Marriage of town and gown brings clinical research to busy practices
By Phyllis Maguire
When she was in training, Diane M. London, ACP-ASIM Member, looked forward to a career as a clinician, teacher and researcher. Once she entered practice as a general internist and had her first child, however, that dream quickly faded.
Then in 1999, Partners HealthCare, the health system with which her practice is affiliated, began recruiting community physicians to work with its academic centers on clinical research. In the last year, Dr. London finished one trial on antidepressants and is now working on another trial on antihypertensives.
Dr. London said the arrangement gives her the best of both worlds. While she conducts clinical studies in her office at Charles River Medical Associates in Natick, Mass., she also gets to work with physicians from Partners' flagship teaching hospitals, Brigham and Women's and Massachusetts General.
"I wouldn't be comfortable if I wasn't doing the trials through my academic affiliation," she explained. "I don't feel confident that I can assess what study is a good one, and my hope is that the people at Brigham and Women's and Mass. General are better at that than I am."
Dr. London is part of a growing number of practicing physicians who are rekindling their love of research by enrolling themselves—and their patients—in clinical trials. While some community doctors have been working with private research organizations or drug companies for years, physicians like Dr. London are working with academic powerhouses to put research into their practices.
This marriage of town and gown offers advantages for both community physicians and academic centers. Practicing physicians can offer patients cutting-edge medications, while academic centers can recoup some of the research dollars they lost over the last decade.
Other academic centers and drug makers are watching these network pioneers closely to see if the model can fulfill its promise. The networks must first overcome some substantial hurdles-like the time crunch gripping most community-based physicians-to make their new partnerships succeed.
A new model
Academic and community physicians have long conducted research together, typically through informal collaborations. Within the last few years, however, a half dozen academic centers have created formal networks to enroll community physicians and their patients in clinical trials.
In part, academic centers want to capitalize on recent alliances with—or acquisitions of—community practices. They also want to reverse some bruising trends of the 1990s. Analysts estimate that in the last decade, academic centers lost $4 billion of drug company research to independent research organizations and community physicians.
According to the Boston-based CenterWatch, which tracks clinical research trends, academic centers in 1991 conducted almost 80% of all drug company trials. By 1999, that percentage had shrunk to 38% as research dollars shifted to for-profit research management companies.
"The idea was rather than fight them, let's join them," said Daniel P. Schuster, MD, associate dean of clinical research at Washington University School of Medicine in St. Louis and medical director of its clinical trial consortium.
There are variations among the networks. Some have community physicians doing both drug company and federally funded research, while others focus more exclusively on pharmaceutical trials. Some networks appoint faculty members as principal investigators, while others use community physicians to head their trials.
Yet most of the networks share key similarities. To pare down unwieldy bureaucracies, academic centers have created separate, centralized research grant offices. Those offices can offer sponsors multiple trial sites with a streamlined institutional review board process, and they offer a single process for budget, contract and legal review.
Most networks also employ and train research coordinators who travel among the community practices to collect trial data and manage paperwork, as well as quality assurance monitors who spot-check practices. And most networks use the Internet to keep community physicians connected to their academic counterparts.
Network physicians cite many reasons for getting involved with research. They can offer patients cutting-edge medications, enjoy a break from the treadmill of daily practice, and hone their clinical skills.
Yet they all say that a key reason they decided to join these new research networks was because an academic center was involved.
"It is a marriage made in heaven," said gastroenterologist Richard L. Curtis, MD, who is participating in polyp prevention trials with Partners. While he has worked on drug company trials with for-profit organizations in the past, he said that the Partners' trials have run more smoothly. He likes the fact that he doesn't have to incur a financial risk by hiring research staff, and he said that Partners' research coordinators keep better track of trial paperwork than he could on his own.
Network physicians also say that they are more confident of the scientific rigor and relevance of trials because an academic center is involved. Pittsburgh rheumatologist Terence W. Starz, MD, for instance, wanted to participate in phase two and phase three industry trials so he could offer his patients nonsteroidals and new fibromyalgia treatments. The university acted as a firewall to protect the studies' integrity, Dr. Starz said, something he wasn't sure a for-profit site management organization—which depends on drug company goodwill for all its business—could provide.
"The involvement of the academic center strikes a good balance," Dr. Starz explained. "It allows us to have an impact on the whole [drug development] process without becoming too incestuous."
Community physicians also appreciate a new revenue stream. W. David Watkins, MD, medical director for the University of Pittsburgh's clinical research network, claimed that community physicians who participate in two trials a year through an academic network can see $10,000 to $15,000 in new revenue. Because participating physicians work research into their clinical schedules, they aren't turning away patients—or clinical revenues—to do research.
Most primary care physicians in the networks say their research revenues are on par with clinical reimbursements. And though subspecialists may earn less on network research than they would on clinical consults, they cite other important advantages.
"It's not about the money," said Jay R. Seltzer, MD, a St. Louis-based nephrologist who is part of Washington University's research consortium. He explained that the real benefit of the study he participated in was it gave his patients with renal disease access to an expensive medication that is often not covered by insurance.
Hurdles for physicians…
Along with such positive reports, however, network physicians report some challenges. Because patients in suburban practices are less familiar with clinical research, for instance, physicians say they have to spend time explaining the potential benefits of a trial to get patients to enroll.
Screening patients can be another problem when you're working as both physician and investigator. In recruiting patients, physicians need to carefully consider the fact that some patients may get placebos during the trial.
"You have to enroll patients who may benefit from the medicine if they get the study drug, but wouldn't be harmed if they don't," said cardiologist Jonathan R. Ellis, MD, of Compass Medical in southeast Massachusetts, who has done several cardiology trials with Partners. (While enrollment can be a challenge, physicians say they like to enroll their own patients in trials because they can keep on top of adverse events that may arise during the study.)
Practice logistics can present another problem. Dr. London from Charles River Medical, for instance, discovered that her practice's scheduling system generates billing slips for any scheduled appointment. Insurers were being billed for research visits, while her subjects' lab results were filed in patient charts instead of study folders. Dr. London corrected these errors by training staff and providing oversight.
Perhaps most importantly, conducting trials takes time. Physicians may need to spend an hour with subjects during each follow-up visit, a burden when physician time is already parceled out in 15-minute blocks.
"We've had a number of physicians who wanted to dip their toes in the pond but found that the water was too cold," said Cynthia McGuire Dunn, MD, director of the University of Rochester's clinical research network. "It was a lot of extra work, and seeing a patient in a research context was not necessarily consistent with the flow of their office."
After four years and an investment of more than $1 million, the University of Rochester is considering cutting back its community network. "It's very hard for doctors to dabble in this or make it a hobby," Dr. Dunn said.
…and academic centers
Even those academic centers that remain enthusiastic about their networks' prospects admit to some growing pains. For one, it's expensive to build and maintain network infrastructures. Columbia-Presbyterian has spent $3 million on its network over the last two years on administrative and research staff and community physician training. Other networks report similar investments, and none have broken even.
Drug industry inertia presents another problem. While drug companies applaud the idea of working with multiple sites under one academic umbrella, network officials say that the drug industry has been slow to tailor its contracting procedures to the new multiple-site model.
Network directors also need some time to identify community physicians who are good researchers. "Three years from now, if someone from industry contacted me about a diabetes trial, I could provide the names of 12 excellent physicians," said cardiologist Marc A. Pfeffer, MD, medical director of the Partners HealthCare network, which was launched in 1999. "Right now, I'm trying to find those 12 doctors in each disease category."
Some networks have discovered that their affiliated systems haven't yet developed a common culture. Physicians who once competed for patients, for instance, are still slow to form new collaborations.
Most network directors point out that their new research networks are helping repair frayed relationships between academic and community physicians, cementing ties between academic centers—that are now the hub of far-flung health care systems—and their affiliated or employed physicians. It's one important reason why academic centers around the country are considering forming their own research networks.
Most academic centers, however, are stillseveral years away from developing their own version of these networks. Analysts say that before institutions can branch out into community networks, they have to streamline their review processes and centralize clinical trial management--a process that many academic centers around the country are scrambling to do.
Potential for growth
Most of the up-and-running networks remain very optimistic. For instance, Rowena J. Dolor, ACP-ASIM Member, director of Duke's Primary Care Research Consortium, said she expects the center's three-year-old community network to break even this year.
At least two other centers are expanding their research efforts. In Pittsburgh, the community network recently announced an exclusive partnership with the University of Pittsburgh Cancer Institute to conduct drug company trials. And in Massachusetts, the Harvard Clinical Research Institute plans to use Partners' network for many of its clinical studies.
So far, drug makers seem to like what they see. "We want to make sure that our drugs are studied not only in academic medical centers but also in physician practices," said Louis M. Sherwood, FACP, senior vice president of U.S. medical and scientific affairs for Merck & Co. "If academic medical centers can build these networks, it is easier to reach both."
Analysts point out that academic centers are already winning back some pharmaceutical research. According to CenterWatch, academic medical centers last year saw their share of drug company trials rise for the first time in 10 years, a comeback that should bode well for established networks.
Other forces may encourage community physicians to get involved in clinical research. Last summer, the Clinton administration announced that it would direct HCFA to begin reimbursing practicing physicians for clinical care expenses associated with research. In addition, some private insurers are beginning to reimburse physicians on a limited basis for patient care that is part of clinical research.
The down side is that clinical research regulations are getting tougher. Analysts predict that federal regulations for investigator education and certification will become stricter.
Network administrators, however, say that national requirements will only make their own community physician networks more attractive. "Fly-by-night research organizations will come up with meaningless programs to get past the regulations, " said Michael I. Leahey, MBA, director of clinical trials at Columbia-Presbyterian. "We will stand head-and-shoulders above them because we have academically developed, fully supported programs."
And while some community physicians look to research for intellectual stimulation and new revenues, others are finding new careers. Massachusetts cardiologist Brian M. Schwartz, MD, participated in several cardiovascular studies with Partners, thinking research would be an excellent part-time scientific endeavor. Instead, he found his true calling.
"When I got involved in these trials, I found them more interesting than my seeing patients day-to-day," he said. At the beginning of this year, Dr. Schwartz left private practice to become a regional medical research specialist for Pfizer Inc. He now organizes clinical trials for cardiovascular products—and sends business to the community physician network being run by Partners.
Columbia-Presbyterian Medical Center in New York.
Duke University School of Medicine in Durham, N.C.
Partners HealthCare in Boston.
The University of Pittsburgh Medical Center in Pittsburgh.
The University of Rochester School of Medicine in Rochester, N.Y.
Washington University School of Medicine in St. Louis
The Registry of Weight and Related Disorders (REWARD) Project is recruiting physicians to enroll patients. The project intends to periodically collect weight management, lifestyle and health data from those patients over three years.
Physicians who want to participate should call 877-71REWARD or send e-mail to firstname.lastname@example.org.
Boom times for clinical research - web only
According to the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group, drug makers spent $26.4 billion on clinical research in 2000, a 10% increase from the $24 billion they spent in 1999.
Percentage increases in federal spending are even more robust: According to the National Institutes of Health, the government funded $17.8 billion in clinical research in 2000, an increase of more than 14% from the $15.6 billion spent in 1999.
The number of individual investigations is also on the rise, as gauged by the number of Form 1572s, which investigators file with the FDA for each investigation at each site. According to the FDA, there were 41,600 individual Form 1572s filed in 1999, the last year for which it has complete data. That was a 33% increase over 1998.
Academic centers had a stellar year in 2000 for industry research. Reversing a decade-long trend, academic medical centers last year may have received a 40% share of industry research, according to CenterWatch, a Boston-based information company that tracks clinical trials.
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