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Data Center Wins $25 Million NIH Grant to Find Ways to Improve Clinical Trials

(SALT LAKE CITY)--Investigators at the University of Utah School of Medicine's Data Coordinating Center 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. The TICs are part of an initiative to create the Trial Innovation Network as part of the Clinical and Translational Science Award (CTSA) Program, which also funds the Center for Clinical & Translational Science (CCTS) at the University of Utah.

J. Michael Dean, M.D., MBA, professor and vice chairman for research of the Department of Pediatrics, is the principal investigator for this grant. Jeffrey Botkin, M.D., MPH, associate vice president for research integrity, professor of pediatrics, and adjunct professor of human genetics and Internal medicine, is a co-Investigator with Catherine Sherwin, Ph.D., B.N., MSCI, chief, Division of Pediatric Clinical Pharmacology. Jeri Burr, 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," Dean said. "We are excited to have the opportunity to help realize the potential of the CTSA program as a national laboratory for studying, understanding, and improving multisite translational research."

The Utah TIC is organized into three areas:

  1. Support for rapid establishment of single IRB and streamlined contracting for trials initiated in the Trial Innovation Network. Botkin will lead this work, in conjunction with the outstanding leadership from our IRB (John Stillman, Ann Johnson) and Office of Sponsored Projects (Brent Brown), coordinated by Jeri Burr. The 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.
  2. Support for the development and implementation of practical study protocols within feasible budgets. Dean will lead this project, with experienced leadership from numerous Data Coordinating Centers in the Department of Pediatrics (Marianne Gildea, Anna Jolley, Sally Jo Zuspan, Angie Webster and Jeffrey Yearley). The 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.
  3. Support for randomized drug trials, including industry-sponsored trials. Sherwin will lead this team, with experienced leaders from the Clinical Trials Office (Pavel Kruchek and Jaci Skidmore). The goals include assistance with FDA IND and IDE applications, clinical pharmacology and pharmacometric modeling.

The Utah TIC will collaborate with the TIC at the Duke (University) Clinical Research 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). The Trial Innovation Network also includes a Recruitment Innovation Center (RIC) awarded to Vanderbilt University (Principal Investigators: Paul Harris and Consuela Wilkins.) The University of Utah CCTS, led by co-directors Carrie Byington, M.D., and Willard Dere, M.D., is also a component of the Vanderbilt RIC program.

About the Data Coordinating Center

The University of Utah investigators and staff have extensive experience with coordinating complex multicenter registries, observational studies, and randomized trials. 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 Clinical Trials Office (CTO) in the Department of Pediatrics, the Data Coordinating Center 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)

The Utah CCTS provides the infrastructure for clinical and translational research at the University of Utah. With our partner organizations, Intermountain Healthcare, the Utah Department of Health, and the VA Salt Lake City Health Care System, the CCTS supports four Foundations for Discovery including Workforce Development, Precision Medicine, Population Health Sciences, and Clinical Trials Support. The Clinical Trials Support Foundation will work closely with the newly funded TIC to enhance and facilitate the conduct of clinical trials in our region.