Translating Biomedical Research to the Bedside: Title and subTitle BreakA National Crisis and a Call to Action

The doubling of the National Institutes of Health (NIH) budget in recent years,^{1 - 2} the publication of the initial sequence and analysis of the human genome in 2001,^{3 - 4} and advances in molecular biology, neuroscience, immunology, biomedical engineering, and functional magnetic resonance imaging suggest that these remarkable achievements in clinical and basic science research are being successfully translated to the clinic and bedside. There is an assumption that the recent exponential growth of scientific information about disease, as evidenced by the substantial increase in the numbers of published articles in biomedical journals, heralds a rapid move to improve human health.

This illusion is the subject of an intense analysis begun in June 2000 by the Clinical Research Roundtable (CRR) at the Institute of Medicine, as reported in this issue of THE JOURNAL by Sung et al.⁵ The CRR represents a group of stakeholders in the nation's clinical research enterprise who have met frequently and have dissected and debated the issues of health care delivery from discoveries made in the research laboratories of US universities and research institutes. The group concludes, however, that a significant increase in resources must now be deployed to develop the mechanisms and infrastructure to accomplish the translation and implementation of this new knowledge to the patient. They point out a "disconnection between the promise of basic science and the delivery of better health."⁵ Unless bold and creative new strategies are enacted by the president and US Congress, the "data and information produced by the basic science enterprise will not result in a tangible public benefit."⁵

The CRR report indicates that the battle for fast-tracking clinical research to the bedside is being lost. The identified blocks in the translation of new knowledge into clinical practice and from basic science to human studies are due to high research costs, career disincentives, slow results, lack of funding (especially for clinical research), regulatory burdens, fragmented infrastructure, incompatible databases, a shortage of qualified investigators and willing participants, and practice limitations. It is a cause of great concern that despite a substantial investment by the NIH in research, support for basic research far outweighs that for clinical research. The CRR points out that the funding success rate of clinical research proposals is about half that of basic science proposals.⁵ Addressing and reversing each "translational block" is the obvious answer, but going from theory to results in practical terms is far more daunting. Today, more than $25 billion is spent on biomedical research annually, instant communication occurs throughout the biomedical community via high-speed computers, more than 100 major universities are conducting biomedical research, and more than 10 000 new grants are funded annually by the NIH alone to highly motivated and talented investigators.^{1 - 2} The CRR acknowledges all of these attributes and yet concludes that it may take many years, even a decade or more, for promising research to go from the bench to the bedside. So what can be done about it right now?

The members of the CRR should have been less systematic and more declarative and passionate about expressing new ideas. Their report reads like a committee's thoughts, which is exactly what it is. Recently, Congress approved and the president signed into law the implementation of a new Department of Homeland Security at the cabinet level in response to a national emergency, the tragedy of September 11, 2001, and international terrorism.⁶ According to the criteria listed in the CRR report, an analogous national emergency now exists that may affect millions of patients, as effective and promising research is being delayed due to a national lack of coordination and even resolve. Lives are literally being lost daily because of inertia in the system to move promising research quickly enough to the patient in need.

It is not likely that a new Department of Biomedical Research will be established at the cabinet level of our government to address the findings of the CRR report. Sometimes, however, the right person with an effective action makes a strategic difference. There are precedents. Albert Einstein wrote a single short letter to Franklin Roosevelt warning about the new field of nuclear energy and the need to act to develop a national program in this area before it was too late. Its effect was immediate and precipitated the effective Manhattan Project.⁷

Publishing the report by the CRR is necessary and appropriate but not sufficient to mobilize national sentiment and resolve. A unified voice from the biomedical community must speak clearly and resolutely to emphasize that the CRR report amounts to a national crisis. The American people need to know that the current system for bringing promising biomedical research to the bedside is operating at an obsolete level of efficiency, causing great delay, and consequently resulting in the loss of many lives.

An independent group, composed of the nation's most prestigious investigators and clinicians, should alert the president and leaders of Congress about this major health problem. A single short letter should point out the human consequences due to the present inefficient system of translating information from the laboratory to the bedside, request a meeting, and ask for the resources and authority to design a whole new system and approach. The inertia and inefficiency of the flow of scientific information from research laboratories to clinical trials, through the governmental approvals process, and, finally, to patients, as described in the CRR report, is a national crisis of major proportions. A clarion call to action no different in scope than that described by Einstein and no less needed than the response to September 11 is required to save lives.