The NIH Roadmap: A Perspective for the Hematology Community

By Barbara Alving, M.D.
Dr. Alving is the Acting Director of the National Heart, Lung, and Blood Institute

Soon after becoming the Director of the National Institutes of Health (NIH), Dr. Elias Zerhouni began to address core issues related to the national research enterprise. Recognizing that essential functions of the NIH are to accelerate the rate of discoveries in the life sciences, speed the translation from laboratories to patients and again back to laboratories, and to ensure that the results of clinical research are incorporated into the practice of medicine, Dr. Zerhouni initiated extensive discussions with more than 300 national leaders in industry, academic medicine, government, and the public. As a result of these discussions, the NIH developed a Roadmap that begins in 2004 and extends through 2009. The Roadmap is in evolution; however, three key areas have been identified, and initiatives that can apply to all research communities are being developed in a collaborative fashion by the NIH Institutes and Centers. The three major areas of the NIH Roadmap are New Pathways of Discovery, the Development of Research Teams of the Future, and Re-engineering the Clinical Research Enterprise.

New Pathways of Discovery will include the development of screening centers where libraries of small molecules can be registered; chemical genomics centers, one of which will be at NIH; chemiinformatics computing centers; and an intramural facility to produce imaging probes. Other centers to be developed are those for nanomedicine and membrane protein production. The intellectual property and products from these centers will be in the public domain.

Recognizing that the rapid advancement of science now requires interaction of investigators from multiple disciplines and that teams require unique resources, the Roadmap will emphasize the Development of Research Teams of the Future. The Roadmap will facilitate interactions among scientists of diverse training, since effective teams may require professionals with expertise in bioinformatics and bioengineering, as well as those with expertise in medicine and the life sciences. In order to facilitate team building, the NIH is developing initiatives for the formation of exploratory centers for interdisciplinary research. The promotion of public-private partnerships will also be explored. The NIH Director's Pioneer Awards will be established to promote high-risk research (each recipient will receive $500,000 per year for five years).

Re-engineering the Clinical Research Enterprise is a major effort that is focused on improving training for clinical investigators, including those in community-based hospitals and outpatient settings, and developing linkage among clinical research networks that can interact and address multiple clinical research questions. The networks can also provide a foundation for a National Clinical Research Associates Program, which will provide training in clinical research. Another endeavor in the re-engineering process will be the development of a National Electronic Clinical Trials and Research (NECTAR) network. A first goal in this initiative is to develop an inventory of all the clinical research networks and to examine characteristics that can define best practices in the management of clinical trials. Areas to be evaluated include the use of informatics and the training of investigators. Clinical Research Policy Analysis and Coordinated Programs will be developed which will coordinate clinical research requirements, such as adverse event reporting, best practices in informed consent, and the understanding of privacy requirements and HIPAA regulations in clinical research.

Although the goals of the Roadmap are ambitious, the funding represents only a small part of the NIH budget. All Institutes and Centers are committed to pooling their resources to support the Roadmap initiatives through 2009. The investment in the Roadmap for 2004 is $128 million (the total NIH budget for 2004 is $28 billion, so this less than 0.5% of the total budget). The cumulative cost for the Roadmap through 2009 is expected to be approximately $2.2 billion.

The Roadmap initiatives are applicable to all research communities. It is now time for clinical and basic research investigators to become extremely familiar with the initiatives that are posted (www.nihroadmap.nih.gov) in order to determine how they can best participate. Questions will arise, and each Institute is prepared to provide guidance needed to ensure the participation of the research communities in this endeavor. The Roadmap, like all roadmaps, is a work in progress. Nothing of this scope has been previously developed by the NIH. Its success requires full involvement of all communities, who also have the potential to shape future directions. The leaders of the hematology community were involved in the discussions which led to the formation of the Roadmap, and the hematology community is one which will benefit greatly from full participation in its ongoing development.

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