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“Clinical trials should be the centerpiece of a practice,” said Daniel M. Hayes, MD, of Maine Center for Cancer Medicine. “Each practice should have an internal clinical trials program that is part of its quality experience, part of its educational and patient care mission. These elements cannot be separated from practice core activities.”
An oncologist in an 11-person independent group, Dr. Hayes has been involved in clinical trials for several years. However, he said, “We were underutilizing our resources, and patient enrollment varies among the physicians in the group.” At the request of his research nurse, they attended ASCO's Clinical Trials for the Community Oncology Team workshop, held last October in Dallas, Texas, to learn how the practice could enhance efficiency and increase accrual.
Dr. Hayes and his research nurse, Barbara Wood, RN, made up one of 50 teams chosen to attend the ASCO workshop, which drew nearly twice as many applications as available slots. The workshop was designed for physician-research staff teams, recognizing the importance of the multidisciplinary team to the success of a clinical trials program. In selecting attendees, the Steering Committee reviewed applications that included an essay on why the applying team wanted to attend, a summary of the clinical trials record, and a description of the practice. “The overriding criterion for selection was commitment,” said Ian Tannock, MD, PhD, who served as Chair of the Steering Committee and as faculty for the workshop. “We targeted the workshop to community oncologists who had some motivation to do clinical trials and had had experience with them. We didn't want attendees who were already very successful at it—we wanted physicians in the middle,” said Dr. Tannock, who has been involved with clinical trials in an academic setting for 25 years.
Until about 20 years ago, the development and accrual of clinical trials were done strictly within academic centers. However, a large majority of patients with cancer are treated in the community setting, yielding a potentially large untapped pool of trial participants. Community oncologists can therefore play a pivotal role in increasing clinical trials enrollment from its 3% to 5% rate, and ASCO is seeking ways to help physicians improve participation in clinical trials.
“The overarching goal of the workshop was to educate the teams about how to develop, integrate, and conduct clinical trials in the community setting by focusing on barriers to doing research and then developing strategies to overcome these barriers,” said Robin Zon, MD, who also served on the Steering Committee and as faculty for the Dallas workshop.
Reflecting the team approach, ASCO developed the workshop in conjunction with the Oncology Nursing Society (ONS) and the Coalition of National Cancer Cooperative Groups (CNCCG). The workshop provided an opportunity for attendees to learn from researchers from the National Cancer Institute (NCI) and representatives from the Cooperative Groups, as well as from other community physicians who have had success with clinical trials, including two physicians from community oncology research groups who have received ASCO's Clinical Trials Participation Awards: James N. Atkins, MD, of the Southeast Cancer Control Consortium Community Clinical Oncology Program (CCOP), and Alan P. Lyss, MD, of Missouri Baptist Cancer Center (see textbox).
Dr. Hayes said he was “very engaged” at the conference and learned a great deal about ways to enhance the clinical trials process. Also, he said, “I learned that every practice has the same problems—there are ‘superusers’ and physicians who don't enroll any patients, and demographics don't matter, whether it's a community, hospital-based, or an institutional practice.” He added that barriers to enrollment remain a problem and physicians should continue to discuss ways to overcome them.
The barriers to clinical trial participation have been well documented, and they differ slightly for community clinical research and for academic institution research, according to Dr. Lyss. In his workshop presentation, he noted that for community practices, the barriers are mostly related to financial issues, including direct costs (staff, office space, office equipment) and costs related to lost time (discussing trials with patients, reviewing studies, complying with trial requirements, attending meetings, etc.).
Motivations also differ for academicians and community physicians. In earlier work, Gary I. Cohen, MD, who served as faculty for the workshop, wrote, “Academicians perform studies to test innovative ideas. Community physicians are primarily motivated to improve care for their patients and to provide continuing treatment in the office setting.”1 At the workshop, Dr. Lyss echoed this belief, noting that physicians′ increased awareness of current treatments and new options through work in clinical trials result in better patient care. Another advantage, he said, is professional growth through education at national group meetings and personal interactions with national leaders, which can lead to increased subsequent clinical consultations, with the community physician becoming a local expert and a second opinion resource, and perhaps garnering a part-time appointment on university faculty.
Dr. Hayes also described several advantages of clinical trials. “Clinical trials give us access to new technologies and new drugs and enable us to remain as cutting-edge as possible. We use clinical trials as a benchmark with algorithms of care—primarily National Comprehensive Cancer Network algorithms—to provide structure within the group…so that there is not too much variation among the physicians in the group. The quality experience is also important; we have better communication with patients through involvement of nurses and mid-level staff.” Thus, he adds, “Clinical trials are a very important strategic center of our practice.”
The workshop faculty provided a host of suggestions for success in conducting clinical trials, focusing primarily on treating clinical trials as a business, hiring adequate staff, and selecting trials. The most important key to success is physician commitment, including the willingness to “commit the staff and time to do it right,” said Peter D. Eisenberg, MD, of California Cancer Care, one of nearly 20 speakers at the workshop.
Dr. Eisenberg commented that physicians “tend to be poor business people with conflicting pressures.” Yet, strong business-like practices are necessary to successfully participate in clinical trials. He noted that physicians should “establish policies and procedures, hire smart, pay well, get colleagues′ buy-in, and keep track of money earned and received.” Dr. Eisenberg added that it is important to know the capabilities of the practice (the patient population, methods of identification, etc.) and to be able to identify patients for study.
Dr. Atkins suggested that attendees ask themselves, “Do you want your operation to be cost neutral or make a profit?” He explained, “You have to know how much it will cost you to be a part of the trials program so that you can reach your goals.” As an example, he noted that a trial that provides payments of $1,500 per patient would result in a cost-neutral situation for a practice, assuming a staff annual salary of $50,000 plus $12,500 in benefits only if 42 patients are enrolled in the trial per year. However, very few physicians enroll 30 to 60 patients per year, with most enrolling five to 10 patients per year. Industry trials usually pay more per patient ($5,000 to $7,000), but more staff time is needed for the increased documentation and oversight that is usually required for such trials.
Dr. Hayes said that the workshop taught him, “No one model of research center economics (NCI protocols, investigator-initiated protocols, or industry-sponsored protocols) has an advantage over another; the important thing is to understand the practice costs involved, to administer the tasks well, and to make good strategic and patient-centered choices.”
An adequate staff committed to clinical research is essential for success. Robert L. Comis, MD, of the CNCCG, who served on the Steering Committee and as faculty for the workshop, talked to attendees about the Elements of Success, a document developed during the Summit Series on Cancer Clinical Trials, in which Dr. Comis participated. According to the Elements of Success, the following staff is needed:
It has been generally recommended that one full-time employee is needed to process 25 to 30 patients enrolled per year onto Cooperative Group trials or 15 to 20 patients onto industry trials. As accruals accumulate over time, another full-time employee may be needed to help manage long-term follow-up of patients.
Presenting a “model of excellence” at the workshop, Marge Good, RN, BSN, MPH, of Wichita CCOP, emphasized that a clinical research nurse and non-nurse clinical research associate support staff are essential for reducing the burden of time for the physician, for maintaining protocol compliance, and for ensuring high-quality data collection. She pointed out that a clinical research nurse can save physician time by assuming several tasks:
With this approach, all parties—physicians, research nurses, and patients—benefit. The time saved for physicians allows them to see more patients and thus increase practice income, nurses are pleased with the autonomy and the contact with patients, and patients are happy with the attention.
Ms. Good also said that it is important for the nurse to “maintain visibility and awareness” by being in the office every day, providing monthly updates to physicians and staff, and conducting regular face-to-face meetings with physicians and staff.
Dr. Comis noted that the financial resources for staff should be adequate to allow the research staff to focus entirely on the research and not be diverted to perform routine clinical or other functions. Resources should also be sufficient to allow (and support) continuing professional education for the staff, including participation in relevant professional societies and regular attendance at national meetings (such as those of ASCO, ONS, and the Cooperative Groups).
According to Dr. Eisenberg, networking plays a large role in finding trials. He suggested calling medical directors, talking with representatives and medical liaisons, and attending the ASCO Annual Meeting as ways to learn about available trials. He added that determining what disease and stage to study is an important step, and that the trial should answer a question the practice wants to answer.
Dr. Tannock told attendees, “Treatments should be applicable to the setting in which you practice—not, for example, a highly specialized technique that might require the resources of a large cancer center.” He discussed important issues in selecting clinical trials and warned about what kinds of trials to avoid. “In general, too many resources are wasted on (often larger) single-arm studies of new treatment strategies that are not done as a precursor of a phase III trial or do not give information about mechanisms,” he said.
Dr. Tannock also recommended caution about trials that ask for a large number of nonstandard investigations and trials in which similar agents are compared. These latter trials, he said, “have little chance of improving patient well-being and are really attempts to support one drug over another with marginal benefit—often when the standard is losing its patent protection.” Some other trials to avoid are those in which neither arm represents standard treatment (unless they are randomized phase II trials where the aim is to decide which of two or more candidate new treatments might be compared with a standard in a subsequent phase III trial) and trials with nonconventional end points (especially those that do not measure patient benefit or that utilize unusual statistical designs). “If a new treatment cannot be shown to be beneficial by conventional means, it probably is not worthwhile.” Lastly, Dr. Tannock warned of trials with unreasonable expectations of benefit. “Advances in cancer treatment almost never lead to absolute changes in overall survival of more than 10%—which will require a trial of about 1,000 patients to detect or exclude,” explained Dr. Tannock. “Smaller trials may detect important differences in symptoms or quality of life.”
Recommendations for selecting trials were also given by Dr. Lyss and Dr. Atkins, the two faculty members representing practices that had received an ASCO Clinical Trials Participation Award. Dr. Lyss said that his practice looks for trials that involve outpatient treatment, phase III regimens, and testing schedules that mimic clinical practice, and eligibility parameters that are not too restrictive. Cooperative Group clinical trials get first priority, he said. Industry trials are used “selectively” to close gaps in the practice's menu of studies and to obtain “hot drugs” in phase II trials, provided that the case report forms are not too labor intensive and the reimbursement is proportional to the amount of data requested by the sponsor.
When asked about how many trials he has open, Dr. Hayes responded with “too many,” adding “We're trying to learn how to be more judicious about opening trials.” Dr. Atkins recommended that when physicians first begin participating in trials, it may be best to focus on three or four protocols in a disease that is common for the practice or that is of particular interest. “Some will pick a few protocols in breast, colon, and lung cancer just to have the big three covered,” he noted. He added that physicians may want to wait until after the first audit to open more trials so that any problems can be solved first. Among Dr. Atkins′ other recommendations were:
Overall, the key is to open only as many trials as staff can manage. “If your staff feels that they are drowning in paperwork you need to slow down in opening new trials and look at the problems to see what can be done to correct them,” said Dr. Atkins.
What affect did the workshop have on Dr. Hayes? “At one time or another, some have tried to persuade us to give up clinical trials and support trials within a medical center or an institutional program,” he said. “That shouldn't happen. Clinical trials are a challenge economically, especially with Medicare reform, but we have to find a way to make it work.” Dr. Hayes is trying to do his part to educate community physicians about clinical trials by planning a presentation for the next meeting of his local oncology society.
Based on the success of the workshop, ASCO is planning to offer it again, October 28 to 30, 2005, in Dallas. Dr. Zon and Dr. Lyss will serve as co-chairs of the Steering Committee, and they are reviewing attendee feedback to further enhance the workshop. Details, including applications for attendance, are available in the Meetings and Education section of the ASCO Web site (www.asco.org). In addition, the 2005 ASCO Annual Meeting, to be held on May 13 to 17, 2005, in Orlando, Florida, will feature a special ASCO/ONS symposium on the elements of a successful clinical trials program. Information about this symposium can also be found on ASCO.org.
Established in 2003, the ASCO Clinical Trials Participation Awards are designed to honor oncology practices that actively participate in clinical trials as a means of enhancing awareness and increasing participation in these endeavors. In 2003, practices were selected by the NCI Cooperative Groups and the ASCO Clinical Practice Committee on the basis of the highest number of accruals over the previous 3 years and the quality of data according to audit results. In 2004, the Cooperative Groups chose high accruers from Community Clinical Oncology Program participants, and the Clinical Practice Committee also chose a high-accruing practice. For 2005, ASCO has asked the Cooperative Groups and the Committee to choose a practice that has made a “special contribution” to clinical trials accrual.
The awards are presented at the ASCO Annual Meeting, and a grant is given to enable a representative from each practice to travel to the meeting. The grants are funded through the Coalition of National Cancer Cooperative Groups.
The program has received positive feedback, with recipients noting that the award is a valued recognition of their participation in clinical trials. In addition, the award has helped recipient practices to conduct significant outreach and public relations in their local communities. ASCO hopes that the award recipients will share their experiences with other community physicians to help them better integrate clinical trials into their practices. Two of the faculty members at the 2004 Clinical Trials Workshop were members of award-winning practices (denoted by an asterisk). An article about the Clinical Trials Participation Award Program, as well as a listing of the 2005 award recipients, will appear in Section B of the Sunday edition of ASCO Daily News, to be distributed onsite at the 2005 ASCO Annual Meeting.