Developing a Regional Clinical Research Powerhouse

Posted in GUMC Stories

SEPTEMBER 3, 2015—Just a few years ago, Georgetown University Medical Center researchers struggled to enroll patients in clinical trials that could advance their medical care. Beyond the one hospital linked to GUMC, access to patients being treated in the D.C. area was limited, as were many aspects of the infrastructure necessary to perform clinical research studies.

Now, medical scientists at Georgetown, as well as Howard University, the MedStar Health Research Institute (encompassing MedStar Health’s 10 hospitals) and the Washington DC VA Medical Center (with its hospital and five clinics), are working together to continue its broad support of clinical and translational research — improving health care by developing and testing targeted, next generation treatments for all human diseases. In addition, clinical researchers are collaborating with scientists at the Oak Ridge National Laboratory to analyze large volumes of dynamic biomedical data with increasing levels of speed and efficiency.

These D.C.-area hospitals and their clinics treat more than four million patients each year — approximately 20 percent of the population in the mid-Atlantic region.

Combining the five institutions into one research powerhouse is creating one of the largest integrated clinical trials networks in the country, says Joseph Verbalis, MD , chief of the division of endocrinology and metabolism and professor of medicine at GUMC.

This opportunity was made possible by the National Institutes of Health, which granted Georgetown and Howard University a Clinical & Translational Science Award (CTSA) in 2010. This August, a new grant was awarded for $27 million over the next five years (NIH grant #UL1TR001409-01).

“The Georgetown-Howard Universities Center for Clinical and Translational Science is an excellent model for creating complex, robust collaborations spanning multiple institutions,” says Edward Healton, MD, MPH , executive vice president at GUMC and executive dean of the School of Medicine. “Translating research findings from a pre-clinical laboratory to be quickly studied in patients, possibly improving their treatment, is a critical aspect of what research institutions should do. With the work of the renewed CTSA, Georgetown and our collaborators have dramatically accelerated this activity.”

“… we accomplished everything that we said we would …”

The Georgetown-Howard CTSA, known as the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS), is one of 62 clinical research hubs in the United States created by the NIH’s National Center for Advancing Translational Sciences CTSA Program.

“Our mission is not only to stimulate clinical research in the area, but also to encourage the participation of underserved populations and their communities in that research,” says Thomas Mellman, MD, professor of psychiatry at Howard University College of Medicine. “The award is also intended to foster the development of the next generation of clinical researchers.”

The GHUCCTS CTSA was granted to co-principal investigators Verbalis and Mellman. They are co-directors of an executive committee that includes representations from GHUCCTS partner institutions — MedStar Health Research Institute, the Washington DC VA Medical Center and Oak Ridge National Laboratory.

This centralized management structure has “improved the quality and expanded the breadth of clinical and translational research capacity and enhanced the expertise available at each institution,” Verbalis says.

“In addition to expediting clinical research, I think the first five years as a CTSA have been marked by extraordinary creative cooperation between our institutions,” he says. “Our unprecedented data sharing agreement across our participating institutions allows us to identify patients who meet criteria to participate in clinical studies, and to perform those studies in an ethical, scientifically appropriate manner as rapidly as possible. We then know more quickly whether new therapies can help treat specific diseases.”

The GHUCCTS renewal application received a score of “outstanding,” which is one of the highest scores given by NIH study section reviewers, Verbalis says. “That is essentially because we accomplished everything we said we would during our first five-year award.”

One signpost of that collaboration is MedStar’s ongoing initiative to “make every patient a research patient and every doctor a potential collaborator for research.”

Collaboration has produced more than 400 publications to date

The new CTSA grant will allow GHUCCTS to connect its burgeoning clinical research network to other local and national CTSA networks, and to liaise with industry and government research, says Mellman.

“We will be even more productive during our next phase — we have laid down a solid foundation for GHUCCTS and we’ll now build on it,” he says. “There have been many accomplishments during our first five years.”

For example, there have already been more than 440 studies in the last five years that benefitted from GHUCCTS support via its many programs, from pilot grants, to bioinformatics and biostatistical advice, to use of core laboratories across all five GHUCCTS institutions.

Mellman and Verbalis highlight a few of the many other achievements where GHUCCTS has played a role:

A laboratory discovery that suggests an already approved cancer drug might be beneficial in treating Parkinson’s disease. GHUCCTS helped launch a clinical trial to study the observation.
Collaborations developing new antiviral approaches to treating HIV
Collaborations utilizing new approaches in cognitive behavioral therapy to treat trauma-related sleep disturbances
New findings regarding the pathophysiology of Alzheimer’s disease —particularly in minority patients
Development of a novel method to create conditionally reprogrammed cells to use in studying and treating a wide variety of cancers
Development of a blood test that can predict with greater than 90 percent accuracy if a healthy person will develop mild cognitive impairment or Alzheimer’s disease within three years
Identification of risk genes linked to cancers that disproportionately affect African-Americans
Identification of racial disparities in acute care of ischemic stroke

“… innovative and powerful solutions …”

Collaborating with clinical researchers has been, and will continue to be, a remarkable experience, says Oak Ridge National Laboratory’s executive committee member Kristina (Munoz-Flores) Thiagarajan, PhD, MN, RN, director of translational health sciences.

“With the Department of Energy’s high performance computing power, we are radically changing the methodology for predicting drug toxicity and repurposing drugs that were once shelved,” she says. “Computer scientists, engineers, chemists, physicists, and biologists, working with physicians and nurses, together are creating innovative and powerful solutions to daunting health care challenges.

“The CTSA is allowing us to pull the nation’s greatest strengths together — its interdisciplinary mind power and technological resources that are moving the forefront of medicine to places we can hardly imagine,” Thiagarajan says.

“MedStar Health is proud to be a partner with Georgetown, Howard University and the other collaborators for the CTSA renewal. This next phase of the CTSA will further our collective goals of advancing health through research, bringing research opportunities to the community and translating research results into improved care,” says Neil Weissman, MD , president of MedStar Health Research Institute. “Under the new grant, we will together create a multi-site research support system and a centralized recruitment effort that allows every MedStar patient to participate in clinical research and essentially allows every physician across the MedStar system become a collaborator. I am excited about bringing academics and real world medicine together to advance health.”

Training the clinical and translational researchers of the future

In addition to supporting the infrastructure necessary to speed advances in health care, the CTSA program is also charged with training the clinical investigators of the future. For that reason, the new GHUCCTS award includes funds to provide protected time and mentorship for young faculty to develop their research careers. This program, directed by Jason Umans, MD, PhD , has already provided support to nine faculty members at GUMC, Howard and MedStar over the last five years, which will now continue under Umans’ leadership for the next five years.

Moreover, GHUCCTS was selected as one of a small number of CTSA institutions that will provide training in translational science to predoctoral and postdoctoral trainees at Georgetown and Howard. Led by Kathryn Sandberg, PhD, this unique program will bring an even greater number of trainees into the arena of clinical and translational science at an early stage of their careers, thereby ensuring the future success of this field.

While the spirit of collaboration fostered by the CTSA has helped GHUCCTS earn a reputation as a leader in clinical and translational science, the new focus on developing the next generation of clinical investigators ensures GHUCCTS will remain at the cutting edge of the field.

“GHUCCTS is and will be at the forefront of advancing clinical and translational science both locally and nationally,” Verbalis says. “We have the dedicated and experienced personnel and the support of our respective institutions to achieve our mission to advance health care through innovative clinical and translational research, and train the clinical and translational researchers of the future.

“By working together, we can and will combine our strengths in ways that will impact health care to a far greater degree than our institutions could do individually,” Verbalis says. “This is the essence of ‘team science.’”

Renee Twombly
GUMC Communications