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Front Page
FORUM

NIH Roadmap Aims to Speed Scientific Journey


Erica Seiguer
Photo by Graham Ramsay
The recent Roadmap from the National Institutes of Health, an initiative led by director Elias Zerhouni and released in September, defines a framework for the NIH to follow in making the U.S. system of biomedical research more efficient and productive. The guidelines recognize three main areas of "compelling opportunities": new pathways to discovery, future composition of research teams, and re-engineering of clinical research. The overhaul promises to influence basic-science and clinical training, as well.

Funding for the Roadmap will come from a common pool with contributions from the institutes and centers of the NIH. Zerhouni asserts that this mechanism and its multiyear structure is critical to the success of the initiative. "When you do something as game-changing and bold as the Roadmap," he said, "there is a clear need for sustainability. Often the size of a project makes it such that no single institute can tackle it alone--the budget may be larger than that of the largest Institute." He points out that the Roadmap is not a replacement for the investigations at individual institutes or centers, but will run "as a parallel track to what the institutes do, facilitating all research efforts."

Key Destinations

Within each area described in the Roadmap, a detailed plan outlines the major programs. In pathways to discovery, for example, one focus is biological pathways and networks. This includes the development of public molecular libraries that will provide access to small organic molecules as probes to study cellular pathways and their role in disease. Zerhouni emphasizes that this is not an effort to replicate efforts at pharmaceutical companies to screen compounds for drug development.

"Clinical research provides an opportunity to take a truly multidisciplinary approach, involving other segments of the University, including the Business School, Kennedy School of Government, and the Law School."

--Raphael Dolin

In the area of future composition of research teams, one emphasis is high-risk research--projects that have not yet received sufficient levels of funding from the NIH. The Roadmap explicitly recognizes this shortfall, claiming that the "peer-review process is oriented to fund so-called 'low-risk' proposals that advance well-established areas of science. This leaves many more speculative, or 'high-risk,' proposals without an obvious mechanism of NIH support." In an effort to attract such proposals, a new funding mechanism has been established in the Roadmap to support "high-impact" research projects.

Re-engineering the clinical research enterprise, the third area of opportunity, promises to have important implications for clinical research. According to the NIH plan, "implementing this vision will require new ways to organize the way clinical research information is recorded, new standards for clinical research protocols, modern information technology, new models of cooperation between NIH and patient advocacy alliances, and new strategies to re-energize the clinical research workforce."

Harold Varmus, director of the NIH from 1993 to 1999, and currently president and CEO of Memorial Sloan-Kettering Cancer Center in New York, believes that the Roadmap will help the NIH fulfill its aim to accelerate the pace of discovery and the application of new knowledge to improving health. Yet he is aware of the challenges presented by the increase in the number of institutes and centers, which he believes "undermines the capacity of the NIH director to manage the NIH and the ability of the NIH to take on the big, expensive, often transdisciplinary questions." He argues that there is a need to find ways to do more collaborative projects, in part by augmenting the authority of the NIH director.

Organizing Abundance

Raphael Dolin, dean for academic and clinical programs at HMS, sees the Roadmap as a response to the "explosion of new knowledge, particularly in terms of basic genetic and structural information: how best to link these activities to moving ahead with results that can be applied to patient care and how to do so most efficiently." Dolin describes the Roadmap as an initial step in a complex process that includes providing leadership with an appreciation of multidisciplinary teams with different backgrounds and orientations. It is this team approach that he sees as necessary for transforming the clinical research enterprise.

Dolin believes that improving the training of clinical researchers also is essential. HMS has several means of doing this, he says, including two master's degree programs, the Scholars in Clinical Science Program and the Clinical Investigator Training Program. Furthermore, the role of clinical research in medical training is part of the current discussions on curriculum reform at HMS. "If we are ultimately interested in controlling disease," Dolin said, "we need to consider economics; political issues; and regional, national, and international issues. Clinical research provides an opportunity to take a truly multidisciplinary approach, involving other segments of the University, including the Business School, Kennedy School of Government, and the Law School." While no formal structure has been established for this cross-school coordination, the University is working on how best to coordinate a complex and heterogeneous group of activities.

--Erica Seiguer, a fifth-year MD-PhD student studying economics in Harvard's Doctoral Program in Health Policy

Websites of Interest

NIH Roadmap
Harvard Clinical Research Institute