The University of Michigan Health System has received a $33.6 million grantone of the largest of its kind in the nationfrom the National Institutes of Health (NIH) to fund its General Clinical Research Center for five more years starting this month.
The award will allow the Health System 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 NIHs 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-Ms Center. A companion NIH grant will support half the cost of a $1.2 million renovation and expansion, with the other half coming from the Health System in an expenditure approved by the Regents March 15.
The U-Ms Center is among the oldest and largest in the nations 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 Health System CEO Gilbert S. Omenn, principal investigator on the Center grant.
Academic medical centers such as ours generate many new medical discoveries, and our Center 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, the Center program director, This award will provide the Center with additional resources to better assist the Universitys life scientists in translating their laboratory findings into new clinical knowledge and innovative therapeutics.
Wiley and Dorene Markel, the Centers administrative director, oversee the Centers activities and 63 staff members. More than 580 researchers are involved with studies at the Center, 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 Center grant, the NIH will fund a new Research Subjects Ombudsman based at the Center to oversee patient safety issues and related investigator training.
The Center provides specialized inpatient space, located on the seventh floor of University Hospital and staffed by skilled nurses and physician assistants. The Center includes 16 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 move to the nearby Med Inn Building.
The grant also will pay for specialized cell-sorting equipment for the Centers Human Applications Laboratory, where research on gene therapy and immunotherapy agents takes place under the direction of Blake Roessler.
And the funding will help purchase state-of-the-art medical imaging equipment for a new core facility that will allow the Center researchers and others at the Health System to study new ways to see the bodys inner workings. The Biomedical Imaging Core is led by Kirk Frey.
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, Center 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 fund 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 Centers 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 Center 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.
General Clinical Research Center Featured Projects
The General Clinical Research Center at the Health System is home to more than 200 clinical trials each year. The following list of continuing and new projects that will be supported by the new $33.6 million grant exemplifies the broad range of research investigation at the Center.