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Special Report |
1 From the Department of Radiology, University of Virginia Health Sciences Center, Box 170, Charlottesville, VA 22908 (B.J.H.); the Center for Statistical Sciences, Brown University, Providence, RI (C.G.); and the Diagnostic Imaging Program, the National Cancer Institute, Bethesda, Md (D.C.S.). Received June 1, 1999; revision requested July 16; revision received August 2; accepted August 5. Address reprint requests to B.J.H.
Index terms: Radiology and radiologists, outcome studies • Radiology and radiologists, research
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Introduction |
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 TOP Introduction HISTORICAL BACKGROUNDGOALS AND OBJECTIVES OF...ORGANIZATION AND OPERATIONS OF...INSTITUTIONAL AND INDIVIDUAL...SCIENTIFIC AGENDAIMPORTANCE OF ACRIN TO...References |
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Past experience has shown the value of consortia and collaborative groups in ensuring that the conduct of clinical trials is broad-based, generalizable, and timely. The American College of Radiology (ACR) Imaging Network (ACRIN) is a newly formed national cooperative group dedicated to performing rigorous, multiinstitutional, interdisciplinary clinical trials of diagnostic imaging and imaging-guided therapeutic technologies. Established in 1999, ACRIN is funded by the National Cancer Institute (NCI) at more than $22 million for a 5-year period running through 2004. ACRIN joins 12 other NCI-sponsored clinical trial cooperative groups, some of which have existed for more than a quarter of a century. These other cooperative groups—such as the Radiation Therapy Oncology Group, the Eastern Cooperative Oncology Group, and the National Surgical Adjuvant Breast and Bowel Project—focus on trials of medical, surgical, and radiation oncology therapeutic modalities. Thus, ACRIN "rounds out" the clinical trials portfolio of the NCI by supplying an important but heretofore missing element.
The formation of ACRIN marks an era of evolution and growth in the clinical evaluation of medical imaging. As detailed later, the scientific agenda of the network reflects and promotes the growing consensus in the imaging community and the broader community that the clinical evaluation of medical imaging needs to move beyond the assessment of the diagnostic performance of modalities and examine the role of imaging and its effect on the entire process and the outcomes of patient care (1,2).
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HISTORICAL BACKGROUND |
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TOPIntroductionHISTORICAL BACKGROUNDGOALS AND OBJECTIVES OF...ORGANIZATION AND OPERATIONS OF...INSTITUTIONAL AND INDIVIDUAL...SCIENTIFIC AGENDAIMPORTANCE OF ACRIN TO...References |
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Although all of the RDOG studies were ultimately conducted by the same Biostatistics and Data Management Core Group, the need for a trial was determined internally at the NCI, and each trial was offered out for competing proposals as a request for applications. Beginning in 1996, the NCI began to consider whether this was the most efficient manner of conducting medical imaging trials or whether there might be another mechanism that would allow for greater flexibility and scope than was possible under the RDOG construct. Robert Wittes, MD, of the NCI, working with David Bragg, MD, then on temporary attachment to the NCI, convened panels of academic radiologists, industry leaders, and representatives of reimbursement agencies to discuss whether an opportunity existed to advance clinical trials in medical imaging. The result was the issuance of a request for application in August 1997. The request for application called for the development of a new type of cooperative group—termed a "network"—that, consistent with the need for timeliness in such a rapidly progressing field of medicine, could respond more flexibly and rapidly than existing NCI-sponsored cooperative groups. There would be no permanent member institutions. Committees would be developed and modified or disbanded as situations demanded. Committee members would be taken on and excused so as to best take advantage of their talents. Collaborators would include such nontraditional participants as payers and industry. The network would more rapidly consider ideas for trials, design protocols that could be implemented and completed quickly, and employ methods that, when appropriate, would elicit information beyond simple efficacy to include health outcomes and cost.
The request for applications required the submission of a pair of linked proposals—one for the headquarters and another for the data management and biostatistical functions. ACRIN responded to compete for the request for application by proposing a tripartite structure: (a) Bruce Hillman, MD, would serve as the principal investigator for the headquarters proposal; he would lead the committee structure that would develop and promote the scientific activity of the network and bear overall responsibility for ACRIN should the proposal be funded. (b) The ACR research offices in Philadelphia, Pa, directed by Thomas Caldwell, MBA, MHSA, would be the headquarters site; its responsibilities would be to serve as the long-term primary image and data repository (database), to help with protocol development, and to handle quality assurance, auditing, informatics, logistics, and financial management functions. The ACR had performed similar functions for the Radiation Therapy Oncology Group for more than 25 years and also managed many of these responsibilities under subcontract for a number of other NCI-funded research efforts, including the RDOG. (c) The biostatistical group at Brown University, Providence, RI, headed by Constantine Gatsonis, PhD, would be the biostatistical and data management center; Dr Gatsonis' proposed responsibilities included being principal investigator for the linked biostatistics and data management proposal, serving as the network statistician, supervising the design and analysis of ACRIN protocols, and supervising data management activities to be carried out at the headquarters at the ACR offices in Philadelphia.
ACRIN was notified that it would be awarded the contract to pursue development of the network in September 1998. Although funding was not finalized until March 1999, ACRIN immediately began to organize the committee structure it promised in its proposal, activated its headquarters and biostatistical offices, and began to pursue its proposed scientific agenda.
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GOALS AND OBJECTIVES OF ACRIN |
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TOPIntroductionHISTORICAL BACKGROUNDGOALS AND OBJECTIVES OF...ORGANIZATION AND OPERATIONS OF...INSTITUTIONAL AND INDIVIDUAL...SCIENTIFIC AGENDAIMPORTANCE OF ACRIN TO...References |
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1. Evaluate innovative emerging methods of diagnostic imaging and imaging-guided treatment that have the potential to improve the survival rates and the quality of life of patients with cancer.
2. Compare established patterns of imaging diagnosis, staging, and palliative or curative imaging-guided treatment with alternative approaches to improve the effectiveness of care for patients with cancer and reduce its costs.
3. Examine diagnostic and therapeutic strategies that combine imaging procedures with each other and with nonimaging technologies to improve the efficiency of cancer detection and treatment.
4. Assess the value of using imaging examinations to detect cancer in high-risk patient populations (eg, cohorts that are candidates for genetic testing).
5. Decrease the anxiety, pain, and morbidity experienced by patients with cancer by hastening the assessment and diffusion of less-invasive, less-morbidity-inducing methods of diagnosis and treatment.
6. Determine the value of imaging in reducing the anxiety of individuals who have symptoms suggestive of cancer but who eventually are found to be free of malignancy.
7. Disseminate information that accurately depicts the capabilities of imaging technologies to help practitioners better differentiate between worthwhile and inappropriate imaging technologies to incorporate into their practices.
8. Through clinical trials, increase the early availability of new, potentially valuable technologies to a broader range of patients, including special populations (eg, women, minorities, and economically disadvantaged patients), and study the effect of using the technologies in these populations.
9. Assess imaging technologies beyond the evaluation of accuracy to include such end points as the effect of imaging examinations on medical diagnosis, treatment, and health care outcomes, including quality of life and health care costs.
10. Develop new methods and improve existing methods for evaluating the effect medical imaging technologies have on patient care.
11. Attract the best scientists and clinicians to participate in ACRIN trials.
12. Provide for the easy entry and exit of collaborating entities and individual researchers into specific trials for which they have expertise, interest, or the potential for accrual of patients that will benefit the network.
13. Define standards of operation for the high-quality use of imaging technology and disseminate these standards throughout the practitioner community.
14. Collaborate with existing cooperative groups to share protocols and patients to make the best use of network resources and speed patient accrual.
15. Collaborate with industry and payers to gain early access to emerging technologies for clinical trials, diffuse the cost of conducting trials, and hasten the diffusion of valuable technologies into clinical practice.
As noted earlier, ACRIN intends to accomplish its objectives by using several strategies that will influence the prioritization of possible ideas for clinical trials, as follows:
1. A focus on the most important malignancies, as determined by their prevalence, associated morbidity and mortality, cost to society, and potential for improvement in health outcomes.
2. Development of an appropriate mix of trials to (a) investigate the most important emerging imaging innovations, as determined by their potential to improve early diagnosis, reduce morbidity and mortality for patients with cancer, and reduce cost; and (b) assess dominant, important current practices that may be outmoded, ineffective, or excessively costly by using established technologies.
3. Evaluation of a variety of end points, depending on the nature and level of acceptance of the technology, that range from accuracy of diagnosis to effects on patients' health and health care costs.
4. Flexible collaboration between a core group of institutions and accomplished researchers who will participate extensively in ACRIN trials and other institutions, entities (including commercial vendors and payers), and researchers who can make important contributions to specific individual trials.
5. Establishment of a flexible organization that is inclusive of everyone who can contribute to accomplishing the goals of ACRIN and procedures so as to hasten the implementation and completion of clinical trials.
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ORGANIZATION AND OPERATIONS OF ACRIN |
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As noted earlier, there are three critical elements to the organization of ACRIN: the headquarters, the Biostatistics and Data Management Center, and the committee structure (Figure, Table). Because ACRIN's committees set the research agenda and generate the research, the committee structure is the essence of the organization. The committees are the direct responsibility of the network chair and, in his absence, the deputy chair. There are seven vice chairs who are responsible for overseeing either the activities of a cluster of committees or specific functions.
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The Methods Committees—including Committees for Design and Analysis, Outcomes and Quality of Life, and Economics and Cost Impact—are composed of geographically diverse teams of outstanding, multidisciplinary investigators who contribute their expertise to the design of protocols and the analysis of trial results. Members of each of these committees are attached to a trial team as the nature and end points of the trial warrant.
The Support Committees include the Special Populations Committee. A commonly voiced concern of the NCI is that underserved and disadvantaged populations are too frequently underrepresented in clinical trials. Consequently, people in these racial and ethnic groups may be less able than others to access new technologies undergoing clinical trials and trial results may not be applicable to these populations. The Special Populations Committee is charged with promoting trials that address the health concerns of these populations and ensuring that there is a representative sample of them included in ACRIN trials. The Medical Specialties Advisory Committee is composed of the medical, surgical, and radiation oncologist representatives from eight other NCI-sponsored cooperative groups. The responsibilities of this committee are to ensure that ACRIN trials are pertinent to the clinical situation being addressed, to advise on quality control issues related to their specialties, and to provide an avenue for collaboration with their own cooperative groups on trials addressing issues of mutual interest. The remaining support committees—Oncologic Pathology, Quality Control, and Physics and Engineering—are charged with ensuring that standards essential to the conduct of rigorous trials are developed and adhered to.
The activities of the organization are further supported by committees with Vice Chairs for Institutional Participants, Basic Sciences and Molecular Technologies, Industry and Insurers, and Media and Publications. The Institutional Participants Committee sets rules governing the criteria by which institutions can contribute to ACRIN trials. Considerations include personnel, equipment, and compliance with regulatory requirements. In this regard, ACRIN is governed by a set of general standards that apply to all participating institutions; however, there also are trial-specific standards developed by the trial team for each protocol. The Committee on Basic Sciences and Molecular Technologies is charged with surveilling developing technologies that may be future candidates for ACRIN trials and, when possible, incorporating basic science questions into clinical trials. The Committee for Industry and Insurers recruits the participation of these constituencies into ACRIN trials and disseminates information to industry and insurers germane to their interests. The Media and Publications Committee provides internal critical review of manuscripts in preparation for their submission and sets general guidelines for authorship. Publication, however, is ultimately the responsibility of the trial team. The Media and Publications Committee is also responsible for managing the ACRIN Web site (www.acrin .org) and for handling other media relations as needed.
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INSTITUTIONAL AND INDIVIDUAL PARTICIPATION IN ACRIN ACTIVITIES |
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All individuals interested in medical imaging are welcome at the network's semiannual meetings. The first network meeting was held in March 1999, and the second took place in October 1999. Meeting dates through the year 2000 are posted on the Web site. ACRIN meeting programs consist of a mixture of policy making, research agenda–setting, trial development, and educational programs about the conduct of clinical trials. There is no registration fee.
All individuals are also welcome to submit ideas for clinical trials for ACRIN consideration. The process of submitting an idea to ACRIN is detailed on the Web site. Briefly, trial concepts are submitted electronically over the World Wide Web to ACRIN headquarters as summary protocols, which are five- to 10-page documents that include the title, proposed investigators, objectives, background and rationale, methods, analysis, and expected outcomes of the research. Summary protocols are distributed to the relevant disease site and modality committees, which initially evaluate and prioritize the summary protocol according to its importance. The Steering Committee reviews the judgments of the Scientific Committee and determines whether the summary protocol has sufficient promise to be passed on to the Design and Analysis Committee for further development, estimation of needed sample size, and estimation of an approximate budget. The expanded protocol is then reviewed by the Research Strategy Committee (composed of all ACRIN committee chairs), which determines its final priority in ACRIN's scientific agenda. The Executive Committee, composed of the network leadership, determines if there is sufficient funding available for highly prioritized protocols and approves projects for full protocol development, submission for NCI approval, and implementation. It is expected that the entire submission and/or approval process will take no more than 3 months.
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SCIENTIFIC AGENDA |
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TOPIntroductionHISTORICAL BACKGROUNDGOALS AND OBJECTIVES OF...ORGANIZATION AND OPERATIONS OF...INSTITUTIONAL AND INDIVIDUAL...SCIENTIFIC AGENDAIMPORTANCE OF ACRIN TO...References |
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ACRIN's initial protocol is titled "Role of Radiology in the Pretreatment Evaluation of Cervical Carcinoma." The trial team, headed by Hedvig Hricak, MD, PhD, chair of ACRIN's Gynecology Committee, and including an interdisciplinary group of radiologists, gynecologic surgeons, and methodologists, has initially recruited 18 institutions to investigate whether the routine application of CT or MR imaging can improve on traditional International Federation of Gynecology and Obstetrics clinical staging criteria to determine which patients are candidates for surgical intervention. The trial team responded to comments suggesting modifications to the protocol offered by both the NCI and the Gynecologic Oncology Group, which is collaborating on the study. The protocol has been resubmitted to the NCI for final approval. ACRIN hopes to begin recruiting patients during the fall of 1999, conclude recruitment within 12 months, and begin analysis of the data shortly thereafter.
At the first ACRIN meeting in March 1999, the Research Strategy Committee proposed going forward with additional trials. ACRIN has agreed to collaborate on a substudy of a trial to be initiated by the Southwest Oncology Group involving PET in patients with non–small cell lung cancer. Under the guidance of Dr Gatsonis, the trial will evaluate the efficacy of PET for quantitating the response of tumors to systemic treatment and predicting patient survival. This protocol will soon be submitted to the NCI for approval.
The Research Strategy Committee also approved moving forward with a trial evaluating the efficacy of virtual CT colonography. A colonography working group meeting at the ACRIN meeting determined that a sufficient number of patients with tumors have been treated at institutions interested in participating in an ACRIN trial so that a retrospective phase II evaluation is feasible. This trial, headed by C. Daniel Johnson, MD, will seek to define optimal techniques for performing and interpreting colonography, preparatory to a much larger phase III screening trial that ACRIN might conduct in the future. The Research Strategy Committee also agreed to move forward in developing a protocol (Principal Investigator, Denise Aberle, MD) that would evaluate a regimen of sputum biomarkers and spiral CT scanning for screening for lung cancer in a selected population and one that would assess whether digital mammography is superior to conventional screen-film mammography in the screening for breast cancer (Principal Investigator, Etta Pisano, MD). Both of these protocols are now in development. Recently, the Steering Committee, which is responsible for decision making during intervals between semiannual meetings, approved ACRIN's development of a clinical trial proposed by Michael Soulen, MD, to compare chemoembolization and conventional chemotherapy in the treatment of colonic metastases to the liver.
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IMPORTANCE OF ACRIN TO RADIOLOGY |
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Beyond this ultimate goal, practicing radiologists should view ACRIN activities as essential to the continued well-being of their practices. Because of its high media profile and high capital and operating costs, medical imaging has drawn special attention from payers and policymakers concerning the scarcity of scientifically valid information about its appropriate use. In particular, these agencies wish to know more than is currently available about how imaging technology positively affects patients' health and medical costs. ACRIN promises to develop scientifically valid information that can be used to guide (a) practitioners in referring their patients for imaging; (b) medical imaging physicians in how to most appropriately and efficiently use imaging technologies to the benefit of their patients; (c) industry and academic centers on how to more efficiently develop, then advance, new technology; and (d) payers and regulatory agencies concerning reimbursement and policy making as it relates to medical imaging.
In addition, once the initial trial results are published, the data from ACRIN trials will be available to other investigators for secondary analyses. ACRIN will establish credentialling standards for researchers wishing to access ACRIN data.
These are extremely important functions. Large clinical trials are necessarily a collaborative effort. It is essential that imaging scientists and clinicians develop a sense of identity as participants in this collective work. ACRIN can be considered a success if it is able to coalesce the efforts of community and academic radiologists, vendors, and payers to conduct a sequence of successful trials, broadly disseminate the results of these trials so as to affect clinical practice and its reimbursement, and achieve renewal of its NCI funding.
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Footnotes |
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Drs Hillman and Gatsonis receive salary support through the grant funding of ACRIN. Dr Sullivan is employed by the National Cancer Institute, the sponsor of ACRIN.
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References |
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TOPIntroductionHISTORICAL BACKGROUNDGOALS AND OBJECTIVES OF...ORGANIZATION AND OPERATIONS OF...INSTITUTIONAL AND INDIVIDUAL...SCIENTIFIC AGENDAIMPORTANCE OF ACRIN TO...References |
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