'NIH Roadmap for Medical Research’ Released
On September 30, National Institutes of Health (NIH) Director Elias Zerhouni rolled out the “NIH Roadmap for Medical Research,” a series of “bold” initiatives designed to transform medical research capabilities and speed the movement of research from the laboratory bench to the patient’s bedside. The “Roadmap” is the culmination of a series of meetings Zerhouni convened soon after taking the helm of the NIH in May 2002. (See Update, May 13, 2002).
According to Zerhouni, the purpose of the Roadmap exercise was to identify major opportunities and gaps in biomedical and behavioral research that no one institute at NIH could undertake single-handedly, but are still part of the agency’s mission. The agency expects to spend $128 million in FY 2004 on Roadmap initiatives and more than $2 billion overall by FY 2009. (The NIH’s total budget in FY 2003 was $27.2 billion.) The funding for the Roadmap will come from a common pool of resources that will be used for all current and future investments.
Highlighting “remarkable progress in medical research,” Zerhouni related that “NIH-supported research has changed the landscape of many diseases.” The NIH needs “to change, adapt, and be innovative to take advantage of the opportunities” that are available as a result of the doubling of the agency’s budget, Zerhouni emphasized. “NIH is now drawing all fields of science together in a concerted effort to meet these challenges head on,” he added.
The agency’s Roadmap was developed with input from nationally recognized leaders in academia, industry, government, and the public. Designed to provide a framework for the strategic investments that NIH needs to make to optimize its entire research portfolio, the roadmap builds on the momentum provided as a result of the recent doubling of the NIH budget.
The plan is responsive to the recommendations within the recently released National Academies report, Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges, the result of a Congressional request. That report recommended the NIH director present the scientific rationale for trans-NIH budgeting and the creation of a “discrete program” in the Office of the Director “to fund the initiation of high-risk, exceptionally innovative research projects offering high potential payoff,” both of which the Roadmap seems to set in motion.
The Roadmap’s structure is comprised of 28 initiatives and focuses on three main areas: 1) new pathways to discovery, 2) research teams of the future, and 3) re-engineering the clinical research enterprise.
According to Zerhouni, only scientific initiatives “deemed of high potential impact,” sufficient to enhance the disease and mission-specific activities of all of NIH’s 27 institutes and centers (ICs), and that will respond to the needs and concerns of the public are part of the Roadmap. Implementation of the plan will begin in FY 2004. He explained that some of the initiatives selected build upon existing research and are “expected to achieve their goals rapidly” while more complex initiatives are expected to take several years to complete. “Through these new initiatives, we hope to remove some of the biggest roadblocks that are keeping research findings from reaching the public as swiftly as possible,” Zerhouni observed. The efforts cover a broad spectrum of points between the laboratory and the clinic, he explained.
Research Teams of the Future
The NIH Roadmap acknowledges that the traditional divisions within biomedical and behavioral research may inadvertently impede the pace of scientific discovery. To combat these “artificial organizational barriers,” the Roadmap includes the establishment of a series of awards designed to make it easier for scientists to conduct interdisciplinary research. The new awards will provide funding for:
§ Training of scientists in interdisciplinary strategies
§ Creation of specialized centers to help scientists forge new and more advanced disciplines from existing ones; and
§ Initiation of forward-looking conferences to catalyze collaboration among the life and physical sciences.
Interdisciplinary research is defined as “integrating the analytical strengths of two or more often disparate scientific disciplines to solve a given biological problem.” The Roadmap cites as an example: “behavioral scientists, molecular biologists, and mathematicians might combine their research tools, approaches, and technologies to more powerfully solve the puzzles of complex health problems such as pain and obesity.” Such research will allow for the eventual elimination of the traditional gaps in terminology, approach, and methodology. It is hoped that the establishment of these new awards will accelerate research on diseases of interest to all 27 ICs.
The current plan is to issue the first awards in FY 2004 with the creation of 15 planning grants for interdisciplinary research centers. Additional RFAs will also be issued in FY 2004 to provide training to scientists.
As part of the effort to lower the barriers that have impeded interdisciplinary studies, the new awards will grant principal investigator status to all key members of the research team; provide indirect research costs to multiple institutions involved in the research; require integrated reviews of grants, which take into account the melding of the various disciplines; and encourage interdisciplinary teams to evolve in both directed and serendipitous ways.
Exploratory Centers for Interdisciplinary Research RFA
To this end, the NIH has released the Exploratory Centers for Interdisciplinary Research RFA (RFA-RR-04-002). In recognition of the need to bring several disciplines together as equal partners, the RFA allows the research teams to submit separate, but related applications that will be reviewed as a unit. The 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 time line. A letter of intent is due by January 30, 2004 and the application receipt date is February 24, 2004. For more information contact: Greg Farber (301/435-3563 or firstname.lastname@example.org) or Michael F. Huerta (301/443-3563 or email@example.com)
Other initiatives incorporated under the research teams of the future include:
§ Interdisciplinary Research (IR) Centers – Planning grants to begin IR programs that will address significant and complex biomedical problems, particularly those that have been resistant to more traditional approaches will be awarded.
§ Interdisciplinary Research Training Initiative – As IR centers will likely cross the borders of two or more NIH ICs, this initiative will allow each IC to support wholly components of a consortium that are relevant to its mission, even when the preponderance of research in a given consortia effort does not.
§ Innovations in Interdisciplinary Technology and Methods (meetings) – The goal of these initiatives is to facilitate interdisciplinary research, which includes the behavioral and social sciences, by developing and improving methods and measurement.
§ Removing Structural Barriers to Interdisciplinary Research – Designed to help NIH remove business practice barriers that impede IR, including recognizing more than one principal investigator.
This section of the Roadmap also includes the creation of the NIH Director’s Innovator Awards. These awards are nothing like the NIH has ever done before. The awards will provide support ($500,000 per year for five years) to “a highly select group of individuals who have the potential to make extraordinary contributions to medical research. They will be evaluated in terms of their exceptional creative abilities, potential for ground-breaking discovery, evidence of focused and skillful habits of mind that predict perseverance and thorough exploration of his/her ideas, and prospects for making seminal biomedical research advances.”
New Pathways to Discovery
In an attempt to address the need to advance the understanding of the complex biological systems, this theme is designed to build “a better ‘toolbox’ for researchers. This includes an initiative to create “National Centers for Biomedical Computing (NCBC).”
Accordingly, the NIH has released a National Centers for Biomedical Computing RFA (RFA-RR-04-001) designed to create a networked national effort to build the computational infrastructure for biomedical computing, the National Program of Excellence in Biomedical Computing (NPEBC). The NCBC will be devoted to all facets of biomedical computing, from basic research in computational science to providing the tools and resources that biomedical and behavioral researchers need to do their work.
The NCBCs are designed to bring together three types of scientists: 1) computational scientists, 2) biomedical computational scientists, and 3) experimental and clinical biomedical and behavioral researchers, who generate data that can be transformed into knowledge by computational simulation, analysis, modeling, data mining, and visualization.
After the funding of the initial NCBCs, NIH anticipates releasing a new program announcement that will support partnerships between individual investigators and the centers. Or individual investigators could be a part of a Driving Biological Project (DBP) funded within a NCBC.
The RFA uses the NIH U54 award mechanism: applicants will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is September 15, 2004. It is expected that this RFA will be reissued at least once to allow funded centers to have the chance for a competing continuation. The initial period of support for a U54 center will be five years. No center will receive more than 10 years total of NIH funding. For more information see: http://grants1.nih.gov/grants/guide/rfa-files/RFA-RR-04-001.
Re-engineering the Clinical Research
According to Zerhouni, it will be necessary to “recast” the entire system of clinical research. The “core” of the re-engineering of clinical research theme is recognition of the “need to develop new partnerships of research with organized patient communities, community-based physicians, and academic researchers.” A major goal of this initiative is to “more fully involve and empower the public in the research process.”
To learn more about the NIH Roadmap, please visit http://nihroadmap.nih.gov.