NIH Roadmap for Medical Research

Executive Summary

The NIH Roadmap for Medical Research briefing was opened by NIH Deputy Director Dr. Raynard Kington, who explained that this briefing would provide a general overview of the NIH Roadmap, an update on the current status of initiatives, and answers to questions. Routinely updated information, announcements, and answers to frequently asked questions will continue to be posted on the Roadmap Web site at www.nihroadmap.nih.gov.

Dr. Elias Zerhouni, NIH Director, summarized the current research and budgetary climate and addressed key questions about why the Roadmap was developed, how it was developed, how it is being implemented, the specific initiatives, and how the Roadmap will benefit various research areas. The NIH Roadmap was developed through extensive consultations with stakeholders and is a framework of priorities that the NIH as a whole must address in order to optimize its research portfolio. The three major initiatives/themes of the NIH Roadmap are New Pathways to Discovery, Research Teams of the Future, and Re-engineering of the Clinical Research Enterprise. The convergence of science and the complexity of the building blocks of biological systems require the adoption of new approaches to research and acceleration of the pace of scientific discovery. The key to the Roadmap's success is to use a small portion of the NIH budget (less than 1 percent) to invest in high-risk, novel research with the potential to transform the field. In 2004 the Roadmap budget will be $128 million; in total, the NIH expects to spend approximately $2.17 billion on the Roadmap Initiative, which represents cumulatively approximately 0.9 percent of the NIH budget.

Dr. Dushanka Kleinman, Assistant Director for Roadmap Coordination, moderated the initiative presentations and discussion. She mentioned that project teams with representatives from all institutes and centers are managing Roadmap initiatives of the nine working groups. These working groups are co-chaired by institute or center directors. Only select initiatives from each theme area are highlighted in this two hour session. For a complete overview and periodic updates, participants should access the Web site (nihroadmap.nih.gov), and sign up for the NIH Roadmap listserv.

New Pathways to Discovery

Initiatives under the theme of New Pathways to Discovery are aimed at addressing the need to advance our understanding of the complexity of biologic systems and building a better "toolbox" for medical research in the 21st century.

Dr. Francis Collins, Director of the National Human Genome Research Institute, talked about the molecular libraries and imaging initiative. During the next few years, at least six National Screening Centers for Small Molecules will be established. Associated with these libraries will be a publicly accessible database for chemical genomics; also supported will be technology advances in combinatorial chemistry, robotics, and virtual screening. All of this information will populate the chemistry database called PubChem. The outcome of the molecular imaging initiative will be the development of research tools to facilitate studies in biology and pathophysiology. The goal is to develop a wide array of small-molecule probes to help investigators understand how life works.

Dr. Jeremy Berg, Director of the National Institute of General Medical Sciences, discussed the Roadmap's Structural Biology Initiative. In 2004, $5 million is available to fund two centers for innovation in membrane protein production. The Protein Structure Initiative is a network of centers devoted to improving the rate at which protein structures are determined. The initiative on bioinformatics and computational biology will feature the National Centers for Biomedical Computing; $12 million is available this year to fund four national centers. Designed as partnerships among computer scientists, biomedical computational scientists, and experimental and clinical biomedical and behavioral researchers, each Center will develop software tools for specific biological projects; the software and its source code will be available for modification and implementation in other areas. The Nanomedicine Roadmap Initiative will integrate biomedical processes with the goal of developing therapies; new tools and a nanomedicine lexicon are needed.

Research Themes of the Future

The Research Teams of the Future initiatives focus on preparing the research workforce and scientific institutions to harness and extend scientific advances through interdisciplinary research, high risk research and public-private partnerships.

Dr. Lawrence Tabak, Director of the National Institute of Dental and Craniofacial Research, discussed Interdisciplinary Research Teams of the Future. He began by describing the differences between multi and interdisciplinary research, and discussed challenges to interdisciplinary research. Dr. Tabak described two interdisciplinary research Requests for Applications (RFAs)—the Exploratory Centers for Interdisciplinary Research (P20 awards) and Supplements for Methodologic Innovations in the Behavioral and Social Sciences. The purpose of the Exploratory Centers P20s is to plan exploratory centers that can overcome barriers to conducting interdisciplinary research. Supplements for Methodologic Innovations in the Behavioral and Social Sciences are planned to develop innovative methodologies in social and behavioral sciences research areas.

Dr. Patricia Grady, Director of the National Institute of Nursing Research, discussed the importance of a research workforce trained to conduct interdisciplinary research. Four interdisciplinary research RFAs are related to training. The first RFA will develop and implement novel training programs by building on existing multidisciplinary and interdisciplinary research programs and infrastructure. The second RFA provides for formal coursework and research training in a new interdisciplinary field for individuals possessing advanced degrees in a different discipline. The third RFA is a curriculum development award in interdisciplinary research that supports the development of innovative courses and curricula to train interdisciplinary scientists. The fourth training RFA will focus on short programs that will provide a backdrop for the fusion of information, research practices, and technologies. In addition, for $500,000 over five years, the NIH Director's Pioneer Award will support researchers with untested and potentially groundbreaking ideas.

Re-engineering the Clinical Research

The initiatives under the theme of Re-engineering the Clinical Research Enterprise cover training and workforce needs, translational research, assessment of patient-reported outcomes, interoperability of clinical research networks, clinical research informatics and coordination and analysis of clinical research policies.

Dr. Stephen Katz, Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, talked about re-engineering the clinical research enterprise. A key element of this initiative is a national "network of networks" made possible by the development of data and vocabulary standards, shared software applications and tools, and common informatics platforms and architectures. This will greatly enhance the efficiency and effectiveness of such activities as protocol preparation, institutional review board management, and adverse event reporting. Other initiatives developed or under consideration include expansion of the NIH intramural clinical research training program, an advanced degree program for clinical research, a trans-NIH K12 clinical research career development award, and a national clinical research associates program. The Trans-NIH Multidisciplinary K12 Career Development Program (an RFA) will train investigators from a variety of disciplines in multidisciplinary team settings and will include five years of training with core didactic courses in clinical research.

Dr. Amy Patterson, Director of the NIH Office of Biotechnology Activities, discussed the Clinical Research Policy Analysis and Coordination component of the NIH Roadmap. This "Harmonization Initiative" will include working in concert with agencies such as the U.S. Food and Drug Administration, the Office for Human Research Protections, the U.S. Department of Veterans Affairs, and the Centers for Disease Control and Prevention to catalyze the Federal-wide transformation and coordination of the policies that govern clinical research.

Dr. Stephen Straus, Director of the National Center for Complementary and Alternative Medicine, discussed translational research dimensions of the Roadmap, focusing on translational research cores and regional translational research centers. The goals for these initiatives are to stimulate research at the bench-to-bedside interface, implement mechanisms to prepare novel products for preclinical and clinical studies, ensure adequate support for regulatory oversight data management and specimen analysis, increase the sensitivity and impact of early-phase clinical studies, and invest sufficiently in a modest number of programs to facilitate research at many institutions. The Translational Research Core Services initiative will support early preclinical development of small molecules for therapeutic applications. Regional Translational Research Centers will make available to investigators more robust regulatory, statistical, bioethics, and data management support; build cores for more sophisticated technologies than currently exist in general clinical research center programs; and support bench-to-bedside and pilot projects and translational research fellows programs.

The discussion covered topics related to the peer review of interdisciplinary research, collaborations among agencies and with professional and voluntary organizations, benefit of Roadmap initiatives to all institutes and centers, and the role of physical sciences in biology among others.

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