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National report — An apparent decline in the total numbers of U.S. principal investigators (PIs) and clinical trials could impact drug availability and, ultimately, the pharmaceutical industry's ability to innovate, according to a recent study.
Conducted by the Tufts University Center for the Study of Drug Development (CSDD), the report states that a 10.6 percent decline in clinical trials conducted stateside between 2001 and 2003 caused the ranks of U.S.-based PIs to dwindle 11.4 percent over the same period. Meanwhile, the number of investigators abroad increased by 8 percent.
Fewer drugs? "If there are declining numbers of pharmaceutical studies being performed, then one would think that in the next few years there will be declining numbers of new medications available to us," adds Joseph Fowler, M.D., clinical professor of dermatology at the University of Louisville, Ky. "And if there are fewer PIs doing these studies, then perhaps the reasons for that need to be explored. Perhaps drug companies are not developing as many new medications. Maybe it's the paperwork and regulatory work that must be done for drug studies. Some of that, perhaps, could be simplified. That would make it easier for all concerned."
Kenneth A. Getz, M.B.A., Tufts CSDD research fellow and author of the report says, "What's most intriguing about the entire analysis is not the fact that there's been a slight decline in the number of investigators, because we see that in cycles. It's the fact that we're seeing a larger percentage of investigators who are doing one study and not returning."
The study shows that the proportion of PIs who drop out of the U.S. Food and Drug Administration (FDA) 1572 submission process nearly doubled during the 1990s - from 27 percent in 1990 to 45 percent in 2000.
"What is it about clinical research that is not retaining PIs at levels that it used to?" Mr. Getz asks. "It (causes) a physician who is considering getting into clinical research to look at it long and hard. Is it an environment they're going to be comfortable operating under? The amount of rigor and regulatory requirements have grown, as have the financial challenges of managing a profitable research operation with good liquidity."
Demographic impact Demographic shifts within the population of U.S. PIs also could impact future research.
Specifically, the study found the average age of American PIs is increasing - from 43 years in 1992 to 50 in 2004. Conversely, the proportion of female PIs has dropped from about 15 percent in 1992 to 12 percent in 2003, although female physicians accounted for 28 percent of all board certified U.S. physicians in 2003. Declining ranks of female PIs could dampen recruitment of female patients, researchers say, possibly leading to less representative clinical data over time.