Center to Propel Research and Theory Out of Labs and Into Clinical Applications and Community Use

Through a major research initiative at the National Institutes of Health, Harvard has received substantial new funding to create a Clinical and Translational Science Center (CTSC). The five-year award is intended to accelerate the translation of research findings from bench to clinical application and from theory to community application. Harvard Medical School will be the lead institution and Harvard's teaching hospitals, the School of Public Health, and several other schools will have substantial roles. HSPH faculty will have important tasks in the development of the biostatistical science program (BSP), training of clinical/translational scientists, and community-based participatory research.

"The CTSC provides an important opportunity for Harvard to marshal its considerable strengths in research, training, and communication to speed the application of research findings to patient care and population health," said James Ware, Dean for Academic Affairs at HSPH and director of the BSP in the CTSC. "Several HSPH faculty members and academic units have played a large role in this effort. Our Department of Biostatistics has a major function in fostering the best methods for design and analyses of clinical trials. The Division of Public Health Practice will also have an important role, in collaboration with the Institute for Community Health at Cambridge Health Alliance, in translation to the community. This is a major development for clinical and population research at Harvard."

For many years, General Clinical Research Centers, which provide resources for both inpatient and outpatient research, have been a mainstay of NIH's effort to foster clinical research. Four Harvard-affiliated hospitals — MGH, Brigham and Women's Hospital, Children's Hospital, and Beth Israel Deaconess Medical Center — have been recipients of GCRC funding.

Clinical and Translational Science Awards

The GCRC program now has been replaced by the Clinical and Translational Science Awards program. CTS awards go to universities rather than hospitals. Recipients must commit to developing a program that spans all parts of the university, and education must have a central role in the program plan. 

Harvard is one of 14 institutions across the U.S. to receive a 2008 CTSC grant. The total amount awarded to all 14 institutions is $533 million over five years. Harvard will receive $23.5 million per year for five years. HSPH, HMS, other schools at the University, and affiliated hospitals have made substantial commitments of institutional funds to support the new Center.

Harvard's CTSC will be directed by Lee Nadler, the Virginia and D.K. Ludwig professor of medicine at the Dana-Farber Cancer Institute and HMS, and co-directed by Steven Freedman, HMS associate professor of medicine at Beth Israel Deaconess Medical Center. Nadler is also Dean for Clinical and Translational Research at HMS. Freedman is Associate Dean for Clinical and Translational Research at HMS. Laura Weisel is the executive director of the CTSC.

The NIH has identified key elements of CTS programs:

• Development of novel clinical and translational methodologies
• Pilot and collaborative translational and clinical studies
• Biomedical informatics
• Regulatory knowledge and support
• Participant and clinical interactions resources
• Community engagement
• Translational technologies and resources
• Research, education, training, and career development
• Design, biostatistics, and clinical research ethics
• Diversity and health care disparities research

Additionally, the CTSC will ensure that the needs of pediatrics investigators are represented in all aspects of the CTSC.

HSPH's Roles

Ware heads the biostatistics component of the Harvard CTSC, which has five local teams, or nodes. Four of the biostatistics nodes are at Harvard-affiliated hospitals and the fifth is at HSPH. Paul Catalano serves as an associate director representing the Dana-Farber Cancer Institute to provide a linkage to the Dana-Farber/Harvard Cancer Center.

Rebecca Betensky, professor of biostatistics at HSPH, is the associate director of the biostatistics node at the School. The HSPH node will be a resource for biostatistical collaboration and will also foster research on quantitative aspects of translational sciences, particularly issues related to emerging technologies such as genomics and new imaging modalities. The four other biostatistics nodes are directed by Dianne Finkelstein (MGH), Shelley Hurwitz (BWH), Les Kalish (CHB), and Shiva Gautam (BIDMC).

"Our department has a long history of development of statistical methods for clinical research, studies on the environment, genomics, and genetics," said Betensky. "The idea behind the CTSC is innovative. There will be opportunities for students to be trained in statistical consultation and collaboration and for faculty to serve as consultants and to develop nonstandard designs when required." Betensky anticipates that the BSP will organize seminars, workshops, and collaborative research opportunities.

The Program in Clinical Effectiveness will have a major role in CTSC. The program prepares new investigators, many of whom are fellows at Harvard hospitals, for careers in clinical research. The Program enrolls more than 150 new students each summer and has been fully subscribed for years. One of the challenges for the CTSC is the expansion of opportunities for training in research methodology.

And the School's Division of Public Health Practice will work with the Institute for Community Health at Cambridge Health Alliance and Massachusetts communities to expand the application of community-based participatory research to address important public health issues. According to Division Director Howard Koh, the CTSC will allow the Division to leverage even more effectively its growing ties with the Institute for Community Health as well as key community partners in urban Massachusetts that have recently led to a growing number of successful community-based grant collaborations.

"Harvard is highly decentralized," said Ware. "This is an opportunity for different parts of the University to work together to develop new educational resources and research programs designed to improve the health of patients and populations."

Making Connections

More information about the Harvard CTSC will be made available through an Internet portal called CONNECTS that will help researchers navigate resources at Harvard. The portal, still under development, will help researchers with related research goals find one another. The portal will also provide a resource called SHRINE (Shared Health Research Information Network), which will foster access to clinical data across participating hospitals. The Bioinformatics Core, directed by Isaac Kohane, director of the Countway Library and a prominent figure in computational biology, will take the lead in the development of SHRINE.

The CTSC leadership is recruiting several scientists who will act as research "navigators." They will act as consultants, helping to guide investigators toward resources and collaborators to help them achieve their goals. The CTSC will also distribute pilot grants for early translational and clinical studies, focusing on junior investigators who want to work across disciplines or institutions.

—Photo (c) iStockphoto.com/Damir Cudic