In countries outside the U.S., principal investigators who elect not to do any more trials are usually the nervous newbies. That’s not a shock. What is surprising is that here in the U.S., those leaving clinical research, never to return, are—ouch—the seasoned veterans. 

That’s according to Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development (CSDD), who regaled the crowd at the 2007 Drug Information Association (DIA) conference last month with worrisome statistics about the clinical investigator landscape. 

High turnover among experienced U.S. investigators is one of the more shocking trends he’s been keeping an eye on. This clearly does not bode well for the world of research, said Getz.

More Cost to Sponsors

“This suggests sponsors have a lot more work ahead of them to create a seasoned pool of investigators,” he said. “This means higher costs for sponsors, and more noncompliance.”

What’s driving veteran investigators away? “They find [conducting a trial] is much more burdensome today,” Getz explained. “The labor intensity to support a given protocol is much higher now. Regulatory requirements are much higher and financial attractiveness has really diminished over the years. [Experienced investigators] just can’t justify it anymore.”

Burdens = Mistakes

And with those added burdens come more mistakes. Reported Getz, the number of complaints filed with the FDA against investigators has been increasing sharply each year since 2003, with 354 complaints filed last year.

Said Getz, “The burden of clinical research for the site has become so onerous that for a variety of reasons, they are pressured to try to do their work faster, which might result in the perception that they are becoming less compliant.”

Getz added that the vast majority of complaints result in minor action or no action at all. Nevertheless, the increase is concerning. The Tufts Center is in talks with the FDA to get more details on these complaints in order to better understand exactly what’s going wrong at the site level.

Neither Up Nor Down

According to Tufts numbers, each year turnover among P.I.‘s is getting worse. In 1990, 27 percent of them left the field and didn’t return. Ten years later, that number had risen to 36 percent.

The investigator landscape is becoming increasingly global, said Getz. Tufts numbers showed that, thus far thus year, 57 percent of investigators are based in the U.S., while 14 percent are in Western Europe and 29 percent are rest-of-world. The number of investigators in the U.S. has been dropping steadily since Tufts began collecting numbers in 1997. Getz added that a surprising 40 percent of all FDA-regulated trials are now being done abroad.

White Males, Age 50

The vast majority of investigators—more than 80 percent—are white males, age 50 on average. MDs constitute 93 percent of investigators; the rest are PhDs. Fifty-seven percent are based in urban areas, 31 percent suburban and the rest rural. Overall, 38 percent of investigators who had previously conducted a trial did not elect to do another. Getz says that in the last 10 years, drop out rates among P.I.‘s have almost doubled.

Bright Spot

In an interview with ClinPage after DIA, Getz said that amid all this ominous news about investigators, there are a few bright spots.

He is heartened, for example, by the trend of small, private-practice investigators pooling their resources with other like-minded sites/investigators to hire a small central staff that takes care of tasks such as accounting for trials. “It’s a creative approach that gives the investigator more leverage,” said Getz. Sponsors like such an approach because they’re dealing with the doctor directly.

—by Suz Redfearn