Research Updates in Kidney and Urologic Health

NIDDK Researchers to Explore Pathways on NIH Roadmap

In September 2003, Director of the National Institutes of Health (NIH) Elias A. Zerhouni, M.D., unveiled a series of far-reaching initiatives known collectively as the NIH Roadmap for Medical Research. The NIH Roadmap is an integrated vision to deepen our understanding of biology, stimulate interdisciplinary research teams, and reshape clinical research to accelerate medical discovery and improve people's health. Following this plan will lead to a more efficient and productive system of medical research.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will join all NIH institutes and centers in promoting three Roadmap themes:

• New Pathways to Discovery
• Research Teams of the Future
• Re-engineering the Clinical Research Enterprise

NIDDK will participate in all of these agency-wide programs designed to develop new technologies and foster new approaches to the puzzles of health and disease.

NIDDK encourages researchers to pursue the funding opportunities that will emerge as more NIH Roadmap programs are announced. NIH has already issued several requests for applications (RFAs) for programs that promote the NIH Roadmap themes. The programs described here demonstrate how NIH intends to keep pace with the health demands of the 21st century.

New Pathways to Discovery

Better instruments lead to better understanding of the many interconnected networks of molecules that make up our cells and tissues and regulate their interactions. Scientific tools developed in the past decade are providing many pieces of information that have yet to be fully understood. To make the most of the recent completion of the human genome sequence and many recent discoveries in molecular and cell biology, the research community needs increased access to technologies, databases, and other scientific resources that are more sensitive, more robust, and more easily adaptable to researchers' individual needs.

One of the first NIH-wide programs designated to support this Roadmap theme is Metabolomics Technology Development (RFA-RM-04-002), a program to encourage the development of highly innovative and sensitive tools for identifying and quantifying cellular metabolites and their fluxes at high anatomical, spatial, and temporal resolution. Originally proposed as an NIDDK initiative, the Metabolomics program will invite researchers from all medical disciplines and research fields. Although the issues of metabolism are most closely associated with diabetes and digestive diseases, the technologies developed under this initiative will play a major role in transferring capabilities to laboratories and research institutes that are investigating the underlying pathways involved in cellular homeostasis, perturbation, development, and aging. Metabolomics and other initiatives for New Pathways to Discovery will provide a solid scientific foundation for new strategies for diagnosing, treating, and preventing disease.

Research Teams of the Future

The scale and complexity of today's biomedical research problems increasingly demand that scientists move beyond the confines of their own disciplines and explore new organizational models for team science. For example, imaging research often requires radiologists, physicists, cell biologists, and computer programmers to work together on integrated teams. Many scientists will continue to pursue individual research projects; however, they will be encouraged to change the way they approach the scientific enterprise. NIH wants to stimulate new ways of combining skills and disciplines in both the physical and the biological sciences. The Director's Innovator Award will encourage investigators to take on creative, unexplored avenues of research that carry a relatively high potential for failure but also possess a greater chance for truly groundbreaking discoveries. In addition, novel partnerships, such as those between the public and private sectors, will be encouraged to accelerate the movement of scientific discoveries from the bench to the bedside.

As part of the Research Teams of the Future theme, the NIH has issued the RFA Exploratory Centers for Interdisciplinary Research (RFA-RM-04-004). This RFA invites applications for planning grants using the P20 (exploratory center) mechanism that will focus on developing new approaches to solving significant and complex biomedical problems, particularly those that have eluded more traditional approaches. These new approaches must hold the promise of leading to new research that improves human health.

These planning grants are expected to identify a biomedically relevant problem, evaluate why previous approaches have not worked, justify why the proposed interdisciplinary approach will work, identify the planning approach, and propose a timeline. The planning approach could include holding workshops or conducting feasibility studies, but these are only examples of possible planning approaches. Success is defined as combining aspects of individual disciplines to provide a new approach to solving a problem that could not have been achieved by an isolated laboratory. The planning grant should request 3 years of funding.

Re-engineering the Clinical Research Enterprise

Ideally, basic research discoveries are quickly transformed into drugs, treatments, or methods for prevention. Such translation lies at the very heart of NIH's mission. Although NIH historically has funded medical research that has helped to transform once acute and lethal diseases into more chronic ones, it has become clear to the scientific community that our country needs to recast its entire system of clinical research to remain as successful as in the past.

Over the years, clinical research that helps discover mechanisms of disease, prevention, diagnosis, or treatment has become more difficult to conduct. Yet the exciting discoveries we are currently making require us to conduct even more efficiently the complex clinical studies required to make rapid medical progress and to further inform our basic science efforts. This is undoubtedly the most challenging but critically important area identified through the NIH Roadmap process.

At the core of this vision is the need to develop new research partnerships with organized patient communities, community-based physicians, and academic researchers. This also includes the need to build better-integrated networks of academic centers linked to a qualified body of community-based physicians who care for sufficiently large groups of patients interested in working with researchers to quickly develop and test new interventions. This vision will require new paradigms in how clinical research information is recorded, new standards for clinical research protocols, modern information technology platforms for research, new models of cooperation between NIH and patient advocates, and new strategies to re-energize our clinical research workforce.

Re-engineering the Clinical Research Enterprise is intended to address these pressing needs by promoting the better integration of existing clinical research networks, encouraging the development of technologies to improve the assessment of clinical outcomes, harmonizing regulatory processes, and enhancing training for clinical researchers. A major goal of this initiative is to more fully involve and empower the public in the research process.

One of the first NIH initiatives to promote this Roadmap theme is the Multidisciplinary Clinical Research Career Development Program (RFA-RM-04-006), which is designed to support the early career development of clinical researchers from a variety of disciplines engaged in all types of clinical research, including patient-oriented research, translational research, small- and large-scale clinical investigation and trials, and epidemiologic and natural history studies. These individuals would be expected to achieve excellence in their ability to design and oversee research in multidisciplinary team settings and have a high potential to become leaders of various fields of clinical research critical to the overall mission of NIH.

The program will train and foster the career development of individuals with doctoral-level professional degrees to become the next generation of clinical researchers who will perform clinical investigation in multidisciplinary, collaborative clinical research settings. Career development programs supported under this RFA must include a broad representation of clinical disciplines and professions (e.g., internal medicine, surgery, pediatrics, obstetrics/gynecology, dentistry, pharmacy, statistics, nursing, psychology) and their various specialties and sub-specialties. Programs must include a structured core didactic component and a practical training component in various aspects of the design, conduct, and analysis of clinical research. Individuals should be trained in team research settings and will be known as NIH Clinical Research Scholars (CR Scholars).

Taken together, the components of these initiatives are part of a well-thought-out national portfolio of research to stimulate innovation and collaboration. NIDDK is committed to supporting those goals. More information about the NIH Roadmap can be found at http://nihroadmap.nih.gov. Further information about the NIH can be found at its website: www.nih.gov.

NIH Publication No. 04–4531
May 2004