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Charting a new course

The NIH is changing the way medical research is funded … and the U is taking action

Jasjit S. Ahluwalia, M.D., is reviewing documents in the Academic Health Center’s Office of Clinical Research when one of his assistants places three Dole 6-oz. fruit snacks on the conference table beside him.

When he sees the containers of cubed fruit floating in syrup, his face lights up, and he proceeds to remove the plastic seal on each tub and consume its contents.

“Those are good!” he exclaims when he’s finished. “They’re not too sweet, and they keep me going.”

Even though Ahluwalia has plenty of energy, he can still use the boost. Hired only last September to head the new Office of Clinical Research — created in response to the AHC’s Clinical Research Task Force report issued two years earlier — he had barely arrived at the University and begun assembling a staff when a bombshell erupted in the pages of the New England Journal of Medicine.

In the October 13, 2005, issue of that venerable journal, Elias Zerhouni, M.D., director of the National Institutes of Health (NIH), announced a new program that is likely to change the way medical research is funded in this country. It’s called the Clinical and Translational Science Awards (CTSA).

This fall, the NIH will grant seven of these awards to help institutions forge new approaches to clinical and translational research — the kind that move medical breakthroughs from the lab to the doctor’s office. These new approaches include training, community-based research, and the creation of centers like the University’s Office of Clinical Research.

In addition, $11.5 million will be allocated for planning grants to help institutions not yet ready to make full applications. By 2012 the NIH will award up to 60 active CTSAs with a total value of about $500 million per year.

Jasjit Ahluwalia, M.D., heads the new Office of Clinical Research, which is guiding the Academic Health Center in its goals to improve and expand its basic and clinical research initiatives.

When the University decided to apply for one of the new grants, it fell to Ahluwalia to coordinate the effort. Unfortunately, the deadline — including extensive documentation of current levels of research infrastructure and spending — allowed just five months to prepare. Fortunately, according to Ahluwalia, the Academic Health Center (AHC) already had a leg up.

“Creating the Office of Clinical Research put us ahead of the curve on this,” he explains. “There are very few academic health centers in the country that can be credited with that kind of foresight. The AHC was visionary in predicting how the field had to move and where the NIH was going.”

The CTSA program is the product of two interdependent causes. One is strategic: A recent NIH study concluded that the advancement of clinical medical research has been neglected. The study’s authors suggested that a grant program would help institutions create a home for clinical research and its principal investigators.

The other cause is economic: The NIH is facing a slight decline in its federal appropriation this year and will continue to do so well into the future. Coupled with inflation, that decline will mean a growing shortfall between research needs and federal money available to fund those needs.

“The NIH budget has undergone a 0.03 percent decrease in funding this year in real dollars,” points out Charles Moldow, M.D., the Medical School’s associate dean of research. And things aren’t going to get better any time soon, he says. As part of the dwindling discretionary portion of the federal budget, the NIH will continue to face constraints in the years to come.

For institutions like the University of Minnesota, the implications are critical. Of America’s 125 medical schools, about 80 currently receive NIH funding for General Clinical Research Centers, also known as GCRCs. (The University houses one such center.) Under the new NIH approach, all GCRCs are being phased out. Other NIH grants like the one known as K12 — which the University is using to underwrite 22 clinical research scholars — will be folded into the CTSA program. If 60 CTSA grants are awarded in 2012, that will leave at least 20 U.S. medical schools that now receive NIH funding on the outside looking in.

“Some of the country’s 125 medical schools aren’t eligible for NIH research money anyway because their primary mission is teaching, not research,” Moldow observes. “But many that are eligible won’t receive grants. There will definitely be winners and losers.”

Which makes the University’s rapid response to the NIH’s new clinical research initiatives even more critical.

“This is not a tweaking,” says Ahluwalia. “This is a major change. The creation of the Office of Clinical Research is just a beginning. We’re fostering a comprehensive approach toward clinical and translational research that reaches across the Academic Health Center’s six schools and colleges.”

The Office of Clinical Research will help recruit and hire new faculty and researchers and, in Ahluwalia’s words, “become an academic home for clinical and translational research.” The office will also coordinate relationships with community-based clinical partners—the hospitals and medical practices where translational research will be implemented and that, in turn, become an invaluable source of feedback on how new treatments and practices actually affect patient care.

The grant application the University filed in March requests funding equivalent to the K12 grants and the General Clinical Research Center grants, plus an additional $6 million to expand the AHC’s clinical and translational research efforts. It adds up to a total of $66.2 million over the five years of the grant.

While University leaders are hopeful, they realize that they’re competing against CTSA proposals from dozens of other elite institutions. Just seven will receive funding in the first year.

What this money — and the formation of the Office of Clinical Research — will mean for medical and health researchers at the University, says Ahluwalia,is that “they will be able to pick up a phone and dial a number and get a live person on the other end of the line who will direct them to people and resources — from biostatistics to regulatory assistance to patient interaction. And if they get hired and don’t have funding for their own research, this will enable them to apply for pilot funding.”

The Office of Clinical Research will also play a direct role in training by funding up to 7 clinical research scholars a year — or 22 over the next three years if the University is awarded a CTSA. The funding will provide faculty with sponsored time of up to three years to do research under the mentorship of a University faculty member.

“The backbone of this grant,” Ahluwalia says, “will be training and education.”

“It’s clear that institutions that are great in clinical care are also great in research and in medical education,” he says. “There is a strong correlation between these three things. If you want to improve education, you must work directly on that, as we are doing right now in the Medical School and throughout the Academic Health Center — but you must also build new partnerships across the state and improve your research enterprise.” 

By Richard Broderick

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