The ACR Clinical Research Center helps build a National Cancer Clinical Trials System for the 21st century.
In November 2010, the National Cancer Institute (NCI) announced an initiative to restructure its clinical trials cooperative group program. As the rationale, the NCI cited recommendations made by the Institute of Medicine in its consensus report "A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program."1
At that time, NCI conveyed that it would fund only four adult cooperative research groups to participate in its new National Clinical Trials Network (NCTN), a reduction from the nine groups currently funded to carry out multi-center oncologic clinical trials. This consolidation required ACRIN® and RTOG® leadership to pursue options for combining their respective cancer imaging and radiation oncology research programs with one or more of the other seven groups — all of which have extensive infrastructure, hundreds of members, unique organizational cultures, and histories dating back 40 or more years.
Recognizing a need for greater coordination of imaging and radiation oncology quality-assurance (QA) activities within its future network, the NCI also announced a grant opportunity for a single entity to provide QA services for the entire NCTN. The ACR Imaging and Radiation Oncology Core Laboratory is one of many programs that currently provide QA services for NCI clinical trials.
"After recovering from the reality and the enormity of the proposed changes, the ACRIN and RTOG leadership went to work exploring various configurations to identify the best situation for the future of imaging and radiation oncology clinical research," says Steven King, MS, FACE, assistant executive director of the ACR Clinical Research Center. "The ACR also took the lead in bringing together the many groups involved with imaging and radiation oncology QA services to form a single-entity service model."
The timeline to accomplish the transformation was ambitious. Within approximately one year, the existing groups needed to realign their well-established research programs in preparation to respond to the NCI's grant application for NCTN participation, which was released in July 2012. The recently aligned groups had less than six months to create a new organizational structure, build a scientific program based upon the research strengths of each legacy group, and determine how innovation would be infused into the research of the newly formed group. Grant proposals submitted to the NCI by the January 15, 2013, deadlines represented months of intensive work by thousands of individuals around the country involved in the NCI clinical trials research. New research programs emerging from the ACR's Clinical Research Center include ECOG-ACRIN Cancer Research Group, a merger of the Eastern Cooperative Oncology Group (ECOG) and ACRIN's oncology research program; NRG Oncology, an alignment of the RTOG, National Surgical Adjuvant Breast and Bowel Program (NSABP), and the Gynecologic Oncology Group (GOG); and the Imaging Radiation Oncology Core (IROC) Group, which recrafts several organizations that currently provide imaging and radiation oncology QA services independently into a single entity.
This is a year of transition as NCI clinical trial cooperative groups continue to carry out their research programs funded under the existing NCI structure. Meanwhile, in anticipation of NCTN participation, work continues to integrate scientific committees, harmonize organizational processes, and plan for implementing new research strategies for when the grant awards are rolled out, sometime in the first half of 2014.
"I applaud doctors Schnall and Curran and all who contributed to this tremendous effort for their dedication to guiding ACRIN and RTOG through the NCI’s cooperative group program’s transformation, ensuring the best possible outcome for the future of imaging and radiation oncology clinical research." — Jonathan S. Lewin, MD, FACR, Martin Donner Professor and chair of the Russell H. Morgan Department of Radiology and Radiological Science at Johns Hopkins University
ECOG-ACRIN Cancer Research Group
"Scientific opportunity has driven the merger of ACRIN's oncology research program with ECOG," says Mitchell J. Schnall, MD, PhD, chair of the Department of Radiology at the University of Pennsylvania, who co-chairs ECOG-ACRIN Cancer Research Group with Robert Comis, MD, a long-time leader of ECOG and the Coalition of Cancer Cooperative Groups. "From the very beginning, we have been excited about the integration of ACRIN's advanced imaging capabilities and ECOG's strong laboratory sciences program from the potential it offers to translate the understanding of cancer biology into the development of targeted cancer therapies." ECOG-ACRIN plans to leverage its combined expertise to investigate strategies for identifying patients appropriate for targeted cancer therapy, monitoring the effects of treatment, predicting treatment-related toxicity, and identifying cancer recurrence.
Additionally, ECOG-ACRIN intends to build upon ACRIN's clinical trial legacy to include primary oncologic imaging trials to develop and validate new imaging methods for use in clinical trials and subsequently in patient care. More specifically, the planned objectives for ECOG-ACRIN's advanced imaging research include developing and evaluating imaging-based surveillance of populations at high risk of cancer, developing and validating imaging biomarkers to predict and monitor therapy response, and evaluating the effectiveness of imaging-directed therapy on improving patient management and associated outcomes.
Schnall also reports that ECOG-ACRIN investigators are already engaged in several exciting research projects as a result of the groups' collaborating to submit ECOG's Community Cancer Oncology Program (CCOP) Research Base grant renewal under the ECOG-ACRIN program. "It was very generous of ECOG to offer this opportunity early on in our merger discussions," comments Schnall, who reported that the program, funded last spring, has allowed ECOG-ACRIN to jump-start its research collaboration.
Schanll also emphasizes the need for greater clinical research participation of radiologists in both private practice and academic settings. "The ECOG-ACRIN CCOP Research Base will enable us to support new initiatives in screening, cancer prevention, and health outcomes," says Schnall, "but we need more practices to become engaged in clinical research to expedite obtaining trial results to inform health policy and clinical decision making. In the coming months, we will be reaching out to radiologists at institutions historically engaged in ECOG research to invite them to be an important part of the research community."
"NRG Oncology offers the exciting opportunity to create an international leader in clinical and translational research across all the cancer disease sites that the three legacy groups have studied," says RTOG Group Chair Walter J. Curran, MD, executive director of the Winship Cancer Institute of Emory University in Atlanta. The RTOG, NSABP, and GOG bring unique and synergistic scientific expertise to the NRG Oncology's research program that will focus on seven cancer disease sites: brain, head and neck, breast, lung, gastrointestinal, genitourinary, and gynecologic. "In many areas, we are bringing together programs that will create new strengths, and in others we are combining programs that are already independently strong," notes Curran.
Norman Wolmark, MD, NSABP chair, and professor of surgery at Temple University in Philadelphia, and Philip J. DiSaia, MD, GOG chair, and professor and fellowship director of the Division of Gynecologic Oncology in the Department of Obstetrics at the University of California at Irvine, will join Curran serving as NRG Oncology group co-chairs and will share equal responsibility for executing the group's research program. "As a leadership team, we are very determined to continue to create a home for discovery and creativity," emphasizes Curran, who also points out the complimentary components of the three groups' legacy research upon which NRG Oncology will build. This includes RTOG's extensive research in the areas of brain tumors and cancers of the head and neck, lung, prostate, and non-colorectal GI; GOG's international leadership in the conduct of late-phase gynecologic cancer trials and translational research; and NSABP's large-scale breast and colon cancer trials.
Of particular interest to radiation oncologists is NRG Oncology's plan to develop and test innovative advanced radiation oncology technology across the entire NCTN through a newly designed Center for Innovation in Radiation Oncology. Curran states, "This center's capabilities will promote the design and execution of trials that systematically evaluate new radiation oncology approaches to cancer treatment."
Benefitting from the landmark translational science results from the group's legacy committees, another key emphasis of NRG Oncology's trials is the use of biomarkers to stratify patients with potentially curable malignancies to therapeutic regimens that are designed to truly reflect both the risk of tumor recurrence and the risk of therapy-related toxicities. Efforts are currently underway to better understand the biological underpinnings of patient-reported toxicities, to evaluate pathways, and to enhance the mechanisms for interventions.
"If we can run as one organization, we can be extraordinarily successful in defining new and better ways of thinking about the diseases we're studying and in taking care of patients," Curran says.
"Clinical research is an essential pillar of the ACR because what we learn from its endeavors advances the care of our patients. The ACR has proudly supported RTOG and ACRIN’s practice-defining work over the past 40 years, and I have confidence that ECOG-ACRIN and NRG Oncology’s expanded and integrated organizations will continue to achieve exciting scientific discoveries." — Harvey L. Neiman, MD, FACR, CEO of the College
Imaging and Radiation Oncology Core Group
The ACR has long been engaged in the development of IT infrastructure to support NCI-funded ACRIN and RTOG clinical trials. This support has been especially focused on the quality-assurance services provided by the ACR Core Laboratory, such as hardware and software validation, equipment qualification, and quality control for imaging and radiation therapy planning.
Because of this extensive clinical research IT background, the ACR facilitated bringing together the various disparate organizations currently providing quality-assurance services to respond to the NCI grant opportunity. IROC's overarching goal is simple, says David S. Followill, PhD, IROC co-director and principal investigator for radiation oncology, and chief of outreach physics in the Department of Radiation Physics at the University of Texas MD Anderson Cancer Center in Houston: "We are striving to assure quality in clinical trials in an efficient and consistent manner." However, the scope and scale of the project make it a major undertaking. "The formation of the IROC group brings together imaging and radiation therapy quality-assurance centers under one mission," says Followill. "This has never been done in the past 45 years of clinical trial work in the United States."
The IT support needed for IROC will be significant. "The ACR brings a particular expertise to the IT and informatics issues underlying the imaging research workflow," says Mike Tilkin, ACR chief information officer, "and we continue to make advances in infrastructure as well as promote standards and integrated solutions that advance quality and promote efficiency in the use of imaging in research."
IROC co-director and principal investigator for imaging Michael V. Knopp, MD, PhD, professor of radiology, the Novartis Chair of Imaging Research, and the director of the Wright Center of Innovation in Biomedical Imaging at Ohio State University in Columbus, Ohio, points to IROC's potential to enhance the role of imaging and radiation oncology in clinical trials. "The most important aspect of IROC is the opportunity to bring imaging to the forefront in high-quality and appropriate utilization and to help increase its future potential in utilization in clinical trials," he says. These efforts will bring positive results for patients, physicians, and the specialty as a whole. "The more we push this national-level service forward," Knopp continues, "the more we increase the visibility of imaging and radiation oncology. I think we are on a very exciting trajectory of success."
By Nancy Fredericks, MBA
1. Institute of Medicine of the National Academies. “A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.” April 15, 2010.