title: Developing a clinical trial unit to advance research in an academic institution.
abstract: 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.
authors.affiliation: Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: croghan.ivana@mayo.edu.
authors.forename: Ivana T
authors.initials: IT
authors.lastname: Croghan
authors.affiliation: Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: viker.steven@mayo.edu.
authors.forename: Steven D
authors.initials: SD
authors.lastname: Viker
authors.affiliation: Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: limper.andrew@mayo.edu.
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Limper
authors.affiliation: Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: evans.tamara@mayo.edu.
authors.forename: Tamara K
authors.initials: TK
authors.lastname: Evans
authors.affiliation: Department of System and Procedures, Research and Education Unit, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: cornell.alissa@mayo.edu.
authors.forename: Alissa R
authors.initials: AR
authors.lastname: Cornell
authors.affiliation: Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: ebbert.jon@mayo.edu.
authors.forename: Jon O
authors.initials: JO
authors.lastname: Ebbert
authors.affiliation: Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: gertz.morie@mayo.edu.
authors.forename: Morie A
authors.initials: MA
authors.lastname: Gertz
mesh_terms: D000046:Academic Medical Centers / Q000191:economics / Q000458:organization & administration*; D035843:Biomedical Research / Q000191:economics / Q000458:organization & administration*; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods; D003365:Costs and Cost Analysis; D006801:Humans; D008611:Mentors
keywords: Clinical trial unit; Mentorship; Protocol development; Research coordinator; Research staff; Trial management