FOR IMMEDIATE RELEASE

Newswise — Investigators at the Johns Hopkins University School of Medicine’s Brain Injury Outcomes program and the Institute for Clinical and Translational Research have been awarded a seven-year, $25 million grant from the National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) to form, along with Tufts University School of Medicine, one of three Trial Innovation Centers.

The goal of the centers is to promote innovations in the efficiency and quality of NIH-funded trials. The centers are part of the NCATS Trial Innovation Network and will work with the national Clinical and Translational Science Program, which funds a consortium of 64 medical research institutions in 31 states and the District of Columbia. The centers will help the institutions form a long-standing infrastructure for multicenter studies to be funded by NIH and other funding agencies.

Daniel F. Hanley, M.D., the Jeffrey and Harriet Legum Professor of Acute Neurological Medicine and director of Brain Injury Outcomes program at the Johns Hopkins University School of Medicine, is the principal investigator for the grant. Daniel Ford, M.D., M.P.H., the David M. Levine Professor and vice dean for clinical investigation at the Johns Hopkins University School of Medicine, is a co-principal investigator, as is Harry P. Selker, executive director of the Institute for Clinical Research and Health Policy Studies and dean of the Clinical and Translational Science Institute at the Tufts University School of Medicine. Karen Lane, an assistant professor of neurology at Johns Hopkins and a co-investigator, will serve as executive director. Megan Kasimatis Singleton, J.D., M.B.E., assistant dean for human research protection and director of the Office of Human Subjects Research at Johns Hopkins, will coordinate single Institutional Review Board activities supported by the grant.

“The Brain Injury Outcomes program has matured in multicenter trials expertise in the 20 years preceding this substantial award, making us a perfect match for this initiative,” Hanley says. “We are already working tirelessly with our partners at the University of Utah Trial Innovation Center and with the paired Duke University Clinical Research Institute-Vanderbilt University Trial Innovation Center, harmonizing ourselves in preparation for the work ahead. We are fortunate to have such venerable colleagues in the network and throughout the entire consortium.”

Aims of the Johns Hopkins University-Tufts Trial Innovation Center include constructing a fully operational single Institutional Review Board and institutional master agreements within six months of the award; creating a multidisciplinary, multistakeholder infrastructure and processes that infuse innovations into future trials; and disseminating innovations to research trainees and trial education venues. Trials for Alzheimer’s disease and aging are among several domains that the Johns Hopkins University-Tufts Trial Innovation Center will focus on developing.

About BIOS

The Brain Injury Outcomes program has maintained a high level of neuroscience research activity, with substantial funding from a variety of studies sponsored by, among others, the Food and Drug Administration’s Office of Orphan Products Development (rare diseases); the National Heart, Lung, and Blood Institute; the National Institute of Neurological Disorders and Stroke; the National Institute of Allergy and Infectious Diseases; and the Department of Veterans Affairs. The Brain Injury Outcomes Division has extensive experience in the design, oversight and analyses of neurological and neurosurgical clinical trials, whether conducted by investigators within the Johns Hopkins University system or through various national and international consortia. The BIOS faculty and staff will work closely on the newly funded Trial Innovation Center projects.

About the Institute for Clinical and Translational Research

The Institute for Clinical and Translational Research is the Johns Hopkins University School of Medicine’s clinical and translational science program. Established in 2007, it is one of the 64 medical research institutions working together as a national consortium to improve the way biomedical research is conducted across the country. The institute addresses obstacles in translating basic science discoveries into research in humans, translating clinical discoveries into the community and communicating experience from clinical practice back to researchers. Daniel Ford serves as the director of the institute. Mark Garcia, the institute’s administrator, is a co-investigator for the Trial Innovation Network.