Strategic Initiatives

I. Building Capacity to Translate Biomedical Research into Practice

The photograph shows two doctors monitoring a newborn in a neonatal intensive care unit.

Cynthia McEvoy, M.D., a neonatologist, and Daniel Marks, M.D., Ph.D., a pediatric endocrinologist, tend to newborn Diego in the neonatal intensive care unit of the Doernbecher Children’s Hospital at the Oregon Health & Science University (a CTSA grantee) in Portland, Ore. Drs. McEvoy and Marks are collaborating on a study to look at the effects of maternal nutrition on prenatal development. The study is an extension of animal research that Dr. Marks conducted, which was supported through a pilot grant from NCRR’s CTSA program. (Photo Credit: Rick Rappaport Photography)

NCRR helps to build partnerships and networks among grantees to create a matrix in which the whole is much greater than the sum of the individual programs. Three of these programs demonstrate the range of NCRR-supported activities, including basic biomedical and behavioral research, integrated research infrastructure, mentoring and career development, and community outreach. Through the Clinical and Translational Science Award (CTSA) initiative, NCRR has launched a consortium to bridge basic, translational, and clinical research to bring effective prevention and treatment strategies more quickly into practice. The Institutional Development Award (IDeA) program supports and fosters health-related research at institutions in states where NIH support has historically been low, many of which have significant minority and medically underserved populations. NCRR’s Research Centers in Minority Institutions (RCMI) program builds capacity at minority institutions to bring more minority scientists into mainstream research, enhancing studies of minority health and reducing health disparities.

Strategy 1

Support efforts that will encourage increased quality and efficiency in the conduct of basic, clinical, and translational research.

Focused efforts are under way to increase the quality and efficiency of clinical and translational research. This will allow researchers to develop new knowledge and thus provide new treatments more quickly and effectively to patients across the country.

Action Items:

CTSA

NCRR will support the efforts of the CTSA consortium to:

Develop best practices, training, tools, workflows, databases, and analysis tools that assist investigators in the development and performance of clinical and translational protocols to quickly and efficiently address important questions in multiple areas of science, while assuring high quality and appropriate protection of human participants.
Develop metrics, workflow management, and communications to improve the efficiency of the clinical research process from start to finish.
Provide investigators with integrated training, services, or tools for protocol and informed consent authoring and tracking, adverse event reporting, safety, and regulatory management and compliance.
Share best practices that reduce institutional barriers and enhance inter-institutional collaboration.
Ensure that collaborative clinical and translational research activities are facilitated and are in compliance with the institutional review board (IRB) requirements, and ensure protection of research participants.

RCMI

NCRR will support the efforts of the RCMI program to:

Researchers in the laboratory of Donald E. Palm, Ph.D., at Florida A & M University College of Pharmacy and Pharmaceutical Sciences, investigate the molecular underpinnings of stroke and Parkinson’s disease to identify new treatment modalities. In this photo, postdoctoral fellow LeeShawn Thomas, Ph.D. (left), and master’s student Taaj Shelton prepare to examine the results of a Western blot, a technique used to detect the identity and size of a specific protein in a mixture of proteins. Florida A & M University is 1 of 18 locations that host the NCRR-supported RCMI program, whose mission is to expand the national capacity for research in the health sciences by assisting, through grant support, predominantly minority institutions that offer doctorate degrees in the health professions or health-related sciences to strengthen their research environment. (Photo Credit: Denise Gordon, Florida A & M University College of Pharmacy and Pharmaceutical Sciences)

Provide support for resources to facilitate basic biomedical research in RCMI sites.
Coordinate clinical and translational research activities by reorganizing the various RCMI clinical and translational research infrastructure-related activities into one integrated program called the RCMI Infrastructure for Clinical and Translational Research (RCTR).
Provide investigators in minority institutions with integrated training, core resources, and tools to improve the clinical and translational research process.
Use intra- and inter-institutional collaborations and partnerships to develop and share best practices for prevention, diagnosis, and/or treatment of diseases to reduce health disparities.

NCRR will increase the opportunity for multisite clinical and translational research among minority and other collaborating institutions through the RCMI Translational Research Network (RTRN). NCRR will support the efforts of the RTRN to:

Provide infrastructure to facilitate secure data entry, management, and sharing across multiple sites in support of collaborative clinical and translational research, including attention to national standards.
Serve as a national resource to facilitate multisite clinical and translational research in health disparity areas.
Promote the inclusion and participation of underrepresented minorities in clinical and translational research and training.

Strategy 2

Build research capacity in IDeA states.

NCRR will continue to support the two major activities of the IDeA program: the Centers of Biomedical Research Excellence (COBRE) and the IDeA Networks of Biomedical Research Excellence (INBRE). COBREs are thematic multidisciplinary centers that augment and strengthen institutional biomedical research capacity by expanding and developing biomedical faculty research capability and enhancing research infrastructure, including the establishment of core facilities needed to carry out the objectives of multidisciplinary, collaborative programs and facilitate the development of new disease-specific research centers or augment the capability of existing centers. INBREs support the development, coordination, and sharing of research resources and expertise to expand the research opportunities and increase the number of competitive investigators in the IDeA-eligible states. By doing so, the INBREs enhance the caliber of scientific faculty at research institutions and undergraduate schools, thereby attracting more promising students to biomedical research careers.

Action Items: NCRR will:

Build active biomedical research environments in U.S. states that do not receive significant NIH support in order to improve access to modern, state-of-the-art biomedical research for students, researchers, and the general public in these states.
Ensure that states without medical schools have an opportunity to develop research capacity to conduct basic biomedical research and that special populations within these states are included in clinical research.
Provide opportunities to address health disparities in medically underserved groups residing in IDeA states and to have members of these groups included in research conducted in non-IDeA states and nationally.
Foster opportunities for communities and tribal health centers, especially in IDeA-eligible states, to have access to health research opportunities and be included in clinical and translational research.
Promote technology transfer, entrepreneurship, and public-private partnerships to create and enhance vibrant translational research environments around IDeA-supported institutions.
Ensure increases in research capacity and competitiveness in IDeA-eligible states.
Provide opportunities for talented undergraduate students to participate in research training and research careers in the biomedical sciences.
Provide opportunities for bioinformatics cores and cyberinfrastructure networks to support biomedical sciences through INBRE.
Provide support for infrastructure and core facilities at COBRE institutions.
Encourage collaborations among IDeA research resource centers to capitalize on each other’s unique capabilities to solve complex research queries, and encourage consolidation of research resources that hold complementary technologies.

Three programs of NCRR—CTSA, RCMI, and IDeA—provide the integrated research infrastructure, community engagement, and mentoring/career development needed to underpin successful clinical and translational research. This map will evolve over the next five years and beyond as the CTSA program grows and additional collaborations form among the three programs.

NCRR’s CTSA program is creating academic homes for a new, unified discipline—clinical and translational science—at institutions across the country. Beginning in 2006 with 12 academic health centers located throughout the United States, the consortium will link about 60 institutions (www.CTSAweb.org).

The RCMI program is bolstering research capacity and infrastructure in institutions whose enrollment is at least 50 percent students from communities underrepresented in the biomedical sciences, including African Americans, Hispanics, American Indians, Alaska Natives, Native Hawaiians, and Pacific Islanders. Five of the 18 RCMI-supported institutions have clinical research centers with a special focus on health conditions that affect racial and ethnic minorities.

NCRR’s IDeA program is helping states with historically low rates of success in obtaining NIH funding by providing grants to institutions and communities in 23 states and Puerto Rico for biomedical research and outreach to unique populations. The IDeA program is producing a pipeline of homegrown researchers who will become leaders in competing for federal research dollars, a process that will ultimately lead to reductions in health disparities.

This map shows the current national distribution of RCMIs, RCMI/RCMI Clinical Research Centers, CTSA institutions, and IDeA states.

Click on a state for more information about centers or institutions in that state or region.

Strategy 3

Broadly and effectively engage communities in clinical and translational research.

Community outreach and engagement also are vital to ensure that research participants represent the rich diversity of the U.S. population, especially when addressing the special health concerns of high-risk populations and medically underserved and hard-to-reach communities. Working with community-based groups, such as voluntary and professional organizations, schools, women’s health groups, and housing organizations, will help to ensure that research results reach communities.

	Action Items:
CTSA	NCRR will support the efforts of the CTSA consortium and expand it to include the RCMI and IDeA academic research centers to: Engage patient advocacy groups, community groups, and their physicians in the research process from protocol idea through enrollment and study results dissemination. Engage the public in advancing health through recognition of the role of individuals in supporting and participating in clinical research and provide educational programs for the public on clinical research and its benefits. Foster bidirectional dialogues about community outreach, access, and dissemination of translational research results. Identify and establish partnerships to leverage additional support for community engagement activities. Develop evaluation outcomes and metrics for community engagement research. Convene workshops to accelerate the dissemination and translation of clinical research into practice.
IDeA	NCRR will continue to support a broad array of research, education, and training activities through the IDeA program to: Provide opportunities to address health disparities in medically underserved groups residing in IDeA states. Ensure that rural and remote communities and tribal health centers have access to health research and training opportunities.
RCMI and IDeA	NCRR will further build upon the unique resources of the RCMI and IDeA programs to: Capitalize on RCMI and IDeA grantees’ experience to successfully integrate population-based approaches, research in health disparities, and establishment of trusted relationships with communities to improve the conduct of translational and clinical research. Create the necessary biomedical research workforce by engaging K–12 and undergraduate academic institutions in the RCMI and IDeA communities, thus providing additional career development opportunities. Increase collaboration among RCMI, IDeA, and CTSA grantees to address challenges among populations who face much higher rates of disease, premature death, and disability than other populations. Working together, these programs can address challenges that exist in clinical and community-based research to engage members of racial and ethnic minority groups and people living in rural or inner-city areas.

The Center for Clinical and Translational Sciences (CCTS) is a collaboration of the University of Texas Health Science Center at Houston, the University of Texas M.D. Anderson Cancer Center, and the Memorial Hermann Healthcare System. Here, stroke researcher Nicole R. Gonzales, M.D., is testing a potential treatment for a hemorrhagic type of stroke. Dr. Gonzales is pictured with stroke survivor Joe Grant and his wife, Marie. Researchers also can utilize the services of the Genetics Core Lab, which provides DNA harvesting and banking, DNA genotyping, and DNA sequencing. Under the direction of Dianna Milewicz, M.D., Ph.D., the staff has the expertise to collect, analyze, and store data from biological materials. (Photo Credit: University of Texas Health Science Center at Houston)

Strategy 4

Engage RCMI and IDeA communities as equal partners within, across, and beyond programs and institutions.

RCMI and IDeA institutions provide critical research resources and have greater accessibility to minority and underserved communities. By training and supporting researchers who are representative of their communities, these institutions ensure a greater understanding of the needs and challenges unique to their communities. At the same time, RCMI and IDeA institutions can facilitate greater community involvement and participation in the research enterprise. By engaging as equal partners with other programs, these institutions will benefit from greater resources as well as provide valuable expertise and understanding in the research needs of their communities.

RCMI and IDeA	Action Item: NCRR will encourage equal partnerships between RCMI and IDeA institutions and CTSA and other NCRR programs through research collaborations, visiting professorships, work groups, and the sharing of resources and infrastructure.

Strategy 5

Demonstrate return on investment in basic, clinical, and translational science.

With such large investments across the research continuum, NCRR must demonstrate the return on such investment to its various stakeholders, including NIH partners, professional societies, the research community, Congress, and—ultimately—the public.

Action Items: NCRR will:

Pursue a comprehensive national evaluation of the CTSA program to determine the effectiveness of the consortium to achieve its goal to transform clinical and translational science.
Assess the contributions and impact of NCRR’s diverse programs and research portfolio on facilitating and conducting biomedical research and advancing the disciplines of clinical and translational science.