(SALT LAKE CITY)--Investigators at the University of Utah School of Medicine's 数据协调中心 have been awarded a seven-year, $25 million grant from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health, to form one of three Trial Innovation Centers (TIC) to improve clinical research. 的 TICs are part of an initiative to create the Trial Innovation Network as part of the Clinical and Translational Science Award (CTSA目前) Program, which also funds the Center for Clinical & Translational Science (CCTS) at the University of Utah.
J. 迈克尔·迪恩，硕士.D., MBA, professor and vice chairman for research of the 儿科, is the principal investigator for this grant. Jeffrey Botkin， M.D.,英里/小时, associate vice president for research integrity, 儿科学教授, and adjunct professor of human genetics and Internal medicine, 与 凯瑟琳·舍温博士.D., B.N., MSCI, chief, Division of Pediatric Clinical Pharmacology. 杰瑞·伯尔，M.S., RN, will serve as executive director.
"It is a great opportunity for us to participate in the Trial Innovation Network initiative at NCATS. Our central Institutional Review Board (IRB) expertise and extensive experience with multicenter trials have prepared us to be active partners in this initiative,迪恩说. "We are excited to have the opportunity to help realize the potential of the CTSA目前 program as a national laboratory for studying, 理解, and improving multisite translational research."
的 Utah TIC is organized into three areas:
- Support for rapid establishment of single IRB and streamlined contracting for trials initiated in the Trial Innovation Network. Botkin将领导这项工作, in conjunction with the outstanding leadership from our IRB (John Stillman, Ann Johnson) and Office of Sponsored Projects (Brent Brown), 杰瑞·伯尔负责协调. 的 goal is to eliminate a common bottleneck in initiating multicenter trials, and to help investigators comply with the recently published NIH policy requiring a single IRB for all multicenter studies.
- Support for the development and implementation of practical study protocols within feasible budgets. 迪恩将领导这个项目, with experienced leadership from numerous 数据协调中心s in the 儿科 (Marianne Gildea, 安娜·乔利, 莎莉·乔·祖斯潘, Angie Webster and Jeffrey Yearley). 的 goal is early intervention to assist study investigators with study design, delineation of data requirements, preparation of training materials, and efficient implementation of the protocol.
- Support for randomized drug trials, including industry-sponsored trials. 舍温将领导这支队伍, with experienced leaders from the 临床试验 Office (Pavel Kruchek and Jaci Skidmore). 的 goals include assistance with FDA IND and IDE applications, clinical pharmacology and pharmacometric modeling.
的 Utah TIC will collaborate with the TIC at the Duke (University) Clinical 研究 Institute and Vanderbilt University (Principal Investigators: Danny Benjamin and Gordon Bernard), and the TIC at Johns Hopkins Hospital and Tufts University (Principal Investigators: Daniel Hanley and Harry Selker). 的 Trial Innovation Network also includes a Recruitment Innovation Center (RIC) awarded to Vanderbilt University (Principal Investigators: Paul Harris and Consuela Wilkins.) 的 University of 犹他州有条件现金援助项目, led by co-directors Carrie Byington, M.D.威拉德·迪尔，M.D., is also a component of the Vanderbilt RIC program.
About the 数据协调中心
的 University of Utah investigators and staff have extensive experience with coordinating complex multicenter registries, 观察性研究, 随机试验. Over a dozen research networks and 75 studies have been supported over the past decade, including pediatric and adult clinical studies. In conjunction with the 临床试验 Office (CTO) in the 儿科, the 数据协调中心 provides support for multiple external networks as well as clinical trials initiated by investigators at the University of Utah School of Medicine.
About the University of Utah Center for Clinical & Translational Science (CCTS)
的 犹他州有条件现金援助项目 provides the infrastructure for clinical and translational research at the University of Utah. With our partner organizations, 山间医疗, the Utah Department of Health, and the VA Salt Lake City Health Care System, the CCTS supports four Foundations for Discovery including Workforce Development, 精密医学, 人口健康科学, 临床试验支持. 的 临床试验 Support Foundation will work closely with the newly funded TIC to enhance and facilitate the conduct of clinical trials in our region.