Participation in Clinical Trials as a Clinical Trialist for the Community Surgeon
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The definition of a community hospital has been highly variable based on teaching versus non-teaching, proximity to a major metropolitan area, number of hospital beds, governance structure, partnered or not partnered with a larger center, or simply its role as a care hub for the local population. For the purpose of this chapter, the term community hospital will refer to the American Hospital Associations definition as a non-federal, short-term, general, and/or specialty hospitals. This excludes university centers, but includes university affiliates and can be teaching or non-teaching. In 1980, 16% of outpatient surgeries took place at community hospitals. In 2015, this number increased to 66% (National Center for Health Statistics, Center for Disease Control, 2017). Similar trends are being seen in cancer care. Since clinical trials (inclusive of pharmaceutical trials, device trials, quality of life trials, and others) are the means by which the medical and surgical community evaluate and improve care for patients, it is imperative that the population of patients who receive their care at community centers have the opportunity to enroll in clinical trials. Similarly, surgeons in these settings must be armed with the tools needed to participate in clinical trials. This chapter outlines the community surgeon’s involvement in clinical trials. Discussed are the historic perspective (including community participation in practice changing trials), the logistic challenges and barriers in the community hospital, and the unique elements of trials in the community setting compared to the university-based academic settings.
KeywordsCommunity Surgeon NCORP Barriers Trials Personnel
Paul B. Gilman, M.D., Albert DeNittis, M.D., M.S., Jarrod Kauffman, M.D., Alexander Uribe, M.D., John Wellenbach, John H. Marks, M.D.
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