As a result of today's competitive and rapidly changing economic arena, an increasing number of physicians outside academic centers are getting into the business of establishing investigator sites in which to conduct clinical trials for new drugs. And increasingly, pharmaceutical companies and clinical research organizations (CROs) are turning to the nonacademic clinical investigator to help them get new drugs approved and onto the market more quickly.
"There's most definitely a trend toward moving trials to independent settings," said Jane Ganter, editor in chief of Applied Clinical Trials. "Previously, most sites were in major teaching hospitals and universities, but with managed care making it more difficult for physicians to make a living, many started doing trials as part of their practices...and then formed companies."
Industry analyst Ken Getz, M.S., M.B.A., is founder and principle of CenterWatch, a Massachusetts-based publishing company that produces directories, a newsletter and a Web site <http://www.centerwatch.com> that lists international clinical trials and profiles of investigator sites for all areas of medicine, including psychiatry.
Getz said that in 1991, academic institutions were involved in more than 75% of all clinical trials placed by pharmaceutical companies and CROs. In 1996, the percentage dropped to less than half, or about 48%.
"The academic institution has been gradually losing its market share of projects because it's been a below-average performer," said Getz. "Typically, they tend to be more expensive, because their overhead rates are higher, and they're slower in enrolling patients and getting studies done than the smaller, privately owned site. So over time, pharmaceutical companies and CROs have asked themselves, where are the places we should be putting our studies when speed and cost are our most important criteria?"
And with the complexities of today's research, cost-effectiveness and efficiency of sites is more important than ever, he added.
"The drug development programs that companies are pursuing are much more complicated, and the diseases they're pursuing are also much more chronic, long-term illnesses. So it's much harder to find and keep patients in studies, and [there's] a lot more competition for patients as well."
Getz estimates that for all medical specialties combined, there are nationwide today about 12,000 investigator sites, 135 of which are major academic medical centers. And reflecting the percentage of physicians who are psychiatrists, from 650 to 800 of the national sites conduct psychiatric studies.
"Many sites are mom and pop," he said. "And then on the other side you have sites made up of more cutting-edge entrepreneurial physicians, and some of these are even corporate-owned businesses that have hired physicians like the managed care organizations did. It's almost a parallel model of what we saw in managed care."
Is clinical research a good career opportunity for psychiatrists?
Yes, said Getz. "My view is that it's particularly good as a way to supplement income, because it can be very exciting from a science perspective and it makes a physician's experience a much more diverse one."
But for those who opt to conduct trials as a business enterprise, many nonscientific skills are needed, he added. "To conduct this as more than just a scientific endeavor, you have to have a full business infrastructure to support the science," he said. "That's basically a new concept for most physicians. But some really love getting into the marketing and business challenges."
Not everyone is keen on the idea of entrepreneurial clinical research sites.
Samuel Guze, M.D., chair of the American Psychiatric Association's Council on Research, said he worries about for-profit companies conducting clinical trials.
"I just don't think it's wise," he said. "There's a big responsibility when you solicit volunteers for a drug treatment study, and the idea that somebody is doing this as a for-profit business and advertising for subjects creates so much uncertainty. If this is a lucrative business, then companies will be competing with each other and offering different inducements. I'm not saying that's happening, but it could."
But don't both universities and independent companies have economic motivation, and don't both advertise for subjects?
Yes, said Guze, but the university researcher doesn't benefit economically in quite the same way.
"Indirectly, he might benefit, but it's not as directly as the for-profit researcher. There's enough variation around the country that I can't be certain about how that operates, but I think that when you're advertising for subjects, you have a responsibility to be sure that the subject is fully informed and that you've fully considered ethical implications."
Wyeth-Ayerst spokesperson Doug Petkus, J.D., said independent firms provide an important service and called the choice between using an academic site or an independent company "subjective."
"These independent investigators offer the resources to perform all the intricate and painstaking steps required to satisfy FDA rules and regulations regarding clinical trials," he said, adding that selection of any site by pharmaceutical companies depends on a variety of criteria, including expertise in a certain therapeutic category, geographic desirability and a good track record in patient recruitment.