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Translating Opportunity

GW’s School of Medicine and Health Sciences, the Milken Institute School of Public Health at GW, and Children’s National Health System Earn Renewal of their Five-Year Clinical and Translational Science Award

by Eric Butterman

What we learn about childhood diseases today can potentially affect present efforts in fighting ailments plaguing adults — and the partnership between the George Washington University (GW) School of Medicine and Health Sciences (SMHS), the Milken Institute School of Public Health at GW, and Children’s National Health System (Children’s National) is allowing for significant strides, thanks to the Clinical and Translational Science Award (CTSA).

Translating Opportunity

The $23 million grant represents not just a five-year extension to the original award the partnering institutions received in 2010, but it also is an expansion of the organizations’ original goals: enhancing clinical and translational research; overcoming research barriers and promoting collaborative research; providing research training; and focusing on health disparities and childhood forerunners to adult diseases.

The partnership, known as the Clinical and Translational Science Institute at Children’s National (CTSI-CN), continues to be the only CTSA program out of the 64 in the nation with an emphasis on children, according to Robert Miller, Ph.D., senior associate dean for research, Vivian Gill Distinguished Research Professor, and professor of anatomy and regenerative biology at SMHS.

Lisa Guay-Woodford, M.D., director of the CTSI-CN, Richard L. Hudson Professor of Pediatrics at Children’s National, and associate vice president for clinical and translational research at GW, says the second version of the CTSA will answer a few central questions: What are the challenges for child health in translational science? How can we help investigators who want to take them on?  How can we help these investigators in developing studies that can be done across the consortia? And, from an extended perspective, how can we interact with other CTSA programs to develop best practices from which all can benefit?

“I think the CTSA program nationally is all about being sure that people are really prepared to do effective clinical and translational research, to do it an efficient way where we don’t waste people’s time or resources, and where we really kind of get to the nut of the issue as quickly as possible,” Guay-Woodford says.

To maximize that efficiency, CTSI-CN will use the renewal grant to focus on informatics, workforce development, collaboration, and community engagement.

By the Numbers

Informatics, or the science of information, is right out in front in terms of the CTSA program’s focus. Informatics holds the power to advance care, but challenges remain in the collection and sharing of patient data, says Lawrence Deyton, M.D. ’85, M.S.P.H., senior associate dean for clinical public health and professor of medicine at SMHS, and co-director of the regulatory knowledge and science core for CTSI-CN.

Translating Opportunity

“There are many disciplines crossing and in different kinds of research,” Deyton says. “It goes from basic lab research to genetics research to even public health research. But for all aspects, there are requirements in terms of ethics and transparency, and it’s important to do research in a way where patients and the community know what’s going on and that participants consent with full knowledge.”

A prime challenge is putting together an information system that allows the medical community access to informatics in a way that is effective and well-organized. “There’s a lot of data and you need to query those data efficiently and manipulate it efficiently so the information is in a safe and cyber secure environment — that’s the trick,” says Keith A. Crandall, Ph.D., director of GW’s Computational Biology Institute in the Milken Institute School of Public Health. “We have an exceptional team working on this. From bioinformatics platforms to tool developers to data analyzers to cybersecurity experts and internet trafficking experts, we collaborated with the Division of Information Technology on this proposal because they know the ins and outs of data security and how to move data around from place to place efficiently and securely.”

Fielding Your Team

Translational Workforce Development is another vital area, says Guay-Woodford. She compares it to choosing occupational therapists or psychotherapists to put on your research team. They can be a great asset, but it’s like asking a soccer player to make a game-day switch to baseball — the players are great athletes, but you need to show them how to play the game and give them the tools to succeed.

Just as there are different positions with unique roles and responsibilities on the athletic field, the CTSI-CN is customizing on-demand training to different groups to match their needs. One example is training for clinical research associates; they need to become savvy about regulatory, billing, and data management issues.

From Guay-Woodford’s perspective, if everybody on the team understands the game that is being played, what their role is, and what they need to do to work well together, you’ll end up with a winning team.

Amanda Kasper, M.P.H. ’09, director of operations for CTSI-CN, also likes how the award extends to a wide breadth of talent. “Educating and preparing the faculty reaches wide, to the nursing staff, clinical research staff, and beyond,” she says. “We want it to be across the workforce, using existing and new educational activities. A highlight is the number of internships being offered to scholars … to spend time in prestigious organizations and get hands-on experience is very valuable.”

Playing to Your Strengths

The award also allows for the individual CTSA program to choose a pair of optional modules on which to focus. Orphan product acceleration, or the development of treatment options for rare diseases, is something about which many of the researchers involved with CTSI-CN are excited.

“We have a really strong history of drug development, particularly in the muscular dystrophy space and also pediatric device development,” Guay-Woodford says. The idea of this module was to provide an entry for an interested investigator to understand the steps needed to go down a path of drug development or device development, among them dealing with regulatory issues and business planning.

The other module, Child Health Research Acceleration through Multisite Planning, or CHAMP, focuses on how investigators from multiple institutions can work together on research and act on issues such as recruitment, ethics, and data collection. A team-building immersion boot camp to be held annually at the University of California Irvine, focuses on the CHAMP themes, such as building a team through intrastream communication and how a team operates together.

Community involvement also remains an important feature of the CTSI-CN now that it’s shifted to the second version. A standout, Kasper says, is Science Café, a quarterly event held at Washington, D.C. staple Busboys and Poets, where community members participate in a discussion on medical topics. “It’s a chance to share research and help the community at large learn about a disease,” she says. “We’ve seen many people come to the event connected to the disease topic being featured in some way, [and] subjects have included sickle cell and asthma. The community engagement team works hard with the community to figure out their defined needs of what they want to learn about. Our advisory group of parents and community members are vital in giving us insight on possible programs for the community.”

Just as there are different positions with unique roles and responsibilities on the athletic field, the CTSI-CN is customizing on-demand training to different groups to match their needs.

Looking Downstream

In a presentation to the SMHS Dean’s Council, Guay-Woodford says one strength of the CTSA is the opportunity to cross-train researchers and clinicians. “We will help investigators build their databases, recruit their patients, design their studies, prepare their IRB proposal, run their studies, and help them with community outreach,” she said during the talk.

It’s early, but Kasper sees the second round of this partnership flourishing since the award was given in July, and she is optimistic about what’s coming next. “Downstream, you see the effects of the clinical trials that are going through, and you see the infrastructure moving innovations that much more,” she says. “This is a great fusion of two institutions combining strengths.”

With empowering assistance to the medical community, Miller believes this second five-year cycle has a chance to lead to an incredible period of prosperity.

“So much of this builds through the community working together, but also among the CTSAs,” he says. “It makes us strong to have such a large number of people at the ready to share insights.”