Study Finds Decline in Number of Clinical Trials, Lead Investigators

Pharmaceutical firms are conducting significantly fewer clinical trials than they were in the 1990s, a trend reflected by a rapid decline in the number of principal investigators (PIs) in the U.S. between 2001 and 2003, according to a study completed by the Tufts Center for the Study of Drug Development (CSDD).

The study, believed to be the first to assess the PI landscape, determined that the number of PIs in the U.S. decreased by 11.4 percent between 2001 and 2003. During that same period, the number of clinical trials dropped by 10.6 percent, the study says. In addition, turnover rate among PIs in the U.S. has nearly doubled since 2001, and regional and gender disparities have widened, according to Tufts CSDD.

"The decline in the number of principal investigators and the high turnover rate pose several threats to research sponsors," said 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 be more difficult."

Tufts CSDD based its findings on analyses of FDA data on more than 100,000 registered PIs who conducted clinical trials on investigational drugs between 1977 and 2004.