CLINICAL RESEARCH AT NIH: WHERE DO WE GO FROM HERE?

Michael Gottesman

For the past 50 years, since the opening of the Clinical Center in 1953, the NIH intramural program has been a leader in applying basic biology to the understanding and treatment of human disease.

Landmark contributions—including the design and implantation of the first artificial heart valve, successful multidrug chemotherapy of cancer, use of lithium to treat manic-depressive mental illness and fluoride to prevent cavities, virtual eradication of hepatitis from the nation’s blood supply, and the first effective treatment of AIDS—have lengthened and improved the quality of millions of lives and saved billions of dollars in health-care costs.

The nation continues to invest in the promise of NIH research, strongly supporting our research budget and the construction of the new Mark O. Hatfield Clinical Research Center at a time when it is becoming increasingly difficult to conduct clinical research in our academic medical centers.

What must we do to ensure that NIH continues to provide the greatest return on this investment through innovative clinical research?

Clinical research at NIH has been the subject of several reviews over the last decade. Ten years ago, the Marks-Cassell report addressed the importance of revitalizing the physical infrastructure for clinical research and recommended the phased renovation of the Clinical Center. The first step in that process—new construction of a Clinical Research Center, including a new hospital and some associated laboratories—is on schedule for completion in 2004. The timeline for future renovations in Building 10 is still under consideration.

In 1996, the Smits report recommended development of a new system for governance of the Clinical Center hospital—and the Clinical Center Board of Governors was born, followed by a novel funding system based on a school tax on all contributing Institutes and Centers.

Because of continuing concerns about declining utilization of the Clinical Center, attributed in part to reduced recruitment and retention of clinical investigators, the Straus committee report in 1997 (see "Clinical Research Turns Over a New Leaf," The NIH Catalyst, May-June 1997, and "Clinical Research Action Plan," September-October 1997) initiated changes in salary support and career development of clinical investigators. These actions resulted in increased recruitment and improved retention of clinical investigators and more active clinical protocols.

The NIH Director’s Clinical Research Panel, although focused more on the plight of extramural clinical research, did support an important role for the intramural program in training clinical investigators. It suggested the development of what has become the highly successful Clinical Research Training Program for medical students.

A retreat in March, co-chaired by Allen Spiegel and myself and including the NIH leadership and many clinical investigators, explored recent successes and continuing problems in the intramural clinical research program (see "The Agony and the Ecstasy: Clinical Research at NIH").

Dr. Zerhouni challenged the participants to develop plans to optimize use of the Clinical Research Center and other NIH clinical research resources—and to build on our proud history of research contributions that have improved the health of the nation.

At the end of the meeting, I made several general observations, which can be summarized as follows:

The level of energy, enthusiasm, and passion of NIH clinical investigators remains high. Our clinical investigators and leadership care deeply about the important role that intramural clinical research can play in the overall NIH-supported clinical research program.

NIH should continue to study diseases of public health importance for which good treatments are not available (obesity and SARS are two examples).

We need to study disorders that disproportionately affect populations that are currently underserved, including minority populations and patients with rare diseases.

It is essential to follow up on the retreat with a series of panels and working groups to develop specific plans.

As a result of continuing discussions with the Clinical Center Research Steering Committee, the NIH director, and the IC directors, the following actions will be taken over the next few months.

First, a Blue Ribbon Panel, including renowned non-NIH clinical and translational researchers and senior NIH clinical research leadership, will be established to answer these questions: "What kinds of clinical research should be done at NIH?" and "How can we best evaluate the success of our clinical research program?"

Next, a new working group on recruitment and career development of clinical trainees and investigators will be established. Its goal will be to continue to improve the working environment and the status of clinical investigators at NIH. Once research priorities have been established, the director of the Clinical Center and I will chair a working group to advise on assignment of resources needed to initiate and maintain the most effective and innovative clinical research programs.

Finally, we will continue to work with the appropriate agencies and organizations, both at and outside of NIH, to reduce unnecessary bureaucratic burdens on the clinical research process, always mindful of the primary requirement to protect human research subjects.

This ongoing process cannot succeed without the ideas and cooperation of NIH staff at all levels. Please continue to send me your thoughts and comments.

—Michael Gottesman
Deputy Director for Intramural Research

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