GAZING INTO THE CRYSTAL BALL:
NIH'S CLINICAL RESEARCH FUTURE, PART II

In the previous issue of The NIH Catalyst,we focused on our plans for strengthening clinical research. Much of our thinking about future changes and improvements in our clinical program has centered on adapting the physical environment and streamlining operations to fit the size, abilities, and interests of our clinical research staff. But a second key consideration in the future of the Clinical Center is our charge to train clinical investigators.

Virtually since its inception in 1953, the Clinical Center has embraced a mandate that extends beyond its mission as a research hospital: to define what physicians and scientists need to know to conduct safe, effective clinical research and to make that information available to the scientific community.

With those goals in mind, NIH Director Harold Varmus has encouraged the development of a major new training initiative at the Clinical Center, and work on a core curriculum is under way. The curriculum will comprise four modules, each containing both didactic lectures and practical experience, such as interacting with mock Institutional Review Boards (IRBs) and data safety-monitoring panels. The training initiative will proceed in the following manner:

• The first module will address clinical research methods and focus on epidemiology. It will include lectures on study design and development, measurements, and issues in alternative medicine.

• The second module will address ethical and regulatory issues, including legal concerns, the role of IRBs, sex and race diversity in study populations, and scientific conduct.

• The third module will cover patient-oriented research and will review quality assurance, how to monitor clinical trials, relations with the Food and Drug Administration, information and data management, and information dissemination.

• The final module will focus on preparing and funding a clinical research study, including writing a research proposal, and technology-transfer issues.

We must also make sure that our researchers are located in an ideal environment for training these Clinical Associates, and for conducting patient-oriented research. Clearly, the new hospital and reallocation of the Clinical Center's physical plant will have payoffs for our teaching efforts commensurate with their contribution to improving research. It is also imperative that the institutes work toward parity in the support of clinical researchers.

Some institutes have structured a superb network of computers, research nurses, and support staff to facilitate that training. Others have developed a less efficient framework. A goal of mine is to reduce this variance among institutes.

One step in that direction is to develop guidelines for training clinical researchers and for performing clinical research at the Clinical Center. The guidelines will provide criteria against which our educational tools -- including teaching, mentoring, assessment practices, and the research infrastructure of the various intramural programs -- can be judged. The guidelines will tell us what our training and clinical research programs should look like to produce high-quality clinical research and to train researchers capable of conducting that research.

These guidelines must be developed with broad NIH consensus and need to be flexible so that the different institutes can tailor intramural programs to individual needs. Eventually, such guidelines may evolve into a national yardstick for training in clinical research. I believe that such guidelines are needed and that they must be sharply honed and responsive to changing needs and requirements.

In sum, this is an exciting time for clinical research and the training of clinical investigators as NIH scientists continue their roles as the nation's premier scientists. We are committed to maintaining and expanding the Clinical Center as NIH's most valuable and most efficient scientific resource.

John I. Gallin, M.D.
Director
Warren Grant Magnuson Clinical Center
Associate Director for Clinical Research