Historically, professional researchers at academic institutions have conducted clinical trials. Today, thousands of physicians in private practice are conducting trials, and more join the field every day.
The rewards include earning additional revenue, staying abreast of cutting-edge therapies, networking with other physicians and offering patients more treatment options.
But there are drawbacks, including the need for additional trained staff, detailed record keeping, lab and other testing fees, intrusive oversight reviews, and a time commitment that takes physicians away from their other patients.
In other words, clinical trials can complement a practice and may add revenue, but they take a lot of effort.
"Clinical trials conducted in the practice is where everything is going in a groundswell," says John Brega, president of the clinical trial systems division of OrganicNet, an internet-based healthcare software company in San Francisco. "But if you're doing it only for profitability, you're likely to fail.
"To be a researcher, you have to be incredibly anal retentive about the details of treatment and the details of diagnosis. If you don't (deal with details) willingly, the pharmaceutical companies will quickly discover that and they won't come back to you to do more studies."
CenterWatch, a Web-based clinical trials listing service in Boston, estimates that 4,000 drugs were being investigated six years ago; today the figure is 7,000. Pharmaceutical companies are turning to individual physicians, rather than academic research centers, because the costs are lower and the study approval process is quicker.
Delays in getting a drug to market can cost pharmaceutical companies millions, says Kenneth Borow, M.D., president and chief medical officer of The Covalent Group, a full-service contract research organization in Wayne, Penn.
The opportunities appear to abound for physicians, yet Brega estimates that only 5% of physicians in the U.S. perform clinical trials.
Kathleen Drennan, executive vice president of strategic business development for Irvine, Calif.-based Clinmark, an online clinical research community, says around 240,000 investigators have filed documents with the Food and Drug Administration identifying the study they are conducting and what investigators are doing the research. But she says the number of active investigators is in the tens of thousands because most of these physicians conduct only one study and never try it again.
"They don't know how to do the studies, don't have the staff and aren't successful recruiting patients," she says.
Despite the challenges facing clinical investigators, the research field is growing, says Ken Getz, president and CEO of CenterWatch, due to mapping of the human genome, combinatorial chemistry and high-throughput screening, and drug companies quickly dropping drugs that don't look promising to try new ones.
He estimates that the average clinical grant is about $45,000, but per-patient rates vary widely based on the disease state and the difficulty of recruiting patients. (Cancer research pays better than dermatology, for example.)
Sometimes physicians are paid simply for referring patients to trials. The vast majority conduct trials in their own specialty. Drennan says the "hottest" areas are oncology, pediatrics, arthritis and women's health.
Trials can last from one to six years, and, like most things, start with paperwork. The sponsor (a drug company) or its delegate contract research organization approaches physicians to review the protocol, sign contracts, negotiate budgets, attend an investigators' meeting before the trial starts and go through a study site review, where the physician and study coordinator review information with the sponsor or delegate. Then physicians recruit patients, from their own practice or through advertising.
The study itself may involve collecting data, drawing blood, administering medications, ordering lab tests and completing reams of paperwork to document every step. Patients are seen as often as once a week, while others may be seen once a month. Physicians may get payments throughout the process, or, if the study is shorter than a year, receive upfront, middle and end payments.
Throughout the study, monitors from the FDA and the sponsor visit the study sites to ensure quality control; however, the FDA does not visit every site.
Getz says that "40% of all patients in clinical trials are stepping outside their primary care network, usually without their physician knowing it." But it's important that patients who are involved in trials do so with the knowledge of their current physician.
"The best way to recruit is from your practice because you know the patients, their history and health problems, and whether the trial would be good for them," says Drennan. Print and broadcast ads as well as direct mail are other recruitment techniques.
Some physicians have learned that although they can perform the medical requirements of the studies, they need assistance with the clerical and management aspects. "If a practice has less than five physicians, they're probably better off forming an association with several other organizations and managing their research through that association," advises David Gibson, chief operating officer of North Texas Clinical Research, a limited liability corporation formed by Urology Associates of North Texas in Arlington.
The group's 16 physicians are currently conducting five trials and negotiating for 14 more, with a goal of performing 30 to 50 per year. The group expects to double in size in two years.
"It's very difficult as a single physician to run clinical research studies because your staff has to double as your clinical research staff until you have a base of studies that's able to justify a single hire," Gibson says. "And in any given year, you may have a lot of studies or not many because there's a lot of fluctuation." Gibson's group is also forming relationships with physicians outside of their practice so they can help others conduct studies and earn fees for their assistance.
The 10 physicians at the Jacksonville (Fla.) Heart Center recently joined seven other cardiology groups to form the Cardiology Research Consortium. Jacksonville physicians began conducting trials five years ago to offer new therapies to patients who were not improving with available medications.
The failure of that group of patients to improve "really stimulated us to continue to do research," says Marc Litt, M.D., director of research.
"They were doing better, even if they were on a placebo, because they were coming in on a frequent basis, talking to someone, and not being admitted to the hospital as much."
But he cautions that the initial overhead was an investment. "You do not necessarily make money the first year, because you have to hire the right trained staff, have FDA rules to follow, and monitors come by to go over all your trials. We have a profit now, but we do trials because they provide us with another source of benefit for our patients."
Litt estimates that 10% of the group's profit comes from research, while 50% of their expenses are related to research needs.
Technology should advance the trials process. The Internet increasingly helps physicians and patients find both clinical trials and each other. And software currently used in only 5% of trials is expected to allow collecting and tracking of more data from remote locations.
"As clinicians are more able to capture the entire range of the clinical experience in electronic systems, they'll be able to broker that data to the pharmaceutical industry and other sponsors in a way that will revolutionize that business," says OrganicNet's Brega.
Data security and evidence of a "paper trail" showing clinical changes during the trial are key issues in software development, says Borow.
Presently, only a tiny fraction of those patients who are eligible for trials are participating in them. "If we're really going to get as many patients as possible, we're going to have to educate patients about what trials are and what the value of participating is," says William Terry, M.D., vice president of corporate sponsored research and licensing for Partners HealthCare System in Boston.
Whatever motivates physicians to conduct research, they need to keep patients' welfare in mind. "The whole healthcare industry has a foundation in patient trust," OrganicNet's Brega emphasizes.
"If you lose the trust of your patients, you might as well take down your shingle."
Robin F. DeMattia is a freelance editor and writer based in Fauquier County, Va.