Tufts CSDD: March 12, 2013
More than half of all clinical trials worldwide that are regulated by the U.S. Food and Drug Administration (FDA) were conducted by independent, community-based principal investigators, as opposed to universities, hospitals, and government clinics, with the number of active principal investigations reaching a record high, according to a newly completed analysis from the Tufts Center for the Study of Drug Development.
Whereas the proportion of community-based investigators worldwide has grown, site performance has been exceedingly variable due, in part, to the limited experience and scale established by sites outside North America, according to Tufts CSDD.
“The investigative site landscape remains highly fragmented, with declining numbers of experienced professionals and limited infrastructure,” said Ken Getz, associate professor and director of sponsored research at Tufts CSDD. “The landscape is also less stable, as turnover rates remain high, particularly in regions outside North America.”
He said that high turnover rates- partly a function of onerous regulatory requirements, a challenging operating environment, and companies scaling back their global development programs- contribute to high site selection and management costs. Read more