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ASCO's workshop Clinical Trials for the Community Oncology Team is resulting in much-needed increases in clinical trial participation at the community practice level. To date, two annual workshops have drawn nearly 100 oncology teams to learn about developing, integrating, and conducting clinical trials. A follow-up survey of attendees of the first workshop demonstrated increased participation in clinical trials according to several key indicators, including the number of participants screened and enrolled, the number of subinvestigators participating, and the total number of open trials.
The workshop, which is developed in collaboration with the Oncology Nursing Society (www.ons.org) and the Coalition of National Cancer Cooperative Groups (www.cancertrialshelp.org), has consistently earned high praise on program evaluations and comments about enhanced knowledge of the practical aspects of conducting clinical trials. Now, the results of the follow-up survey strengthen that positive feedback with a better reflection of the actual behavioral influence of the workshop. “The survey results validate the methodology of the workshop,” says Alan P. Lyss, MD, of the Heartland Cancer Research Community Clinical Oncology Program (CCOP; St. Louis, Missouri), and a co-chair of the 2005 workshop. “The outcomes data show that this program is successful in increasing clinical trial participation by community oncologists and their patients.”
Approximately half of the teams at the 2004 workshop responded to the survey, and the findings represent changes in practice that occurred within the 9 months following the workshop. Lyss and Robin T. Zon, MD, FACP, of Michiana Hematology-Oncology, PC (South Bend, Indiana), also a co-chair of the 2005 Workshop, note that all of the follow-up outcomes are “impressive” (Table 1) and can be related directly to education provided at the workshop. For example, Lyss says, “The workshop includes a session on how to choose trials. The fact that a high number of attendees said that the total number of open trials increased demonstrates that the message of that session got across.”
Of the respondents who said that the number of open trials increased, 75% said the number had increased by as much as 25%. Other promising findings were that 78% of respondents noted increases in the number of patients screened for trials, and 65% reported an increase in the number of patients enrolled. Increases in enrollment of up to 25% were reported by 75% of the respondents who noted an increase; 25% of respondents reported even larger increases.
The number of respondents who indicated that an increased number of participants were remaining on trial and compliant was more modest (35%) than the other increases. “Increases in accrual are paramount to clinical trial research, but ultimately the results are only as good as the strength of the data collected,” says Zon. Nonetheless, both she and Lyss believe that the increase is promising.
The survey also asked participants about their accrual goals for the next 12 months. More than 50% of respondents said their goal was one to 50 participants. “These accrual goals are much more realistic than the goals that we saw on applications,” says Lyss, “so this finding really shows that attendees learned from the workshop.”
Zon notes that care must be taken in interpreting some results because of the diverse backgrounds of the research teams that attended. “We had some teams from CCOPs that were already enrolling 100 or more patients a year, and we had other teams representing very small practices enrolling only a few patients a year,” she says, “but the results are still very encouraging.”
Perhaps the most meaningful survey result is that 71% of respondents said that subinvestigator participation had increased. Zon notes that this finding reflects the “peer pressure” aspect of the workshop. “Attendees are not only getting the take-home message of the workshop, but they are sharing it with their colleagues and they are having a positive influence,” she says.
The workshop was established 2 years ago to meet a goal set forth in the 2004-2007 ASCO Strategic Plan: “promoting high-quality clinical and translational research in oncology, with a focus on patient accrual to clinical trials.” The 2-day workshop is designed to target community oncologists who are currently involved in clinical trials but want to become more efficient and increase their accrual. The workshop provides practical tools that are notcurrently offered in fellowship training programs or continuing educational materials.
Commenting on the need for the workshop, Joseph S. Bailes, MD, ASCO's interim executive vice president and CEO, says, “ASCO remains committed to supporting the educational needs of all oncologists involved in research and recognizes that the community oncologist may face unique issues or barriers to research inherent in their practice setting.”
The workshop focuses on four themes: the role of the oncology team, processes and procedures, resources and reimbursement, and selection of trials. Didactic lectures on these topics are followed by small-group breakout sessions that allow attendees to discuss strategies for effectively employing the techniques presented in the lecture. Feedback from the first workshop helped shape improvements to enhance the learning experience of the 2005 program. At the 2005 workshop, attendees had the opportunity to hear a wider breadth of perspectives through the addition of patient advocates as presenters and moderators and the use of panel discussions. In addition, learning was made more interactive with the availability of mentors during meal breaks.
A distinguishing aspect of the workshop is its emphasis on the team-oriented approach, which is integral to the success of clinical trials in the community practice setting. As such, participants apply for the workshop as a research team—a physician investigator and a research nurse or clinical research associate. The ultimate goal of the workshop is to help increase enrollment of adults on all clinical trials, which has remained at 3% to 5% for several years. Capitalizing on the increasing number of patients with cancer who are treated in the community setting is essential to enhancing enrollment in clinical trials. Increasing access and availability of cancer control and prevention studies at the community level offers additional opportunity for participation in clinical trials.
ASCO plans to continue offering the annual Clinical Trials for the Community Oncology Team workshop, and online applications will be available on May 2, 2006, at www.asco.org/CTW2006 for the 2006 event. “ASCO is committed to fostering clinical research in the community, where the majority of oncology patients receive their treatment,” says ASCO President Sandra J. Horning, MD. “High-quality clinical investigation in all practice settings is essential to the timely development and evaluation of new therapeutics that are vital to patients with cancer.”
“The diversity of the institutions attending, coupled with the similar hurdles we face in community-based research, brought dynamic discussions. One of our key obstacles is the relationship with the local institutional review board. We took notes at the meeting and agreed that dollars would be well spent to improve the relationship. We have since arranged to bring one of the speakers from the ASCO meeting to our local area to speak to both the community researchers and the institutional review board.”
—Lyndon Evans, a research manager at Greenville CCOP, Greenville, South Carolina
“Attending the Clinical Trials Workshop along with my research clinical nurse specialist gave us a deep and thorough understanding of the research process. The workshop had several immediate benefits to our practice
I highly recommend the Clinical Trials Workshop to anyone interested in or currently conducting clinical research. There is room for learning to all.”
—Wael Harb, MD, Horizon Oncology Center, Lafayette, Indiana