were asked:. Overwhelmingly, the CTNs said that what kept them in their jobs were the relationships with their colleagues including investigators and other physicians.
They felt intellectually challenged by the research protocols and science, autonomous in their positions, and driven to help patients. The overriding impediment related to performing their jobs better was a lack of communication about policies and procedures. They wanted to know best practices and what other nurses were doing that improved their efficiency.
Much of the information gained from these interviews was congruent with the reasons for the reorganization of the CTNs. This was a key first step to engaging staff in decision making for what was to be a long-term meaningful partnership between leadership and staff. To provide a unique, cohesive team of superior research nurse specialists to carry out the mission of the CCR through a culture that supports continuing education, mentorship, professional development, and collaboration while balancing comprehensive patient coordination and quality clinical and translational research.
The leadership team participated in a 12 week supervisory course on self-development, program development and leading though change. Training included the legalities of supervision, conflict resolution, leadership development, forming and leading teams, and handling human resource issues.
In addition, the Chief and team leads were afforded the opportunity to have three months of individual executive coaching which has proven to be invaluable for the development of the ORN. The ORN established four teams each with a team lead Fig 1. The ORN leadership took the following into account:. Research team workload e. The aim was to provide manageable teams for each team leader to supervise while supporting the vision statement of the ORN.
The newsletter is distributed via email and posted on a dedicated website. The purpose of these meetings is for staff to network, share best practices and receive up-to-date information from the leadership team. The CTNs are invited to join the meetings but not required to attend the meetings. Part of the communication plan includes the development of the ORN Wiki page.
The site is maintained by the ORN Chief and contains: newsletters, listing of the nurses, their contact information, and procedures for promotion. An email distribution list with all research nurses, ORN leadership, and additional staff from the Office of the Clinical Director e.
Each team leader developed relationships with their CTNs, the teams in which the team leaders worked, and the respective PIs. It was imperative to know what each individual on the research team valued and find ways to help them achieve that as quickly as possible. The team leaders attended research team and data management meetings as well as clinic when needed. The team leaders continue to meet regularly with PIs.
Quickly workgroups began to emerge comprised of staff who identified a need or a problem and developed a team to address solutions. One workgroup emerged to address documentation needs in the electronic medical record. Others workgroups developed including:. Journal Club to provide CTNs with a forum to discuss peer-reviewed literature related to oncology, nursing or clinical trials. Model for cross-coverage and what it meant to cover for a CTN who was out of the office.
From its inception the ORN leadership made a strategic decision that changes in practice would be small with a likelihood of being successful and that we would build from there.
It was about building trust and respecting staff input. A decision was made that all changes would be presented to the staff with rationale for the change; they would have input; and leadership would listen. The principal investigators and other stakeholders were included in the communications.
We would communicate to the staff the final proposal and then roll out the changes and fully communicate to all involved. The first change that was presented was standard operating procedures SOP for time, attendance, and telework. This process was successful, as the staff trusted the process allowing for subsequent changes. We established ground rules for conducting business including work schedule options, performance evaluations, and promotion procedures.
All changes were approached in the same manner of our change management philosophy. A priority of the CCR was to improve cross coverage and flexibility to cover workload. There were 4 programs that included only one CTN. We also identified the need to have a senior resource CTN who could be deployed to teams for various reasons e. This resource CTN was available to precept new staff. The process was evaluated by leadership and senior staff who had previously gone through the process.
Feedback was elicited from staff and the process was finalized. There are 5 nurses promoted using the new promotion process incorporating a leadership initiative as part of their senior CTN status. New CTN orientation has been redesigned. Each new CTN is assigned a preceptor. New CTN orientation procedures and standardized checklists have been developed to guide the new CTN and their preceptor. The best way I have found to help is just to educate the patient by talking to them about what may happen and what the possibilities are.
It is a big event. There are a lot of unknowns. I think all of us realize that the anticipation is almost always worse than the actual event. Education is key. We talk about that because those consent forms can be overwhelming. When we go over those consents, I try to help the patient understand which ones are the most common, that they are likely to see or that they will see.
Everyone has had this happen. TE: Are there any closing thoughts that you might have for patients that are considering clinical trials and maybe what to look for or how to ask their doctor about how to get into a clinical trial? Nationally, there are very few patients who go on clinical trials. Just the idea that the patient is interested in a clinical trial is great. There is the www. Also, just asking their doctors about it is a way to find out about trials. We have a number of patients even in San Diego which is close to an academic medical center.
I want you to get me into it. TE: Thank you very much for your insights on clinical trials and continue the good work. I was watch and wait for over seven years. During those seven years I had minimal symptoms and the major issue was my increasing white blood count WBC , which by September had increased to over , People with poor prognostic markers, like 11q deleted 17p, ZAP 70 positive, and unmutated have a much poorer prognosis. I have ALL of these makers and here I still am.
Now, 14 years later I am still going strong, and expect to be here another The Role of the Clinical Trial Nurse. March 17, This phase typically involves less than 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 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:. As it includes all advanced practice competencies, clinical research nursing involves decision making and concrete thinking.
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.
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