Developing a clinical trial unit to advance research in an academic institution

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• 作者：Ivana T. Croghan^a ; ^{croghan.ivana@mayo.edu" class="auth_mail" title="E-mail the corresponding author} ; Steven D. Viker^a ; ^{viker.steven@mayo.edu" class="auth_mail" title="E-mail the corresponding author} ; Andrew H. Limper^a ; ^{limper.andrew@mayo.edu" class="auth_mail" title="E-mail the corresponding author} ; Tamara K. Evans^a ; ^{evans.tamara@mayo.edu" class="auth_mail" title="E-mail the corresponding author} ; Alissa R. Cornell^b ; ^{cornell.alissa@mayo.edu" class="auth_mail" title="E-mail the corresponding author} ; Jon O. Ebbert^a ; ^{ebbert.jon@mayo.edu" class="auth_mail" title="E-mail the corresponding author} ; Morie A. Gertz^a ; ^{gertz.morie@mayo.edu" class="auth_mail" title="E-mail the corresponding author}
• 关键词：AAHC ; Association of Academic Health Centers ; CRO ; Clinical Research Office ; CTSA ; Clinical and Translational Science Awards ; CTU ; clinical trial unit ; DOM ; Department of Medicine ; FDA ; Food and Drug Administration ; GCP ; Good Clinical Practice ; IMARC ; Information Management and Reporting Center ; NIH ; National Institutes of Health ; PI ; principal investigator ; SCs ; study coordinators
• 刊名：Contemporary Clinical Trials
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：45
• 期：part_PB
• 页码：270-276
• 全文大小：570 K

文摘

Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trial unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine clinical trial unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a central unit to provide research support in clinical trials and presents the advantages, disadvantages, and required building blocks for such a unit.