NIH Roadmap for Medical Research.

The National Institutes of Health (NIH) Roadmap for Medical Research is a collection of far-reaching initiatives designed to transform the Nation's medical research capabilities and improve the translation of research into practice. As described below, the Roadmap consists of three major themes: new pathways to discovery, research teams of the future, and reengineering the clinical research enterprise.

Molecular Libraries and Imaging. Small molecules, often with molecular weights of 500 or below, are important for researchers studying molecular and cel lular functions. Such molecules are valuable for treat ing diseases, and most medicines marketed today are from this class. With small-molecule libraries, biomed ical researchers in the public sector can have access to the large-scale screening necessary to identify small molecules that can be used as chemical probes for genes, cells, and metabolic and biochemical pathways. This will lead to new ways to explore the functions of genes and signaling pathways in health and disease.
The imaging component of this initiative focuses on the imaging of molecules or molecular events in biological systems that span the scale from single cells to whole organisms. Ultimately, this effort may enable personalized profiles of cell and tissue function, which may lead to more individualized approaches to diag nosing and treating disease.
Structural Biology. This effort aims to map the molec ular shapes of proteins in the body. This involves the development of rapid, efficient, and dependable meth ods to produce protein samples that researchers can use to determine the three-dimensional structure of a protein. The new effort is catalyzing what currently is a time-consuming process into a streamlined routine, helping researchers clarify the role of protein shape in health and disease.
Bioinformatics and Computational Biology. These initiatives are creating a national software engineering system to evaluate, combine, and visualize the large amounts of data collected through biomedical research. Through a computer-based grid, biologists, chemists, physicists, computer scientists, and physicians any where in the country will be able to share and analyze data using a common set of software tools.
Nanomedicine. An offshoot of nanotechnology, nanomedicine refers to highly specific medical inter vention at the molecular level for curing disease or repairing damaged tissues, such as bone, muscle, or nerve. The Nanomedicine Roadmap Initiative calls for the creation of Nanomedicine Development Centers, which are focusing on gathering information about the structures, processes, and networks inside cells. Researchers will use this information to develop tools to detect and correct biological defects in unhealthy cells.

The Human Microbiome Project.
Little is known about the communities of microbial cells that inhabit healthy human bodies. The Human Microbiome Project aims to study these cells and their role in human health and disease. New DNA sequencing technologies have created a field of research, called metagenomics, that allows the comprehensive study of microbial communities, even those composed of organisms that cannot be cultivated experimentally. Instead of exam ining the genome of an individual bacterial strain that has been grown in a laboratory, the metagenomic approach allows analysis of genetic material derived from complete microbial communities harvested from natural environments. In the human microbiome project, this method will complement genetic analyses of known isolated strains, providing unprece dented information about the complexity of human microbial communities.
Epigenomics. Epigenetics involves the study of changes in the regulation of gene activity and expression that are not dependent on gene sequence. Epigenomics is the global analyses of epigenetic changes across the entire genome. The NIH Roadmap epigenomics program is based on the hypothesis that the origins of health and susceptibility to disease are, in part, the result of epigenetic regulation of the genetic blueprint. In par ticular, this hypothesis suggests that epigenetic mecha nisms that control stem cell differentiation and organ formation contribute to the biological response to endogenous and exogenous forms of stimuli that result in disease. The epigenomics program aims to develop comprehensive reference epigenome maps and new technologies for comprehensive epigenomic analyses.

Reengineering the Clinical Research Enterprise
The following initiatives within this theme are central to the goal of moving research results more quickly into clinical settings.

Clinical Research Networks.
This initiative is focused on improving and expanding existing clinical research data networks and standardizing data reporting to improve networking. Another goal is to determine the feasibility of a National Electronic Clinical Trials/ Research Network (NECTAR), which will provide the informatics infrastructure that will serve as the back bone for interconnected and interoperable research networks.

Clinical Outcomes Assessment.
This initiative aims to develop new technologies to improve the assessment of patient-reported clinical outcomes, such as fatigue, pain, and mood changes.

Clinical Research Training.
Efforts within this initia tive are designed to expand and strengthen the clinical research workforce by supporting career development for clinical researchers, increasing the number of clinical researchers, diversifying the settings in which clinical research is conducted, and providing clinical research training for medical and dental students.

Clinical Research Policy Analysis and Coordination.
These initiatives address the difficulties clinical researchers confront in satisfying the multiple require ments of diverse regulatory and policy agencies. NIH is working to standardize reporting requirements and streamline policies.
Translational Research. Initiatives in this group are designed to accelerate the translation of research findings to patient care, partly by fostering the devel opment of a new discipline of clinical and translational science that will be broader and deeper than the cur rent separate domains of translational research and clinical investigation.
See http://nihroadmap.nih.gov/ for more information on the NIH Roadmap initiatives.

Research Teams of the Future
The following initiatives within this theme are designed to encourage scientists and scientific institutions to test a variety of models for conducting research.

High-Risk Research. The NIH Director's Pioneer
Award program is designed to support individual researchers with innovative approaches to major challenges in biomedical research.

Interdisciplinary Research.
A series of awards will be established to make it easier for scientists to con duct interdisciplinary research. Other initiatives are designed to change NIH policies and procedures. For example, rather than recognizing only a single Principal Investigator (PI) for every award, NIH is moving toward recognition of multiple PIs for any award.
Public-Private Partnerships. Initiatives are promoting and facilitating partnerships among researchers in academia, the Government, and the private sector.
-Lori Wolfgang Kantor, M.A. Science Editor for Alcohol Research & Health