The number of principal investigators (P.I.s) filing 1572s worldwide has declined sharply, according to new data from the Tufts Center for the Study of Drug Development (CSDD).
After spending most of the past decade at a fairly stable level, topping out at 27,861 in 2008, the number of active, unique P.I.s filing FDA form 1572s dropped precipitously to 23,935 in 2009. In 2010, the number continued its downward trend, with an estimated total at 22,243.
But while there was an 11% decrease in the number of P.I.s starting new studies globally, there was a more dramatic 20% drop in the number of active P.I.s in the U.S. In 2008, there were 15,213. But by 2009, that number had plunged to 11,971.
In Canada in 2008, there were 1,021 P.Is. In 2009, that fell to 729—a nearly 30% decline.
The average number of 1572s filed per investigator in the U.S. and Canada also dropped in 2009, to 1.9, after hovering between 2.2 and 2.3 from 2005 to 2008.
Ken Getz, senior research fellow at Tufts CSDD and founder/owner of CenterWatch, said these numbers, culled from the FDA’s Bioresearch Monitoring Information System File (BMIS), represent an “historic and sharp decline.” It’s a direct result of the downturn in the global economy that began hitting pharmaceutical companies—and most industries—in the fourth quarter of 2008.
“The level of decline in the number of new 1572s filed suggests that we’ve hit a drier period in terms of innovation activity,” he said. “The downturn in the global economy characterized by the lack of access to capital and softening consumer demand, combined with the high level of branded drug revenue soon to lose patent protection, has caused a lot of pharmaceutical and biotechnology companies to suspend projects and terminate work.”
CenterWatch recently reported that the number of clinical trials initiated after late 2008 dropped by 40%, so the decline in 1572s follows suit.
“What this means is that the drug development enterprise is doing less innovation at this time,” said Getz.
Before beginning participation in a clinical study, investigators must sign an FDA form 1572 pledging that he or she will abide by the federal guidelines set forth in the Code of Federal Regulations for the use of drugs in an investigational setting. The form provides a handy way to measure activity in the clinical investigative sector of the market, which was worth $8.4 billion in 2010.
The good news, though—an uptick is likely on the horizon.
“We don’t expect this to continue,” said Getz. “As the economy improves and the volume of R&D that we see now in non-clinical phases moves into clinical phases, we expect to see gradual increases in the number of P.I.s year over year.”
That uptick is likely to begin within the next three to five years, Getz said.