One of the first priorities for Tom Daschle, President-elect Barack Obama’s choice as US Secretary of Health and Human Services, should be to tackle the “crisis” in US clinical research, argues the American Federation for Medical Research (AFMR).

The clinical research environment has “weakened significantly” under the Bush administration and improving it is “a lynchpin to achieving sustainable change in the US healthcare system”, the AFMR contends. Daschle has “the opportunity to fix this fundamental issue early on”, which will have “an enormous ripple effect” on healthcare in general, it claims.

According to the AFMR, clinical research is undernourished in the US for two principal reasons: cuts in federal funding for the National Institutes of Health (NIH), and particularly in the money spent on clinical research as well as the education and training of future clinical investigators and physician-scientists; and lack of support for prospective physician-scientists, “whose job it will be to bring modern medicine and quality patient care to future generations”.

While Centers for Disease Control and Prevention data show that chronic diseases account for seven out of 10 deaths in the US and for 75% of every annual healthcare dollar spent, federal funding for clinical research has been on the wane in recent years, the AFMR points out. What money has been apportioned goes mainly on basic rather than clinical research, the latter representing “the only kind of research that generates disease-specific breakthroughs and patient treatment alternatives”.

The NIH budget for the current fiscal year is US$29.2 billion, a rise of US$329 million over last year. However, the actual growth in NIH programme spending “is much less because US$200 million of the increase was earmarked for the Department of State Global HIV/AIDS fund”, the AFMR observes. Taking away US$200 million gives a year-on-year increase of US$133 million or just 0.5%.

“It is not yet known how the FY 2009 budget will be impacted, although the statement accompanying the signed bill from President Bush indicated his intention to submit an FY 2008 budget proposal that will ‘once again restrain spending’,” the Federation adds.

Translational gap

One area affected by this belt-tightening is the Clinical Translational Science Award (CTSA) initiative, an NIH-supported clinical research programme that aims to speed up the translation of scientific discoveries into viable treatments. The budget cuts mean the NIH is unable to fund fully the evolution and expansion of the CTSA programme, “which has become a critical training and research structure for junior investigators”, says the AFMR.

Another “alarming issue” is the growing scarcity of human resources in the clinical research field, it notes: “The current generation of physician investigators is aging rapidly and there aren’t enough investigators to replace them because support for new investigators entering the field has decreased significantly in recent years.”

According to the NIH, the average age of physician scientists was 39 years in 1980; by 2015, it is expected to be 52 years. “If action is not taken now, the US will face a critical shortage of qualified physician investigators within the next decade, creating a massive knowledge gap between aging physicians and the next generation of physicians,” the AFMR warns.

"The cost of not advancing research and training future physician scientists is one that will be paid by the entire world,” comments the Federation’s president, Dr Alan Buchman.

“The United States is a global feeder pool of physician scientists. A further breakdown in clinical research and failure to revitalise the physician-scientist workforce of the future will impact medical breakthroughs, treatments and critical training throughout the world. The pharmaceutical industry cannot be counted on to undertake clinical research alone, and from an economic standpoint, clinical research dollars are being focused away from the US and concentrated on China and India.”

Based in Boston, the AFMR is an international, multi-disciplinary association of physician scientists engaged in all areas of patient-oriented clinical, translational and laboratory research.