Number of Principal Investigators in the U.S. Is Declining, According to Tufts Center for the Study of Drug Development

BOSTON - May 3, 2005 - Following steady growth through the 1990s, the number of principal investigators conducting industry-sponsored clinical studies in the United States has declined 11% since 2001, according to a study recently completed by the Tufts Center for the Study of Drug Development.

The drop in principal investigators has been spurred by a similar decline in the number of active clinical trials, the study found.

According to Tufts CSDD, a 10.6% decline in clinical trials has led to an 11.4% drop in total principal investigators in the U.S. between 2001 and 2003.

The study, the first of its kind to assess the principal investigator landscape, also found that turnover rates among principal investigators in the U.S. have nearly doubled since 2001, while regional and gender disparities among principal investigators have grown.

Tufts CSDD conducted extensive analyses of a database of more than 100,000 principal investigators who registered with the U.S. Food and Drug Administration to conduct clinical trials of investigational drugs between 1977 and 2004.

"The decline in the number of principal investigators and the high turnover rate pose several threats to research sponsors," noted Ken Getz, research fellow at Tufts CSDD and author of the study.

"The capacity of the market to conduct clinical trials for industry sponsors is eroding and efforts to establish a well trained, experienced pool of clinical investigators may become more difficult."

In addition, he said, growing gender and regional disparities among principal investigators will limit professional opportunities and potentially diminish scientific and economic benefits to declining regions. "This, in turn, could make it more difficult to recruit representative patient populations," said Getz.

Commenting on the significance of the study's findings, Tufts CSDD Director Kenneth I Kaitin said, "As the time, cost, and risk of new product development increases, pharmaceutical and biotech companies are looking to identify bottlenecks and improve efficiency of every facet of drug development. We believe this study will help them assess and improve their management of investigative sites."

The Tufts Center's analysis, summarized in the just-published May/June Tufts CSDD Impact Report, also found that:

• While the total number of principal investigators in the U.S. decreased from 2001 to 2003, their counterparts outside the U.S. increased by 8%.

• By 2000, half of all principal investigators in the U.S. chose never to conduct another clinical trial - nearly double the turnover rate observed 10 years before.

• The proportion of female-to-male principal investigators in the U.S. is steadily declining and is significantly below the overall ratio of female-to-male board certified physicians.

• Only 3% of all board certified physicians are principal investigators, and a growing percentage of principal investigators are migrating to the South region of the U.S.

About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development () at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. The Tufts Center, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.