Clinical Trials Can Boost Your Bottom Line -- Are They Worth It?
Leslie Kane Jun 02, 2010
Introduction
As revenue continues its sink-hole slide, more and more office-based doctors are considering doing clinical trials within their practices.
While the income potential could reach into the hundreds of thousands (or more), there are enough obstacles to turn off many doctors. But given the possible patient benefits and the income benefits, a number of physicians are taking another look.
"From a remuneration perspective, conducting clinical trials is very positive relative to what we get from insurers; it's a positive amount for the time spent," says Jeffrey Danzig, MD, internist and gastroenterologist in solo practice in Ridgewood, New Jersey. "It's money you don't have to haggle over with insurance companies or go through numerous claim resubmissions; you know you're going to get paid."
A single study can pay $70,000; doing 3 or more at once -- which is typical -- can bring in significant income.
Besides the financial benefits, conducting clinical trials can bring other rewards.
"It allows you to nurture your academic side and to stay involved in the academic side of medicine," says Danzig, who has done about 20 clinical trials. "It also keeps you updated on the condition you're studying." Some of the trials Danzig has done involved looking at how a proton-pump inhibitor affects reflux and esophageal healing; another involved comparing a new inflammatory bowel disease drug to current drugs.
Additionally, patients may benefit from new or experimental treatments.
Administration Is a Big Factor
Still, clinical trials require a ton of paperwork, careful adherence to compliance and protocol requirements, and stiff reporting requirements. Many doctors conduct one clinical study and vow to never to do another.
"There is some tedium in getting a study going and getting all the logistical factors in line," says Danzig. "You have to sign all the papers, review the protocol. There's not only a time investment, but there's the tediousness."
Doctors also need to be aware of how conducting in-office trials can affect their office workflow and general practice operations, potential ethical issues, and other factors.
What Are Your Opportunities?
It's not hard to find an intriguing clinical trial: Pharmaceutical and medical device companies spend an estimated $25 billion annually on clinical trials in the United States.
Currently, there are more than 88,327 trials in 172 countries listed on the US government registry
www.clinicaltrials.gov. A large percentage of the US trials are carried out by doctors in office-based practices.
While many clinical trials take place at dedicated clinical research centers, pharmaceutical and device companies want more office-based doctors to take part. In 2007, sponsors recruited an average of 11 investigators (medical professionals conducting trials) per active investigational new drug. Today, clinical trials seek more targeted, smaller patient subgroups because of the diseases being studied, newer study designs, and cost issues.
However, most doctors aren't racing to become clinical trial investigators. Only about 1 in 8 (13%) physicians currently conduct clinical trials. Half of all physicians have never done so.
Why not? Some reasons cited include: no opportunity, too much time required, not enough personnel support, not enough resources, and burdensome paperwork. Overcoming these issues requires careful planning and some training.
The Pros and Cons of Conducting Clinical Trials
It's wise to consider several areas of clinical trials to determine whether they are right for your practice.
Additional Revenue
Some doctors find clinical trials to be very profitable. In general, companies pay in the $70,000 to $80,000 range for each clinical study.
"A medical practice can conduct more than one study at a time," says Carmen Arismendy, MD, CCRC, president of Arysmed LLC, a company that prepares private practices, hospitals, and clinics for doing clinical research. "If your office performed three at once, that's significant revenue for the physician, even after costs.
"If you hired a clinical research coordinator -- whose salary is in the $50,000-$60,000 range -- to coordinate the studies, that would enable you to conduct multiple studies and you would still be bringing in significant profits."
According to Danzig, a study that does not involve performing procedures might pay $200-$350 for the initial patient encounter and $100-$150 for subsequent encounters.
"For most studies, the formula for payment is based on the projected number of data submissions that you'll need to do," says Danzig. "A short study could require us to see somebody 12 times in a year, or a longer study might require us to see someone 14 times over 5 years.
"The pay factor is not how long the study lasts, but how much interaction you need to have as an investigator," says Danzig. "For example, as a gastroenterologist, we had to do endoscopies, or have a procedural event. That reimbursement would be greater than if the patient just has to come in for a visit and you do data collection in the office."
Of course, the revenue is prior to subtracting for overhead expenses involved with running the trials. "You'll need some support staff; if you don't have the right person, you need to hire him or her," says Danzig.
"You may not have all the right equipment you'll need for a particular study. You might need, for example, a centrifuge to spin down the blood sample, or a certain temperature freezer dedicated to the study drug, or a locked cabinet that you have to rent or buy. The average office that doesn't do studies typically doesn't have that equipment," says Danzig.
Helping Patients and Advancing Medicine
Most physicians are delighted if they're able to sometimes give patients the latest or newest treatments for their condition.
Particularly in the case of life-threatening diseases, if a patient has exhausted all the available treatment regimens, a clinical trial with experimental drugs may be his only hope for a recovery. Participating in clinical trials can help get experimental treatment to at least some patients who may be helped or whose life may be prolonged thanks to that treatment.
"Office-based physicians also point to the benefit of being able to provide more comprehensive care solutions to their patients through offering access to clinical trials and the opportunity to spend more time with patients compared with the highly limited interactions common under a managed-care environment," says Kenneth A. Getz, MBA, a senior research fellow at the Tufts Center for the Study of Drug Development and founder of CenterWatch.com, a resource center focusing on clinical trials.
Some doctors also appreciate playing an important role in helping advance science by testing new drugs.
"Participation in clinical trials provides a number of benefits to office-based physicians," says Getz. "According to interviews with several hundred community-based doctors, the opportunity to focus some energy on the frontiers of medicine is exciting. Many physicians like the more collegial atmosphere of a clinical research team that includes other physicians involved with the project as principal investigators and the sponsor company's research team.
How Will Clinical Trials Affect Your Regular Practice?
Clinical trials take time and possibly some rejiggering of your office workflow. (In our next installment we'll talk about how to get your office ready to do clinical trials.)
Unlike your regular patients who come to you when they're ill, clinical trials patients may have to come in frequently just to get monitored. For them it's partly a burden, and clinical trial sites need to be as accommodating as possible. That may mean adding flexible hours so that patients can stop in before work or at the end of the day.
Because most clinical trial participants are voluntary, offices that conduct trials take extra pains -- beyond those for their regular patients -- to avoid having the clinical trial patients wait. Some dedicated clinical trial centers say that 10 minutes is the absolute maximum a clinical trial volunteer might be required to wait to be seen (not just to be moved into the exam room). If patients drop out of the trial because they are annoyed at a long wait, it will upset your trial protocol.
A multiphysician office may be able to strategically reallocate the physician and staff schedule to see patients, get data, and do the required reporting.
For a smaller practice and especially for a solo practice, says Danzig, your best bet is to hire a clinical trials coordinator or use a clinical trials consulting service that sets up your office and gets it ready for trials, hires and preps the coordinator, and helps you recruit the required number of appropriate patients.
"A lot of those logistical issues are manageable if you have a third party help you do it," says Danzig. "That's what allows me as a solo practitioner to do this; particularly since I have no one else here to cover me."
Admittedly, using a third party adds cost, but Danzig says it's worth it. "Obviously, I would rather not have any cost and would like to be able to absorb more profit. But I probably would not be able to do most of these studies without a third party, and I would be getting nothing rather than something. The something I now get minus the cost factor is still positive compared to what I get from the average insurer seeing patients for the same time."
What Doctors Dislike About Clinical Trials
Paperwork and Regulation
Clinical trials require a considerable amount of paperwork, protocol, regulations, and record-keeping and often some training (Table). Some doctors who have taken part in a clinical trial were exasperated by all the record-keeping, document storage, report filing, efforts to keep volunteers interested, and other aspects of the trials. They did one clinical trial and vowed to never do another.
Table. Pros and Cons of Conducting Clinical Trials
PROS CONS
Can bring significant revenue without insurance hassles Entails significant paperwork, record-keeping, and protocols
Appeals to your academic side because of interesting and diverse topics available for study May require marketing expenses to find new patient
Provides new or experimental treatments to patients Could require a dedicated trial coordinator
Patients often enjoy participating For small or solo practices, may require third party to prepare office and coordinate
Could lead to increase in malpractice premiums and liability exposure
Training is recommended
Could affect office workflow and scheduling
Recruiting Patients
It's tempting to think, "I've got plenty of patients in my practice who will be in this trial." But in most cases, you'll have to recruit additional patients. Studies usually have strict criteria for patients and conditions, and you may not have sufficient patients who suit the rules of the trial (such as age and overall health).
Even if you do, it's unethical to pressure patients to take part. So you may need to recruit trial patients.
Some doctors are reluctant to ask even their own patients to participate. "For some physicians, presenting the possibility of being in a study makes them uncomfortable. Some would rather post a sign in the office than broach the subject themselves," says Danzig.
"The key is being forthright and candid in trying to drum up business," says Danzig. "You can say, ‘we have a study going on; here are the pros and cons for you.' You present it in an even handed nonsales way to let the patient decide. Then you can be very comfortable doing it."
If you need to conduct marketing and recruiting, you can do it if you have existing personnel with the appropriate knowledge. Or, you could use a consultant or marketing company to do it for you.
Ethical Issues
Some physician balk at the prospect of giving a long-time patient a placebo rather than a treatment that works to some degree. According to Getz, a majority of clinical trials do not involve placebos; they typically involve testing one dosage or regimen against another.When you read about the trial protocol, pay attention to whether a placebo is involved -- if you are uncomfortable with it, that is probably not the right trial for you.
Involve Others in the Decision
To make your trials and your office run smoothly, it's wise to plan in advance for all you need to do. It's also optimal to take classes or get training to help prepare yourself and your office to make your clinical trials venture successful.
For many doctors, participating in clinical trials is rewarding and provides a welcome revenue stream. When deciding whether you'd like to become involved with clinical trials, speak with other doctors who are doing them.
In part II of this article, which will be available next week, we'll talk about how to get your office ready to conduct clinical trials.
To find clinical trials to participate in, go to
www.centerwatch.com (click on Industry Provider Profiles) or
www.clinicaltrials.gov.
