2009 Budget Statement

Testimony Prepared for the House Subcommittee on Labor-HHS-Education Appropriations

Dr. Barbara M. Alving, Director
National Center for Research Resources
National Institutes of Health

March 5, 2008

Mr. Chairman and Members of the Committee:

It is a privilege to present to you the President's budget request for the National Center for Research Resources (NCRR) for Fiscal Year (FY) 2009. The Fiscal Year (FY) 2009 budget of $1,160,473,000 includes an increase of $11,027,000 over the FY 2008 appropriated level of $1,149,446,000.

The mission of the NCRR, which is one of the 27 Institutes and Centers at the National Institutes of Health (NIH), is to increase the efficiency and impact of investigators who are studying ways to prevent and treat diseases that affect human health. Across the nation, NCRR provides resources and training for research that extends from the laboratory to clinical trials and then into public practice.

Building a Matrix for Clinical and Translational Science

NIH recognizes the need to develop multidisciplinary teams to conduct research that can be translated from the laboratory into clinical trials and further translated into the community through practicing physicians interacting directly with patients. These multidisciplinary teams need to conduct their research in integrated homes at their academic health centers, while also working together as a consortium across the country. The homes also need to provide the training ground for the next generation of clinical and translational researchers, including physicians, basic scientists, and nurses.

Therefore, in 2006, NCRR launched the Clinical and Translational Science Awards (CTSAs) program, a partnership between the NIH and the awardees to work as a consortium to build these academic homes. Twelve awards were made in FY 2006 and 12 more were made in FY 2007. The ultimate goal is to fund 60 CTSAs by 2012.

The consortium currently has three very high priorities: standardizing clinical research informatics; improving the way in which clinical studies and trials are developed, implemented, and monitored (clinical research management); and developing core competencies, part of the national curricula to train the next generations of clinical and translational investigators.

The CTSA institutions are highly interactive with the other major programs funded by NCRR, such as the Institutional Development Awards (IDeA) and the Research Centers in Minority Institutions (RCMI). For example, three of the 12 new CTSA grantees have partnerships with RCMIs: Emory University (Atlanta, Georgia) is partnering with Morehouse School of Medicine; Vanderbilt University (Nashville, Tennessee) is partnering with Meharry Medical College; and Weill Cornell Medical College (New York, New York) is partnering with Hunter College. Additionally, the University of Washington, a CTSA grantee, is partnering with academic institutions in IDeA states, creating greater opportunities to reach rural populations.

Fostering Translational Research

At NCRR, animal models are a critical component to our translational research portfolio as they bridge the gap between basic science and human medicine. For example, two recent advances in stem cell research were partially supported through our National Primate Research Centers (NPRCs). These advances build on the long standing NCRR support for animal stem cell research. For the first time, scientists have derived monkey embryonic stem cells by nuclear transfer, thus paving the way for the development of additional monkey models of specific human diseases. The second advance involves derivation of human pluripotent stem cells from skin cells, which may obviate many of the ethical concerns about derivation of human embryonic stem cells. Although both of these technologies are in a very early stage of development, they could help to significantly advance the field of regenerative medicine.

The potential to accelerate research discoveries between animal models and humans is one of the many benefits of the expanding partnerships among the CTSAs and the National Primate Research Centers (NPRCs). Researchers at the CTSAs and NPRCs are sharing their expertise and developing research approaches that maximize what is known in human and nonhuman primate models of disease. At the same time, the CTSAs are benefiting from increased access to the translational expertise in our Biomedical Technology Research Resources (BTRRs). The BTRRs are powerful interdisciplinary engines for the translation of advances in the physical and computational sciences into the cutting-edge technological infrastructure that underpins much of modern biomedical research. The CTSAs are leveraging these unique resources to create new diagnostic tests, to adopt advanced research computing infrastructure, and to explore the molecular fingerprints of various diseases. For example, the Translational Biomedical Imaging Center at the University of Pennsylvania CTSA is fully integrated with the Metabolic Magnetic Resonance and Computing Center, an NCRR-supported BTRR. They are working together to move advanced imaging modalities into the clinic.

Engaging Communities in Research and Dissemination

CTSA funding at the University of Pittsburgh has established the Community PARTners (Partnering to Assist Research and Translation) Program to coordinate community engagement activities. It facilitates community involvement by providing researchers with training to work with communities and encouraging community health care providers to participate in research.

CTSA researchers at Mayo Clinic are moving clinical research outside of its traditional setting to the bedsides of acutely ill patients, as well as operating and emergency rooms, and into the community. Currently, the Mobile Clinical Research Unit's trained research nurses and technicians are collecting specimens, administering study drugs, and gathering data for more than 20 research studies. To meet the increased demand for the mobile unit, six additional staff members were hired, and soon the unit will offer 24 hour coverage.

Similarly, connections between the CTSA consortium and our Science Education Partnership Award (SEPA) program are growing, helping to inspire the next generation of researchers. At the University of Texas Health Sciences Center at Houston, interactions between these programs are helping educators and researchers reach out to communities to bring NIH health messages to a wider audience while building awareness of the value of clinical research.

In addition to CTSA activities, the new RCMI Translational Research Network (RTRN) will provide investigators the opportunity to pool resources and expertise to conduct high quality, collaborative, multi-center research that will increase the productivity and impact of each of the individual centers. It is designed to integrate clinical, biomedical, and behavioral research with community health providers and community leaders to form geographic and ethnically diverse research partnerships.

Training Clinical and Translational Researchers

The CTSA Education and Career Development Steering Committee is working to ensure that well-trained clinician-scientists are available to carryout the transformation of clinical and translational science. The committee is focused on three major areas: improving scholar retention, developing a national set of core competencies for training, and encouraging more uniformity among the trans-NIH mentored career development awards. To reach consensus on the core competencies required for training master- and doctoral-level clinician-scientists, the committee hosted a workshop in January 2008 that brought together training directors. The core competencies will help define the discipline of clinical and translational science and will be aligned with the training curriculum adopted by each CTSA institution.

Improving Research Informatics and Connectivity

The CTSA consortium offers a unique opportunity for a collaboration of informaticists, computer scientists, clinician researchers, coordinators, and laboratory scientists to develop interoperable systems, standards, best practices, and technology. NCRR is currently seeking proposals for pilot projects from across the consortium to provide informatics tools to enhance the collection and management of study data.

At the Vanderbilt University CTSA, informatics experts are improving clinical research management by developing innovative informatics tools. Their interactive, Web-based system provides researchers with easy access to resources, experts, and regulatory support. Additionally, it helps researchers navigate through the research process by clearly identifying and tracking the status of the numerous mandatory approvals needed to start a research study. Innovative systems like this will reduce the time needed to implement research studies and help improve regulatory compliance.

NCRR also remains committed to enhancing network connectivity so that research institutions in underserved states can participate in bandwidth-intensive science applications. The Northeast Network Initiative, launched in FY 2007, is a collaborative effort to improve access to research networks and resources and facilitate collaboration in five IDeA states (Delaware, New Hampshire, Maine, Rhode Island, and Vermont). The Initiative is modeled after the NCRR Lariat pilot program, which enhanced connectivity in the western United States.

Leveraging Research Investments

Individual CTSA institutions are leveraging their awards to speed the transformation of clinical and translational science. Recently, the New York state government allocated $50 million to the University of Rochester to complete its Clinical and Translational Science Building, which state leaders recognized for its potential to advance medical science and contribute to regional economic development. In addition to serving as the home for the CTSA investigators, the building will house the Upstate New York Translational Research Network, a consortium of ten major medical institutions from Albany to Buffalo that will foster regional collaboration. Similarly, CTSA funding at the University of Iowa (UI) has brought together 39 established university centers and institutes representing all 11 UI colleges.

NCRR's goals are to build a matrix of clinical and translational research programs as well as leverage partnerships and improve research informatics and connectivity. Through enhanced community engagement and improved technologies that benefit our diverse population, we are maximizing our research investment and ensuring that medical advances are reaching the people who need them.