From University of Michigan Health System
U-M Health System receives $33.6 million grant for clinical research program
Over 2,200 patients and volunteers each year take part in advanced clinical research at center
ANN ARBOR, MI - The University of Michigan Health System has won a $33.6 million grant - one of the largest of its kind in the nation - from the National Institutes of Health to fund its General Clinical Research Center for five more years starting this month.
The award will allow UMHS to continue and strengthen its long tradition of providing a home for cutting-edge clinical research that gives patients access to the latest advances and helps increase knowledge about disease and the human body.
Given by NIH's National Center for Research Resources in a rigorous competition, the grant funds specialized facilities, staff and resources that support more than 200 clinical studies at any given time. It is the largest grant in the 38-year history of the U-M's center. A companion NIH grant will support half the cost of a $1.2-million renovation and expansion, with the other half coming from UMHS in an expenditure expected to be approved by the U-M Regents this Thursday.
The U-M's GCRC is among the oldest and largest in the nation's system of 77 such centers, and the only one in Michigan. More than 2,200 adult and pediatric patients come to the center each year to participate in studies of medical conditions and trials of innovative therapies for everything from cancer and heart disease to sleep disorders and rare metabolic syndromes.
"Every new therapy that reaches the general public today gets there only through multiple steps of clinical research. That research needs a special environment to thrive," says UMHS CEO Gilbert S. Omenn, M.D., Ph.D., principal investigator on the GCRC grant. "Academic medical centers such as ours generate many new medical discoveries, and our GCRC provides U-M researchers the space and expertise needed for a comparative advantage in NIH- and corporate-sponsored clinical studies in patients and volunteer participants."
Adds John Wiley, M.D., GCRC program director, "This award will provide the GCRC with additional resources to better assist the University's life scientists in translating their laboratory findings into new clinical knowledge and innovative therapeutics."
Wiley and Dorene Markel, M.S., M.H.S.A., the GCRC's administrative director, oversee the center's activities and 63 staff members. More than 580 researchers are involved with studies at the GCRC, performing research funded by the NIH, other federal agencies and industry.
All research is overseen by an advisory board and strictly adheres to federal guidelines for studies involving humans. In addition to the main GCRC grant, the NIH will now fund a new Research Subjects Ombudsman based at the U-M GCRC to oversee patient safety issues and related investigator training.
The GCRC provides specialized inpatient space, located on the seventh floor of University Hospital and staffed by skilled nurses and physician assistants. The Center includes sixteen inpatient beds, where study participants spend more than 3,200 nights a year. Its Metabolic Kitchen and bionutritional staff provide carefully made meals, while an on-site laboratory allows blood and other samples to be collected and analyzed. The center also provides crucial biostatistical and informatics support to researchers.
Its outpatient clinic, which logs more than 4,000 visits a year, is now located next to the inpatient space, but will now move to the nearby Med Inn Building thanks to the new grant.
The new center grant will pay for specialized cell-sorting equipment for the GCRC's Human Applications Laboratory, where research on gene therapy and immunotherapy agents, including "cancer vaccines", takes place under the direction of Blake Roessler, M.D.
And, the funding will help purchase state-of-the-art medical imaging equipment for a new core facility that will allow GCRC researchers and others at UMHS to study new ways to see the body's inner workings. The new Biomedical Imaging Core is led by Kirk Frey, M.D., Ph.D.
The bulk of the main grant provides core funding for more than 200 clinical studies performed at the center. Specific project grants, given separately, add another $97 million.
This research addresses dozens of medical conditions and phenomena. For example, GCRC investigators are currently working to understand or find new treatment strategies for cardiovascular disease; cancers of the lung, breast, liver, lymph nodes, nerve cells, pancreas and skin; diabetes and other hormonal disorders; depression; fibromyalgia; menopause; high blood pressure; thyroid disease; psoriasis; rheumatoid arthritis; childhood cancers; and lupus.
The smaller grant for renovation and expansion will go towards the remodeling of the inpatient space, including the dedication of two rooms to sleep research that can track the effects of both diseases and medical interventions on sleep patterns.
The construction funds also will allow the GCRC's outpatient facilities to move from the hospital floor to the nearby Med Inn Building, increasing convenience for trial participants whose appointments take less than a day, and returning inpatient space to hospital use. The new outpatient space will feature the same number of exam rooms and infusion rooms that the current outpatient GCRC has, as well as a small specimen lab and satellite bionutrition unit. The emphasis on outpatient visits reflects a growing trend in clinical trial design and medicine in general.