When Steven Herzog, MD, completed his residency at the University of Texas Southwestern Medical Center in 1989, he joined what was then a small neurology practice. The lead partner, Gary Tunell, MD, was (and remained until 2009) also the chief of neurology at Baylor and a clinical professor of neurology at the University of Texas Southwestern Medical Center at Dallas.
Because of Dr. Tunell's prominence in academic medicine, the two-man practice had the opportunity to participate in a number of clinical trials. Fresh out of residency, Dr. Herzog immediately began work on the trial of a new Glaxo drug called sumatriptan, soon to be approved by the FDA for the treatment of migraines.
“Dr. Tunell was the principal investigator, and I was the research department,” said Dr. Herzog. “I did all the paperwork, contacted everyone, and met with all the patients. Even though it was a fairly simple study and we were recruiting only 20 patients, it took a lot of time. I devoted months and months to the original study.”
The project gave Dr. Herzog the chance to learn at the bench just how to do community-based neurologic research — something that many neurologists in private or group clinical practice may wonder about. “I learned how intensive it was, and how important a research team is,” he said. “We would not have been able to continue with the higher level studies without developing a research team as our practice grew.”
BUILDING THE TEAM
That's one thing that virtually all neurologists who do research as a part of their clinical practice agree on: you can't do this kind of work to any significant degree without some kind of support team. It might be a full-scale research department or just a well-trained nurse practitioner with an interest in clinical trials, but the doctor can't do it alone.
“When I joined my practice in 2001, there wasn't any research going on here at all,” said Michael Reynolds, MD, who practices with Guilford Neurologic Associates in Greensboro, NC. “One of my partners at the time got us into an industry-sponsored stroke study, and I remember it well — it was the two of us, our nurse practitioner at the hospital, and one nurse in our office, all trying to do this ridiculous amount of work for this very intense protocol of a neuroprotectant for stroke. We worked ourselves crazy, but we really enjoyed the experience.”
Shortly thereafter, Dr. Reynolds and his partners hired a stroke director who'd had some research experience, so they continued to do more stroke trials. “We decided it was too big a burden to take on ourselves, so we contracted with an independent research group in Winston-Salem who had a nurse to do the visits. We would supervise and sign everything, and they would help out with the paperwork. That allowed us to really understand what we were doing, and get experience with what doing research was all about.”
Several years ago, Dr. Reynolds and his partners brought their trials management back in-house, hiring research coordinators to staff both inpatient and outpatient trials. “Some were hired from within, and some from other groups in town that were involved in research,” he said. “Nurses at the hospital who were interested in research wanted to join our staff.”
Dr. Reynolds is currently the principal investigator for three of the practice's 10 to15 active trials: the NINDS' chronic migraine treatment trial, as well as two industry-sponsored multiple sclerosis (MS) trials. “Learning from what we'd done with the stroke studies, we started going in different directions, like MS trials and headache trials,” he said. “We talked with people we knew in industry and told them about the size of our practice and the variety of patients we have, and they would come and offer us trials. You do one and you do a good job, and they start thinking about you for the next one.”
When Brad Klein, MD, completed his neurology residency at Thomas Jefferson University, he knew that he wanted to be a community neurologist. “But I also loved advancing the science of what we do,” he said. So when he joined the eight-neurologist practice at Abington Neurological Associates in Abington, PA, charged with establishing a headache center, he planned from the start to make research an important component of the center. Another partner was already doing clinical trials in stroke treatment, so the road had already been paved.
Dr. Klein immediately began to work with the Clinical Research Collaboration (CRC) of the NINDS, which aims to increase community-based neurologists' participation in NINDS-funded clinical trials. He became a principal investigator for the NINDS CRC Chronic Migraine Treatment Trial (CMTT), a phase 3 trial comparing the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.
“I have one research coordinator who is so good she is her own department,” Dr. Klein declared. “I identify the patients, we screen them, she does the paperwork, and we do a little bit of marketing between her, myself, and some other people in the practice. But she had no experience in research until a year and a half ago. Conducting trials in a community practice doesn't require the support of someone with a master's degree — just someone with the interest and the work ethic to get the job done.”
Dr. Klein estimates that the research aspect of his practice takes up between 5-10 percent of his time, mostly involving patient screening, reviewing paperwork, following up on e-mails, and participating in Webcast or telecast meetings. “But to some extent, the amount of work depends on the trial,” he said. “In contrast to the migraine study, I'm also involved in a stroke trial [the Albumin in Acute Stroke trial, or ALIAS], and if you're on call when the person with an acute stroke comes in, once you get the ball game started, it's a four or five hour stint in the ER to get everything started. The ALIAS trial is intensive up front, then tapers and gets easier as time goes on. The CMTT trial is just a nice, smooth ongoing process.”
Dr. Reynolds estimates that he puts in an additional five to 10 hours per week on his research work —“usually closer to five,” he said. “We're fortunate in having been able to hire some very good people who can do a lot of the legwork for us in terms of scheduling the patients and doing the paperwork, to allow us to make our time with the research patients very efficient and do just what the physician needs to do.”
Dr. Klein said he has been surprised by how enthusiastic his patients are about participating in trials. “As long as they were amenable to the possibility of taking two drugs, the possibility of getting better and improving science at the same time was very appealing to them,” he said. “When patients fail on so many different treatments, to be able to provide them with access to options that might not be available to general neurologists is phenomenal.”
“When someone comes to this office and is a candidate for a trial of a new MS drug, I have something to offer him that I wouldn't be able to otherwise,” added Dr. Reynolds.
Indeed, neurologists involved in community-based research agree that it has helped them to grow their practices. “When new patients who've been referred by the study see how comprehensive our headache management center is, they often ask if they can come back after the study is completed,” said Dr. Herzog. “Even patients who are not in the study see that it is a dynamic, growing practice that is interested in new information. The more studies we've done, the more we've become recognized in the community. It's secured our foundation in the community as dealing with a complex patient population. It's a self-generating cycle: the more studies we do, the more referrals of complex patients we get, and the more of these patients we treat, the better we get at it — and the more studies we're able to accommodate.”
The clinicians interviewed for this story all agree that it's also made them better neurologists. “Participating in trials allows me to really stay on the cutting edge of what is going on in these particular conditions,” Dr. Reynolds said. “It gives me a chance to have some hands-on experience with things that otherwise I would just be reading about.”
More than 500 community-based neurologists have undergone training provided by the NINDS Clinical Research, which qualifies them to participate in any of the trials run by the CRC.
What if you want to be involved in one of them, or with an industry trial? What do you need to know? Christy Jackson, MD, a specialist in cerebrovascular disease who moved from academia to private practice after a 15-year career at the University of California-San Diego, which she left at the rank of full professor, has some advice.
“When you're choosing a trial, you need to ask yourself three questions: first, is the drug or device a good idea? Is it needed? Second, is the trial designed in a good way in order to answer the clinical question? Is the methodology adequate? And finally, is the budget adequate to what you're being asked to do to conduct the trial?”
Obviously, community-based neurologists who are new to research might not be able to answer all these questions themselves. “Ask your mentors,” advises Dr. Jackson. “All neurologists went through a residency program at an institution where trials were conducted. Review what you know about the trial and its protocols with a mentor or someone who has been in clinical trials for at least a few years.”
If the trial is industry-sponsored, Dr. Jackson also advises asking colleagues probing questions about the company involved. “There are some I'd work with hands down — they've always been reasonable and answer questions promptly,” she said. “There are others who aren't organized, and you can never get an answer back, and I won't do trials with them for that reason. It takes experience to know that. NIH trials are typically very well run. Although they don't pay well, their methodology is excellent and they ask important, needed questions.”
The NINDS is now looking for new ways in which the CRC can encourage community neurologists to participate in research. “Our experience has shown that not all practicing neurologists are interested in becoming trial investigators, because of the time constraints involved,” said Petra Kaufmann, MD, associate director for clinical research at the NINDS. “The CRC has focused so far on trials, but in the future perhaps comparative effectiveness trials or outcome of interventions trials can be promoted — something that neurologists can engage in more easily. The goal of engaging practicing neurologists remains very important to the NINDS.”
Dr. Reynolds urges neurologists who are interested in research to get involved with the CRC. (Learn more about the CRC at https://secure.emmes.com/crc/home.htm). “They will hook you up with good people, and the trials they are doing are trials that aren't going to be done in industry, and are really good at asking real-world questions that neurologists want the answers to.”
FINANCIAL CONSIDERATIONS FOR CLINICAL TRIALS
BY GINA SHAW
Community-based neurologists who do clinical research agree that if you're looking to get rich, conducting studies is not the way to do it. Industry-sponsored trials tend to pay more than NIH-sponsored studies, but neither is exactly a gold mine. “We usually generate a little bit of income — enough to put toward CME activities for physicians and pay bonuses for the research staff,” said Michael Reynolds, MD. “It's more about offering the patients the latest treatments and keeping our practice and knowledge base at the cutting edge as well.”
But if you're not selective in the studies you choose and careful in your budgeting, pursuing clinical research in the community setting might actually cost your practice money.
Before committing to a trial, Brad Klein, MD, and his partners try to break down costs of each aspect of taking on the study. “This includes looking at the costs for labs drawn, EKGs, lumbar punctures, and imaging studies, as well as the time involved for a physician or research coordinator to spend in clinical visits, phone calls, and administrative time,” he says. “We try to negotiate ahead the costs of some services we cannot offer within our practice, such as MRIs.”
Dr. Reynolds adds another key element for acute stroke studies: on-call time. Since someone has to take call for these studies, try to negotiate an on-call stipend as well.
“After looking over these issues, we feel we are in the best position to decide if we can at least break even or generate some income through the study,” Dr. Klein said. “Thankfully, the studies we have been fortunate enough to participate in, including NIH/government trials, have been overall helping us to bring in income.”
Dr. Klein's practice has plowed that income back into their research efforts, hiring another study coordinator and renting more office space.
Dr. Reynolds advises neurologists starting out with clinical trials to make sure their patient population fits well with the target population. “It's more profitable —and much less stressful — to enroll well in three studies than try to do ten and struggle,” he said. “We only do a study if we anticipate we will enroll highly. We also learned a few years ago that most budgets have some ‘wiggle room.’ If you enroll well and negotiate a good contract, you can generally make a little profit, at least with industry studies. We also look carefully at our mix of studies, and try to maintain a good balance of government and industry funding.”