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1 From the Department of Radiology, Mayo Clinic, 200 First St SW, Rochester, MN 55905. Received January 29, 2006; final version accepted February 2. Supported by the American College of Radiology Imaging Network. Address correspondence to the author (e-mail: subramaniam.rathan{at}mayo.edu).
The specialty of radiology has evolved dramatically with the introduction of ultrasonography, computed tomography, magnetic resonance imaging, and interventional radiology, all of which have proved to be enormously valuable for patient care and have changed the practice of medicine. Yet, success has resulted in a need for evidence-based and hypothesis-driven research to further advance the field of specialty (1).
The Radiological Society of North America (RSNA) sponsored a Clinical Trials Methodology Workshop this year. This inaugural workshop was held January 7–13, 2006, in Phoenix, Ariz, and was modeled after a similar workshop sponsored annually by the American Association of Cancer Research. About 25 participants, including senior residents, fellows, and faculty members, from United States, Canada, and Australia attended the workshop. Workshop faculty members were leading research methodologists and researchers from the United States and the Netherlands. I was delighted and fortunate to attend this intense, extremely rewarding, intellectually stimulating workshop as a current fellow of the American College of Radiology Imaging Network (ACRIN).
The objectives of the workshop were to (a) understand principles of clinical trial design as they apply to studies of imaging technologies for diagnosis and disease monitoring, screening, and image-guided therapy; (b) understand the principles for incorporating imaging as a primary or important secondary end point in therapeutic trials; (c) comprehend the regulatory, funding, and other implementation issues associated with clinical trials in which imaging is used; and (d) develop a clinical trial protocol for the evaluation of an imaging modality or for the use of imaging as an end point in a therapeutic trial.
The workshop was broadly divided into three sections: a didactic program in the mornings, experiential protocol development group meetings in the afternoons, and protocol writing by students and breakout sessions of particular interest in the afternoon or evening. All students also participated in pre- and postworkshop tests.
The goals of the didactic program were to teach the students the basics of clinical research methods, biostatistics, trial organization, data management, and quality assurance and to introduce them to the national clinical research infrastructure available through organizations such as the National Cancer Institute and ACRIN. The subjects covered in the didactic program included general concepts of study design, concepts and methods for assessing accuracy of imaging modalities, imaging as a measure of therapeutic response, principles of image-guided interventional studies, overview of screening studies and modeling for the assessment of screening modalities, evidence-based diagnosis, cost-effectiveness of studies, quality of life, patient satisfaction and heath care utilization outcomes, bias considerations, analysis of receiver operating characteristic curves, design of multireader studies, sponsorship and economics of imaging trials, basic ethics for conducting clinical trials, and Food and Drug Administration and National Cancer Institute regulatory issues. These lectures enabled the students to understand the various facets of developing, conducting, and funding clinical trials in radiology.
The experiential protocol development group meetings allowed the students to develop a research concept into a well-designed clinical research protocol that was almost complete by the end of the workshop. For me, this was the most important, intellectually challenging, intensive, and rewarding component of the workshop.
There were five protocol development groups. Each group had four to five students and four faculty members who were experienced researchers and methodologists. Each student was asked to put forward a study concept before being selected to participate in the program. A primary objective for each study was developed early in the week, during the protocol development meetings. This was followed by intense writing of protocols, with daily feedback and discussion with the faculty and other members of the group. Each student not only had the opportunity to receive feedback and perspectives about his or her study from experienced faculty members but also was able to contribute to the protocol development of other students in the group. As part of their protocol, students developed primary and secondary objectives for the study, study schema, background and importance, study overview, study design, statistical basis for the study, data collection and management, data collection and consent forms, adverse events reporting forms, and image acquisition and archiving protocols. The concentrated mentoring students received from the faculty in developing the protocols was excellent.
The afternoon or evening breakout sessions included research synthesis (meta-analysis), informatics for clinical research, Food and Drug Administration and National Cancer Institute regulatory issues, and cost-effectiveness. These allowed the students to gain a deeper understanding of an area of particular interest. Students also had the opportunity to learn about the national research infrastructure such as ACRIN, which is a National Cancer Institute–funded clinical trials consortium devoted to conducting clinical trials of diagnostic imaging and image-guided therapy as they relate to cancer (2).
What we learned in the workshop was extremely valuable and can be applied for any research project. At a personal level, I immensely enjoyed the challenge of developing an almost complete protocol within a week and the opportunity to associate and network with leading researchers, methodologists, and future research leaders. I have no doubt that what we were exposed to and the network that we established during this workshop will transform our academic careers.
I congratulate RSNA for taking this very important responsibility. I am sure the benefits of this workshop will ripple through the young radiology research community within the next few years. I sincerely hope the RSNA will sponsor this workshop annually, and I thoroughly encourage anyone who is interested in academic radiology to consider attending this workshop if it is offered again.
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  G. J. Becker RSNA Takes Another Step in Support of Imaging Research Radiology, December 1, 2006; 241(3): 653 - 656. [Full Text] [PDF]
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