Southern research alliance could serve as model for NIH roadmap

Clinical trials could be brought to underserved populations

When NIH announced in late 2003 that it was rolling out the NIH Roadmap for Medical Research, there were no specific examples to show how this ambitious initiative might work in the real world.

Soon, major research and medical institutions in South Carolina may have a working model for the successful implementation of the roadmap’s main objectives. The state’s two largest medical research universities, the Medical University of South Carolina (MUSC) in Charleston and the University of South Carolina (USC) in Columbia, have joined forces with two of the largest health care providers, Palmetto Health of Columbia and the Greenville Hospital System (GHS), to form a research collaboration called Health Sciences South Carolina.

With a commitment to jointly invest $80 million in health sciences research over the next decade, the collaboration will concentrate greater clinical research power in the state, drawing attention to institutions that otherwise might be overlooked by sponsors and grants.

While Health Sciences South Carolina wasn’t planned because of the NIH roadmap, it’s very in line with the objectives the NIH roadmap advocates, says Raymond S. Greenberg, MD, PhD, president of MUSC.

"We have met with the most senior people in the extramural grant program at NIH to talk about integration of research operations," Greenberg says. "They said this is consistent with what they have been advocating in terms of aspects of the roadmap and interdisciplinary work."

Reaching the community

One of the NIH roadmap’s chief objectives is to expand research to the community where it is easier to recruit subjects and where research benefits might be realized more easily.

The South Carolina initiative has a goal to do exactly that by providing education about research and additional resources to small and rural health clinics where there are many patients who could benefit from participation in clinical studies.

More than one-third of the state’s population is African American, and its rural areas have an even higher percentage of minorities who would have an opportunity to enroll in research projects offered through the collaboration.

Also, the rural populations could benefit from having health science research brought to their communities, Greenberg and the other collaboration leaders say.

In South Carolina’s three medium-sized urban areas, where the institutions all are based, residents have about the same access to clinical trials that they would in most medium-sized U.S. cities, says Harris Pastides, PhD, vice president for research and health sciences at USC.

However, more than half of South Carolina’s population is in small towns and rural areas where health care equity is an issue, he notes.

"Health Sciences South Carolina is an opportunity for us to focus on health care and medical issues and therapeutic issues that affect poor and rural and African American people," Pastides says. "This collaboration will make it easier to access patients, provide experimental research and, hopefully down the road, provide higher quality medical care so the disparities we have today are diminished."

Building coalitions

For the institutions involved in Health Sciences South Carolina, the initiative is expected to enhance their current research efforts by joining universities with hospital systems.

"We’re the only state that I’m aware of where hospitals have come to the table and said, I want to be part of building life sciences in the state,’" Greenberg says. "That’s part of the reason we went to the hospitals, because we don’t have a huge pharmaceutical and other life sciences presence in the state."

The initiative will satisfy goals for the hospital players as well.

"We have been involved in research, but this promises to take us to the next level," says Jim Raymond, MD, senior vice president for medical education and research at Palmetto Health, which owns three hospitals, including a major teaching hospital, 11 residency programs, six fellowship programs, 220 residents and fellows, and 150 full-time faculty.

"We’ve had clinical trials efforts, which have grown in magnitude in the last 10-15 years, and that is our principal interest in this new collaboration, to help us extend and grow the scope of our clinical research activities," he says.

"First, it allows us to leverage our resources and take advantage of the endowed chair money," Raymond adds. "Secondly, it ties us more closely together and gives us the opportunity to do collaborative research, which we’ve never really done very well before."

More research needed

The collaborating partners also hope the new research organization will make South Carolina very attractive to pharmaceutical and biotechnology companies as they plan clinical trials.

"Instead of having to sign up a number of individual, small placement organizations, here’s an opportunity for them to sign up an entire state under one arrangement for a clinical trial," says Jerry Youkey, MD, vice president for medical and academic services at GHS.

One way that GHS officials compare the state’s collaboration with the research opportunities available in large metropolitan areas is to point out that the state of South Carolina’s population is comparable to the greater Atlanta area, he notes.

The fact that competing universities and health systems are willing to work together is another unique feature of the effort, Youkey reports.

"In the past, this has not been possible in other areas of the country," he says.

The institutions involved in the collaboration have had some previous research partnerships that helped pave the way for the more ambitious collaboration, Greenberg notes.

"MUSC, Palmetto Health, and GHS have been working together for four or five years on issues related to clinical care, and we share much in common in terms of clinical care activities," he says.

Also, MUSC and USC have been working on integrations of overlapping programs, such as the merger of their two pharmacy schools, Greenberg adds.

"We are moving toward recruitment of a single dean who will oversee the process of a single accreditation for the two schools," Greenberg says.

Pooling resources

While MUSC and USC are completely separate institutions that have been competitive in the area research, the collaboration will be an efficient way of pooling resources, Greenberg reports.

"South Carolina is a relatively small state with moderate resources, so we hope we can consolidate resources to create something that would compete with the best institutions in the country," he says.

Last year, MUSC had about $170 million in research activities, and USC had about $150 million in research funding, Greenberg says.

MUSC and USC also plan to create a new research foundation that would be the sponsoring organization for both universities, Pastides notes.

"So there would be no need to subcontract between the two institutions," he says.

With the planned research endowment, the collaboration is expected to attract more scientists to the state and create large pools of potential research subjects, which will attract interest from pharmaceutical and other sponsors, Greenberg says.

"To get the critical mass necessary for large clinical trials, we need to build a bridge across the population of the state," he says.

The collaboration also could help the partners expand into new areas of research, such as memory disorders, Youkey says.

"With the banner of a single program, we could recruit researchers to Greenville who then will have relationships with Columbia and Charleston and build resources around a single, directed program rather than three different programs," he says. "They’re much more likely to get a bigger bang for their buck rather than having to work separately with three different locations."

And Health Sciences South Carolina may pool pathology resources to form a common tissue bank that could be used in cancer and other trials, Pastides says.

Ultimately, the IRB process could be centralized, as would the clinical trials office operations.

"Our goal is to have one IRB process and one compliance process and to have a single integrated infrastructure so investigators don’t have to deal with multiple review boards and bureaucracies," Greenberg says.