Invested in Improvement
What motivates ACR clinical research trial volunteers and leaders?
Members of the radiation oncology and radiology communities volunteer countless hours to carry out trials supported by ACR's Clinical Research Center.
According to a recent Institute of Medicine review of the National Cancer Institute's (NCI) Cooperative Group program, "the desire to advance cancer research and improve future patient care, to be involved in the design and conduct of clinical trials, and to offer patients access to state-of-the-art care" motivates these professionals to participate in activities beyond those required by their private practices or academic positions.
Compensation is provided to some investigators for their contributions to the research conducted by the Radiation Therapy Oncology Group (RTOG®), American College of Radiology Imaging Network (ACRIN®), and Quality Research in Radiation Oncology (QRRO™), but these funds don't cover all of the hours devoted to their research. This is especially true for a trial principal investigator (PI) who oversees an entire trial, from development of an initial concept through publication of results.
In addition, investigators, clinical research associates, and a cadre of other specialists who conduct research at a single institution contribute to countless hours beyond what's required. Also, hundreds of clinicians serve on committees that oversee such critical functions as the development and prioritization of research goals, patient advocacy, institutional membership, and the publication of research results.
The value of volunteer work was quantified in data presented at the September 2010 meeting of the NCI's Clinical Trials Advisory Committee. According to the data, PIs chairing scientific and administrative committees and protocols provided 77 percent of their time pro bono or were compensated by their home institutions. The estimate of pro bono work performed across all NCI Clinical Trials Cooperative Groups amounts to $27.7 million annually. This equates to 17 percent of the annual NCI Cooperative Group budget, thus enabling NCI funds to be leveraged for additional value.
Faces of Volunteerism
Why do they choose to volunteer? Michael S. Yu, M.D., FRCPC, from Fox Chase Cancer Center in Philadelphia, is proud of the ACRIN trials he has championed at his institution. "We have done quite well for several ACRIN PET trials because of the support of referring physicians. Fox Chase in number three in patient accrual for the ACRIN 6678 trial in evaluating FDG-PET/CT in non-small-cell lung cancer," he explains. "Despite accrual challenges, we are the second highest accruing site for the ACRIN 6671 trial, which examines FDG-PET/CT in identifying lymph node metastases in cervical and endometrial carcinoma."
Yu also participated in the center's central reader study for ACRIN 6660, which was facilitated by the imaging core laboratory and assessed whole-body MRI in the evaluation of pediatric malignancies. "The most gratifying aspect of this process," he says, "was identifying the image variations between sites and appreciating how different settings and scanners can affect image quality even within the same study." The experience also confirmed his belief that a central reader study should be a component of every imaging clinical trial.
Serving as site PI for ACRIN trials and participating in the Experimental Imaging Science Committee (EISC) have helped Yu build upon his professional expertise and improve the reputation of Fox Chase in the field of cancer imaging. He has also taken advantage of the opportunity to gain experience with new materials or techniques before they become widely available. "Participation in EISC trials enables me to have hands-on experience with new radiotracers early on," explains Yu, who also finds attending ACRIN annual meetings helpful for "obtaining updated trial news, keeping ahead of the game, and preparing for what's coming in the future."
Dedicated Committee Chair
In addition to his position as chair of the radiation oncology department at Henry Ford Hospital in Detroit, Benjamin Movsas, M.D., wears three hats as a volunteer. These include chairing the RTOG Quality of Life Subcommittee, the ACR Appropriateness Criteria® expert panel on radiation oncology-lung, and the QRRO Lung Committee.
The RTOG Quality of Life Subcommittee, as part of its activity, examines the potential disconnect between physician and patient perspectives about research benefits. "In the RTOG 9801 trial of amifostine for patients with lung cancer, physicians found no improvement in radiation-induced esophagitis, yet patients reported some reduced swallowing difficulties," says Movsas. He is excited about the planned expansion of the NCI Common Toxicity Criteria to incorporate patient-reported criteria in the assessment of acute effects of radiation therapy.
"The experience of working with extremely talented and dedicated professionals on new projects with the potential to help patients on a larger scale than the number seen in a private practice is hard to quantify." — Benjamin Movsas, M.D.
Chairing the QRRO Lung Committee enables Movsas to assess how well these national guidelines are being followed in practice. "We are honored to have an oral presentation at ASTRO of on-site survey data confirming that evidence-based approaches previously incorporated into the guidelines have now been applied by the vast majority of radiation oncologists," he adds. A notable example is a significant increase in the use of concurrent chemotherapy and radiation therapy for stage III non-small-cell lung cancer.
Movsas emphasizes that colleagues who serve on committees ultimately receive so much back from their volunteer efforts. "The experience of working with extremely talented individuals on new projects with the potential to help patients on a larger scale than the number seen in a private practice is hard to quantify," he notes.
Seasoned Patient Advocate
Ann F. Kolker, B.A., from Washington, D.C., brings personal and professional experience with ovarian cancer to her role as an ACRIN patient advocate for gynecologic trials. "After stepping down from my leadership role with the Ovarian Cancer Alliance, it seemed a shame for my accumulated knowledge and experience evaluating research from the perspective of the broader patient community to come to a standstill," she explains.
"I also hungered for involvement in research using imaging tools that provide a more complete approach to the disease. It's gratifying to think that a gynecologic cancer trial might run more smoothly, and with fewer detours for patients, as a result of the expertise I provide in this role."
Following the media attention to radiation safety last winter, Kolker believed it was important to address this topic related to ACRIN trials. She raised the issue of study participants' safety concerns with Barbara K. LeStage, M.H.P., chair of the Patient Advocacy Committee, leading to the establishment of a working group on radiation safety related to imaging examinations.
Jeffrey D. Bradley, M.D., associate professor of radiation oncology at the Washington University School of Medicine in St. Louis, has served on RTOG committees since 1999. In January, Bradley was named chair of the RTOG Lung Cancer Committee, which is responsible for all North American clinical trials related to lung cancer with respect to radiation therapy, (e.g., radiation dose, radiation alone, or with chemotherapy).
Bradley believes that serving as trial PI for three completed and published RTOG trials has prepared him for this leadership role. An additional phase-III comparison of standard-dose versus high-dose conformal radiotherapy with concurrent chemotherapy in stage IIIA/IIIB non-small-cell lung cancer (RTOG 0617) is currently ongoing. Bradley says, "Having experienced the process of RTOG trial development almost four times has taught me how protocols developed by the scientific committees obtain approval and progress through the stages from concept, accrual, and reporting results.
Along with the chairs of other NCI-sponsored Cooperative Group lung committees, Bradley also serves on a new Lung Cancer Screening Committee. "Any phase-III or randomized phase-II trial with more than 100 patients must now obtain approval from this committee in order to be activated," explains Bradley.
The ability to have a direct influence on the lung-cancer research that takes place in North America is a personal motivator for Bradley's committee participation. "In effect, any committee member can propose a concept to be developed into a clinical trial," he says. "Despite the amount of demands associated with this level of commitment, it is a meaningful way to contribute to the profession and to improve cancer treatment," he adds.
Professionals who perform many underfunded, or even unfunded, functions necessary to further the clinical research of RTOG, ACRIN, and QRRO are motivated by what they might contribute to the treatment of patients with cancer, as well as what they might receive in terms of professional challenges and opportunities. This dual focus makes volunteerism in clinical research a beneficial proposition for everyone involved.
By Nancy Fredericks and Julie Catagnus
Julie Catagnus is a freelance writer for the ACR Clinical Research Center.