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Streamlining science

Though longtime tobacco researcher Dorothy Hatsukami, Ph.D., has her own staff, she still turns to the CTSI for research support. (Photo: Scott Streble)

The U’s Clinical and Translational Science Institute puts focus on bench-to-bedside research

By Dan Haugen

When Dorothy Hatsukami, Ph.D., began her University of Minnesota research career, investigators had to be “extraordinarily resourceful” to find everything they needed to conduct a study, from laboratory equipment to advice on filling out regulatory forms.

“Individual researchers had to do pretty much everything on their own,” says Hatsukami, a professor of psychiatry and director of the University’s Transdisciplinary Tobacco Use Research Center. It took time and sleuthing to get questions answered, forms completed, and studies set up and running. “There wasn’t one place that you could go to ask questions,” she recalls.

Today, 30 years later, that “one place” is finally becoming a reality for University researchers.

The Clinical and Translational Science Institute (CTSI), launched in April 2009, aims to be a one-stop shop for clinical and translational researchers. It’s doing so by centralizing research services that were previously spread out across several departments, as well as by investing in new, shared programs and technology that will be made available to all researchers, including offsite collaborators.

“The idea is integration for the purposes of highest efficiency, greatest patient safety, and optimum faculty and staff productivity,” says Bruce Blazar, M.D., the CTSI’s founding director and a Regents professor of pediatrics.

That may sound like a yawner, but it’s a big deal for scientists, doctors, and patients. That’s why the National Institutes of Health (NIH) just awarded the University a $51 million federal grant to accelerate the CTSI’s work, which also includes boosting community engagement and training the next generation of researchers and clinicians.

With the grant, the University joins a consortium of 60 Clinical and Translational Science Award (CTSA) health research centers across the country that are sharing resources and best practices in an effort to speed the translation of research discoveries into better patient care. The bottom-line outcome: more real-world cures, treatments, and best practices, says Frank Cerra, M.D., former senior vice president for health sciences and one of the CTSI’s leading proponents.

“It’s the infrastructure that will support an increased volume, on a shorter time line, of translational research that gets new knowledge into new treatments, new cures, and new companies,” he says. “That’s what this is about.”

Siloed approach in the past

Clinical and translational research at most institutions has tended to occur in silos and at a slow pace; on average, it takes 17 years for a lab discovery to actually benefit people, say CTSI leaders. All of the day-to-day and administrative tasks related to conducting studies have usually landed on the staff or department of the individual investigator, often on the shoulders of just one or two people for each area.

“As investigators, we were left to our own devices, so sometimes there would be duplication of effort in overcoming obstacles or challenges necessary to bring research forward,” says Blazar, who is a pediatric blood and marrow transplant physician.

In October 2005, the NIH announced it wanted to see a new, more efficient approach to clinical and translational research at the nation’s academic health centers. “We are truly at a crossroads in medicine,” the institutes’ then-director, Elias Zerhouni, said at the time. “The scientific advances of the past few years, such as the completion of the Human Genome Project, dictate that we act now to encourage fundamental changes in how we do clinical research, and how we train the new generations of clinician scientists for the medical challenges of this century.”

The NIH unveiled the CTSAs — large, multiyear grants to academic health centers and their community partners that can demonstrate a strong plan for reorganizing the way they support clinical and translational research. Among its priorities: lowering barriers across scientific disciplines, improving community engagement, and training the next generation of clinical and translational research scientists.

The University’s initial applications for the award fell short. After revamping the interdisciplinary research section and bolstering the Academic Health Center’s health informatics program, it was successful this year. In June, the NIH announced a five-year, $51 million award — the largest single-institution NIH award the University has ever received.

Aaron Kelly, Ph.D., talks to a research participant about next steps in his adolescent obesity program. (Photo: Scott Streble)

Growing data and complexity

The University has long been a leader in clinical and translational research, says Aaron Friedman, M.D., vice president for health sciences and dean of the Medical School. He points to the school’s history of developing new cancer treatments and transplant procedures, for example. The CTSA will help the University continue that success into the future, he says. “These awards provide the infrastructure to be able to do that kind of work the way it actually needs to be done in the 21st century.”

In the past, a well-organized spreadsheet and file cabinet might have been all the tools necessary to manage and analyze the data coming out of a clinical study. Today, though, both the volume and complexity of information researchers have to deal with has grown exponentially. “The amount of data has just exploded,” says Connie Delaney, Ph.D., R.N., dean of the School of Nursing and director of the Academic Health Center’s Biomedical Health Informatics program.

That data explosion has been driven by factors such as our knowledge of the human genome, the use of medical imaging technology, and the electronic health record. “Those are expansive amounts of data that, when used for discovery, enable us to deliver better care,” says Delaney. The availability of these data also requires clinical researchers to track, manage, and analyze far more information. Add the electronic medical record and a neverending stream of new scientific literature, and the data management burden on small research teams or departments gets to be overwhelming.

These trends make sharing and collaboration increasingly critical, something the NIH recognized when it designed the CTSA program.

Shared technicians, technology

The CTSI provides à la carte services for clinical researchers, from injecting medication and collecting blood samples to preparing grants and analyzing statistics.

As a senior researcher three decades into her career, Hatsukami has her own staff to manage most of the tasks related to running a research project. However, she still turns to the CTSI for help with certain functions. She conducts her clinical studies of tobacco users at the CTSI’s Delaware [Street] Clinical Research Unit, where the institute provides exam and observation rooms and CTSI staff can assist as needed with blood draws and other tasks. “Everything is here, in one place, for us to conduct studies,” says Hatsukami.

Meanwhile, the CTSI, integrally linked to the Institute for Health Informatics, led by Delaney, is investing in a suite of software, such as clinical trials management systems, that will be available for use by any University investigator. The goal is to establish a common and secure platform for managing clinical data, which should relieve the tech support burden on individual teams and departments, as well as make de-identified patient data easier to share with colleagues and collaborators across departments or multiple sites.

The ability to share technology and connect collaborators is critical to a current study by Aaron Kelly, Ph.D., an assistant professor of pediatric cardiology. He’s working with clinicians at Children’s Hospital and Clinics of Minnesota on a pediatric obesity study that is exploring the potential of an adult diabetes drug to help treat extreme obesity in adolescents. The study is funded by the CTSI, but it also relies on a piece of software provided by the institute called REDCap, which allows Kelly and his collaborators to collect and securely input data into the same database from either site.

“It’s important to have a secure system, and one that can be easily accessed and used across multiple centers,” says Kelly. “For a lot of us, setting up databases is not our expertise, so that kind of support is invaluable.”

Shared software and common practices for inputting data should also make it easier to share with other researchers, whether across campus or across the country.

CTSI founding director Bruce Blazar, M.D. (left), and Medical School Dean Aaron Friedman, M.D., expect a $51 million NIH grant to accelerate discovery that benefits the larger community. (Photo: Scott Streble)

Data + ideas + people

One of the CTSI’s primary goals is to build more cross-disciplinary collaborations among researchers and better connect researchers to communities outside the University’s walls.

In August, the institute launched a social network for University researchers called UMN Profiles, which can be used to help people find other investigators with like or complementary research interests and expertise.

The CTSI is also working with several community-led committees charged with developing partnerships among University researchers and communities across Minnesota. The committees — focused on child health, health disparities, rural health, and health care systems — will help to identify priority research topics, design studies, and disseminate the results of completed research.

“They’re going to help us identify the ways in which researchers from the University should approach and work with community partners,” says Andrea Leinberger-Jabari, coordinator for the CTSI community engagement efforts. “These leaders are closer to the community that they’re serving, so they can help researchers set the agenda and conduct research that ultimately helps build healthier communities.”

Mitchell Davis Jr., who chairs the University’s Community Health Advisory Council, one of the four committees, says he sees opportunity for a two-way conversation. The committee can call attention to new or overlooked research priorities and share advice on approaching people in their community. It can also play a role in distributing research results. “[Researchers are] not necessarily the ones who will know … who the influencers are,” says Davis.

Training the next generation

In addition to creating a shared infrastructure and improving community connections, the CTSI will stress training the next generation of clinical researchers and technicians. Plans call for developing new programs and courses to expose students to research careers earlier on and throughout their programs as well as continuing to provide mentorship opportunities.

Medical student Emily Mood says most of her exposure to clinical research has been either introductory or aimed at how to read and use research in practice. For some of her classmates, that was enough. But for her and others who entered the program with an interest in clinical research, there’s room for more emphasis.

“My friends who were interested in research and I thought it should have been given much more priority, and I think my friends who were less interested in research thought it was plenty the way it was,” says Mood. She’s spending her fifth year (through the Flexible M.D. program) in Mexico City working on a clinical environmental health study that will explore the interaction of lead exposure and maternal stress on childhood development.

Sarah Cusick, Ph.D., an assistant professor of global pediatrics, will be working to establish her research career over the next few years through the CTSI’s KL2 Scholars Program. The mentoring and career development program will pay 75 percent of her salary for the next three years and give her regular contact with three mentors, one of whom must be a statistician. Cusick, one of five KL2 scholars chosen this year, will be studying the interaction between infection and nutrition.

“It would be a lot more stressful right now” without the program, says Cusick. “I have this three-year breathing space. … I’m definitely learning the procedure for making research ideas become reality, but also learning to expand and enhance those research ideas, looking for outcomes that I might not have previously known to look for.”

Cultural shifts needed, too

CTSI leaders say they’ve made considerable progress in putting the institute’s pieces in place. Some functions are still ramping up and some software and technology still need to be purchased, but the $51 million NIH grant will accelerate the transition they started just over two years ago.

“We’re looking at a single clinical enterprise for translational research,” says Blazar. “We’re going to try to develop an approach that meets the needs of our investigators in a way that we haven’t been able to do before.”

Money can go only so far. For the CTSI and its grant to be successful, a cultural change will be required as well, says John E. Wagner, M.D., codirector of the University’s Center for Translational Medicine, now part of the CTSI (see sidebar).

The problem is that today, developing new therapies is too complex and too expensive to do alone, and the University can’t afford to duplicate services, Wagner says. “We have to really espouse the team culture — that the team is greater than the sum of its parts.”

Dan Haugen is a Minneapolis freelance writer who covers business, technology, and sustainability.

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