Number of clinical trials declining

The number of pharmaceutical industry-sponsored clinical trials has been declining since 2002, and the number of principal investigators running trials in the United States has been falling even faster, according to a study by the Tufts Center for the Study of Drug Development.

Using information from forms submitted to Food and Drug Administration (FDA) by principal investigators, researchers found that a "major expansion" of industry-sponsored research "levelled off" in 2000 and began declining after 2002. Study author Kenneth Getz, a research fellow at the Tufts CSDD, says the drop in research since 2002 is largely the result of cancellations of trials entering their final phase.

Furthermore:

The number of principal investigators leading clinical trials in the United States declined 11 per cent between 2000 and 2002, while the number of investigators working on FDA-approved trials abroad increased 8 per cent.

The number of principal investigators in the United States fell from 25,000 in 2001 to fewer than 21,000 in 2003.

Additionally, the number of U.S. sites where clinical trials were underway fell from about 51,000 in 2001 to 48,000 in 2003.

Getz says clinical trials increasingly are being performed abroad in areas where costs are lower, such as Eastern Europe, South America and India.

The southern United States, where costs are lower than in the north, experienced a 20 per cent increase in its proportion of U.S. clinical trials from 1994 to 2004.

The researchers also find that 12 per cent of clinical trial investigators are women, a lower percentage than in 1992.

Getz says that the big message here is that the decline in principal investigators is not solely a function of the short-term decline in clinical projects. If we continue to see this in the longer term, it could diminish the ability of pharmaceutical companies to innovate.

Source: Marc Kaufman, Clinical Trials of Drugs Fewer, Study Says; Report Also Notes Decline in Number of Principal Investigators in U.S., Washington Post, May 4, 2006.

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FMF Policy Bulletin 09 May 2006