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Lack of time is the most common reason oncologists give for not participating in clinical trials. The development of a research team can help overcome this barrier and enable an oncology practice to make clinical research a priority. ASCO recognized the essential role of a clinical research team by presenting its 2006 Clinical Trials Participation Awards (CTPAs) to entire research teams within 12 community oncology practices. Each of the award-winning practices has integrated a team approach into daily practice, with members of the team assuming specific tasks to free up time for oncologists.
The composition of research teams varies, but the goal for all is the same: alleviate the burdens of clinical trial participation for oncologists. “Physicians are interested in participating in clinical trials, but support staff is needed to make it work,” says Marge Good, RNT, BSN, MPH, OCN, Manager of the Wichita Community Clinical Oncology Program (CCOP), one of the CPTA recipients. “We make it easier for a physician to enroll a patient on a trial than not to,” she adds. Anthony Greco, MD, of Tennessee Oncology, agrees, noting, “Busy oncologists need considerable assistance to recognize appropriate patients for trials as well as to obtain all the required studies, therapy, and follow-up. The research staff gives this necessary assistance.” As a result, says Greco, “Clinical research is recognized as an integral component of excellent oncologic care, and our oncologists know that they can offer many important treatment options for their patients.”
According to Good, having sufficient staff is essential to continue high rates of accrual while maintaining data submission timelines. The 20 oncologists in the Wichita CCOP are supported by 17 nurses and data managers, as well as 13 non-nursing support staff. Members of the team can include clinical research nurses, non-nursing clinical research associates, data managers, regulatory staff, and administrative support staff. A research coordinator, who is usually broadly experienced with both clinical research and with the practice's operation, often oversees the team. Members' roles and responsibilities vary according to the overall composition of the team. The key, says Beth LaVasseur, Oncology Research Manager at St Joseph Mercy Hospital Cancer Program (Ann Arbor, Michigan), is, with appropriate privacy permissions, to integrate the research staff into the practice, “with complete access to patients, their records, and the assistance of other practice staff.”
Identifying patients who are eligible for a clinical trial is perhaps a research team's most important contribution to increasing accrual. All of the CTPA recipients noted that their efforts to enhance accrual began with the development of strategies to identify eligible patients. “As new studies open, our research teams tailor recruitment strategies and screening tools to ensure that every eligible patient and his or her physician are aware of clinical trial options,” says LaVasseur. As an example of a tailored strategy, she explains, “Let's say we get a bone scan report that shows a patient has bone metastasis. The nurse will look for appropriate trials and attach a note to the report before the oncologist reviews it.”
The screening system at St Joseph is similar to that of the other practices honored with a CTPA. Clinical research nurses routinely evaluate new patients' medical records before the first visit with the oncologist and attach a note about potential trials for which the patient may be eligible. Robin Zon, MD, of Michiana Hematology-Oncology, PC (South Bend, Indiana; which provides leadership for the Northern Indiana Cancer Research Consortium [CCOP]), adds that research nurses review medical records on a continuing basis to determine if patients become eligible for second-line or third-line treatment or for symptom management trials. Members of other research teams attend multidisciplinary tumor conferences to identify patients for protocols as well as to provide physicians outside the practice with information about the availability of trials.
In addition, many of the CTPA-recognized practices have empowered research nurses to assume more responsibility. For example, nurses at some practices can write orders that the physician reviews and approves before being implemented or can talk to patients directly about symptom management trials. At St Joseph, says LaVasseur, “The research nurse introduces the trial with ‘Your physician asked me to call you about a clinical trial option.’ The nurse can take more time to explain the study in detail, which ultimately leads to increased accrual.” This approach led to the random assignment of 43% of women who were contacted by research nurses at St Joseph for one study.
Increasing awareness among patients also aids in accrual and compliance. Many of the practices have developed educational resources about clinical trials that they place in the waiting room. “We post signs describing trials for the palliation of cancer symptoms in the waiting room,” says Thomas Saphner, MD, of Green Bay Oncology (Green Bay, Wisconsin). “The medical assistants and infusion nurses are briefed on symptom management trials so they can discuss these options with the patients and/or caregivers before and after the oncologist visit.” The research team at St Joseph has developed study-specific flyers and a general information brochure, “Is Your Cancer or Cancer Treatment Causing Symptoms?” The brochure has been added to the new-patient packets and is distributed in waiting rooms throughout the cancer center.
Patient advocates can also help increase accrual by educating patients about clinical trials and sharing their own experiences. Carle Cancer Center (Urbana, Illinois) has begun to rely on patient advocates to help increase awareness and support for clinical trials. Two advocates are available to help patients better understand clinical trial options. The advocates, who are networked in the North Central Cancer Treatment Group (NCCTG) patient advocate committee, are in the process of planning fundraisers to support various items needed by patients undergoing cancer treatment and creating a newsletter about the patient and support services at Carle.1
The research team assumes a variety of other responsibilities to support the practice's participation in clinical trials. “Physicians can feel overwhelmed with the minutiae of protocol compliance,” says Kendrith Rowland, MD, of Carle. “The increased availability of well trained CRPs [clinical research professionals] to the physicians and the greater involvement of CRPs in patient care have made the physician experience much less stressful.” Clinical research nurses can ensure that protocol requirements are met, that follow-up tests are ordered and completed, and that physicians are notified when dose modifications are needed. Non-nursing members of the research team can send specimens, track patient visits, and complete data forms (Table 1). The research staff at St Joseph has developed tools such as toxicity grids and easy-to-read individualized test schedules that allow for more accurate and efficient source documentation.
Research teams also play a significant role by helping oncologists have convenient access to updated clinical trial information while seeing patients. Quick, easy access to clinical trial information helps physicians to explore clinical trial options with their patients. Each of the award-winning practices follows a process for developing updated lists of open clinical trials, selection criteria, and protocol information. These lists are made available in pocket-sized brochures or cards, on password-protected intranet sites, by e-mail, and are distributed to physicians and staff.
Logistical elements can help a research team work more efficiently. “The clinical research associates' offices are located within the same space as the physicians' offices to promote informal communication, interaction, and cooperation,” says Saphner. For practices with multiple sites, a decentralized staffing model also works. The Warren Cancer Foundation (Tulsa, Oklahoma) adopted such a model, moving research nurses to the largest oncology practice sites within the foundation. “The pilot program, the Expanded Research Nurse Role, was instituted to place research nurses at the physician's elbow,” says James Lockhart, MD, a physician in the foundation. “The benefits of this approach are a reduced workload for clinic staff and a process of continuously screening patients for eligibility,” he adds. “This horizontal integration has been phenomenally successful; physicians have doubled their accrual and attribute the change to these efforts.”
To meet the challenge of establishing a research culture across 13 locations and a large geographic area, the Rocky Mountain Cancer Center (Greenwood Village, Colorado) assigned research staff to each location. In discussing this initiative, Joni Newman, RN, BSN, OCN, Director of Research Operations for the practice comments, “The presence of dedicated staff in each location, as well as the selection of a physician research leader or champion for each site, has led to the successful integration of the research program into the everyday lives and practices of everyone involved.”