The emergence of the American College of Radiology Imaging Network (ACRIN) as a premier vehicle for clinical trials involving medical imaging and the growth of imaging itself in clinical decision-making are not a coincidence. Medical imaging increasingly finds itself at the point of randomization in clinical trials, as evidence is demanded of its true value in influencing health outcomes. As a cooperative group founded by the National Cancer Institute in 1999, ACRIN now boasts of dissemination of $100 million toward clinical trials .
The machinery for randomized controlled trials (RCT) comprises a multidisciplinary and multiinstitutional team. One of the most important cogs of this apparatus is the clinical research coordinator (CRC). The CRC is an important complement to the principal investigator in managing various aspects of clinical research.
The center stage occupied by ACRIN in imaging-related clinical research and the importance of CRCs in conducting this work have conflated to create a committee that takes a proactive approach with the provision of education, training, and mentoring of CRCs: the ACRIN Research Associate Committee. This committee has endeavored to study the characteristics of the CRCs who are in any way involved in ACRIN-based activities in order to improve quality of research and better inform hiring decisions by institutes participating in clinical trials. The results of their timely survey are presented in the current issue of this journal .
The diverse activities of the CRC in turn entail a broad skill set, while continuously requiring quality and uniformity. The need for uniformity deserves further emphasis. The generalizability of the results of RCT is, in a large part, determined by strict adherence to protocol by multiple investigators at disparate institutes across many different health systems or even countries. Local practices do vary, but there is some convergence of values stipulated by the institutional review board in the subject of human experimentation. Uniformity of practice dictates that there should ideally be uniformity of training or, in the very least, a common pathway that is available to those involved in clinical research.
There are options available to CRCs to demonstrate proficiency in human subject research and data management, although none of them is specific to research involving medical imaging. The survey showed that only 31% of CRCs have such certifications. Fewer than 40% of those surveyed believe that any certification is a necessity. The authors rightly conclude that these perceptions are at odds with employer expectations. Given that the level of federal oversight is unlikely to diminish in the future because of the emphasis on evidence-based policy generation, the requirement for certification is likely to be even more stringent and could be independent of the experience of the CRC. In fact, CRCs who possessed a certificate or a higher degree were more likely to earn a higher salary.
The survey shows that CRCs are indeed an integral part of the research team. Many have emerged from vocations that are integral or allied to health care delivery. There is a large variation in the jobs in addition to research coordination that CRCs perform, with differing expectations of supervisory oversight. That CRCs are not a monolith may make homogeneous pathway for their recruitment more challenging, although once recruited they may be asked to demonstrate a similar level of competency.
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References
1. American College of Radiology Imaging Network. Available at: http://www.acrin.org . Accessed September 08, 2010.
2. Smith W., Salenius S., Cobb C., Marzan R., Sabina S., Beccaria L., et. al.: A survey of clinical research coordinators in the cooperative group setting of the American College of Radiology Imaging Network (ACRIN). Acad Radiol 2010; 17: pp. 1449-1454.