Financial pressure to bring new drugs and devices quickly to market has manufacturers striving to expedite clinical trials. The major holdup is finding qualified researchers and patients.
Now some physician practice management companies are stepping up to meet the challenge. They are creating or linking with site management organizations, or SMOs, which specialize in recruiting patients and moving them through clinical trials.
Because of their efficiency and size, SMOs are displacing independent physicians and academic medical centers (See chart). SMOs contract directly with manufacturers or with clinical research organizations, which are large companies that design and administer trials.
Site management is considered a natural outgrowth of what the best PPMs already do -- link large numbers of physicians with sophisticated information systems and standardize operational and clinical practices.
"Everybody understands there's a lot of inherent potential in that area" of clinical trials, says John Niles, vice president of marketing and corporate planning at Clinical Studies, an SMO that was purchased last fall by PhyMatrix, a West Palm Beach, Fla.-based physician manager.
Clinical Studies, based in Providence, R.I., runs 34 owned and affiliated clinical research facilities in 13 states. PhyMatrix intends to expand that business by funneling research to the more than 8,000 physicians in medical groups and independent practice associations that it manages.
Others PPMs are jumping in:
* Houston-based American Oncology Resources created its own SMO, now in its second year of operation, to coordinate research among its 300 physicians in 16 states. It completed trials on 200 oncology patients in 1997 and expects to move 1,800 more patients through trials this year.
* Birmingham, Ala.-based MedPartners acquired a CRO in its 1996 purchase of Caremark International. It is attempting to coordinate the research activities of its more than 13,000 physicians, roughly 10% of whom participate in clinical trials. The CRO is developing training programs for physicians and research coordinators, drafting standard contracts and spreading best research practices.
* San Diego-based FPA Medical Management signed an agreement with ClinTrials Research, a Nashville-based CRO, to establish a network of physicians to support clinical trials. ClinTrials expected to have 45 FPA doctors complete its training program by now, and it is marketing those physicians to drug companies. Ultimately, the company wants to have 500 to 600 FPA doctors on its roster.
Aside from efficiency and access to patients, PPMs say they can provide the Food and Drug Administration and product marketers with data relevant to mainstream medicine, rather than academic settings. For example, FPA and ClinTrials say their partnership will provide "much-needed access for research in the managed-care environment."
But academic medicine is not being left out of the picture. In November, PhyMatrix's Clinical Studies subsidiary agreed to partner with New York's Beth Israel Medical Center, which has a cadre of experienced researchers.
For practices that are new to research, clinical studies can be an operational challenge, says Randall Moore, M.D., senior vice president of integrated medical development at MedPartners. For example, research can disrupt patient flow.
"There are organizations that have to go through the learning curve," Moore says. "It's not just a slam-dunk; this is easy."
Also, the profit potential remains to be seen. Currently, some PPMs view research as a way to bring the latest science to their patients and their physicians, many of whom already are involved heavily in research, and to leverage their investments in technology.
"We would not go after clinical research if it did not have as a primary benefit enhancing patient care," Moore says.
Still, there's also hope of tapping big drug profits.
"PPMs derive their money either from the government or commercial managed care, both of which have been very tight with the purse strings. If you now go to pharmaceutical companies, you're looking at a whole different opportunity," says James Patricelli, a research analyst with Wessels, Arnold and Henderson, an investment banking firm in Minneapolis.
AOR, which is heavily involved in oncology research with a majority of its physicians participating, says it will be able to offer some prediction of future profitability in six months. Says finance Vice President L. Fred Pounds: "We don't have any internal proof of the impact at this point, but we're quite optimistic."