Home Q&A Breaking down barriers to clinical research

Breaking down barriers to clinical research

November 2006

Published in the November 2006 issue of Today’s Hospitalisit

When it comes to quality improvement research, hospitalists nationwide are taking the lead in measuring the effect of key interventions on bed days and quality of care.

But when it comes to clinical drug trials, particularly in community hospitals, hospitalists have a much lower profile. Crowded wards and long shifts leave most hospitalists little time to devote to pharmaceutical research. And physicians who want to initiate trials often face a maze of logistical and administrative barriers, as well as skepticism from other physicians that research has any place in a community hospital.

Hospitalist James Welker, DO, has cleared all those hurdles. Two years ago, he launched the Franklin Square Clinical Research Center at Franklin Square Hospital in Baltimore, a now-thriving research enterprise where he conducts drug company trials on conditions ranging from deep-vein thrombosis to soft-tissue infections.

Acting as principal investigator and center director, Dr. Welker has found big payoffs in his own job satisfaction, as well as in rising patient satisfaction scores as measured in community surveys. At the same time, he enjoys enthusiastic support from hospital administrators and his colleagues, who are skeptics no more.

Dr. Welker recently spoke with Today’s Hospitalist about his experience conducting clinical research as a hospitalist.

How many trials have you completed?

More than a dozen, studying drugs before they’re approved and doing phase 4 research on new indications for already-approved medications. The research has gotten the entire hospitalist group up to speed on new drugs and new uses for old drugs before the rest of the community.

How unusual is it for hospitalists to initiate drug trials?

In the last few years, universities have started to recognize the value of hospitalist educators and now encourage or even require educator-initiated projects. But hospitalists at those institutions are often more interested in their own research and in publication than in drug trials.

A big problem for hospital-based physicians, particularly at community hospitals, is that trials require outpatient follow-up. Drug companies have tapped office-based physicians for research, but they are only now starting to see the value of sponsoring trials at community hospitals.

How do you handle follow-up?

Follow-up has to be done by an investigator, so if you are part of a group with an outpatient component, you could have an outpatient physician as one of your investigators.

We’re employed by the hospital, so we first took over part of the office we use for the hospitalist service for follow-up services. But as we started to demonstrate volume and revenue potential, the hospital supported us by setting up an office for follow-up and hiring four research coordinators. Within a year, we were breaking even.

Now that we have that space, we can take on longer trials. We’ll still identify patients for the trial in the hospital, but we may follow them for as long as two years as outpatients.

What other challenges have you run into?

There are major logistical issues for pharmacy, labs and radiology. Trials bring a lot of these services to the hospital; in one trial, we did between 40 and 50 ultrasounds over the course of six months. That makes hospital administrators very happy, but you have to spend a lot of time getting these groups to work with you.

Technicians may have to perform procedures in slightly different ways than they’re used to, while the pharmacy has to randomize medications. That takes work and may require an increase in their staffing. Those types of problems take a good year to smooth out.

Billing is another problem: You have to make sure billing is set up to separate out services for trials from patients’ clinical bills.

But the biggest obstacle is the prevailing culture, particularly when it comes to other physicians. While everyone agrees that research is important, we ran into a significant number of physicians who didn’t think we should be trying to enroll their patients.

Why would physicians be opposed to doing research in the hospital?

Community physicians pay their own liability insurance, and they’re afraid that having patients in trials will increase their liability. I don’t believe it does, but that’s a real cultural and trust barrier you have to clear.

How did you get around that?

Since we began the program, local patient surveys have found that patients’ perception of our hospital as a place where they can get the latest treatment and advances in health care has increased rather dramatically.

That’s mostly due to the fact that the hospital has invested in a lot of new technology, but I think the research is also a factor. Physicians whose patients have been involved in trials see that they’re happy and clinically doing well, and that’s made the doctors more comfortable.

We’re also now getting a lot of interest from specialists who want to do research but don’t want the hassle of setting up the infrastructure.

You mentioned liability concerns. Who is liable for trials?

The sponsor, which is typically the pharmaceutical company, has a tremendous liability. At the site level, the sponsor offers an indemnification clause releasing the site from liability “as long as the site investigator appropriately performs his job. As long as the trial is conducted appropriately, the site, along with other providers and investigators, should be protected.

Do you approach the drug companies, or do they find you?

A little of both. Even though we’re a community hospital, we’re part of a bigger health care system [Medstar Health Inc., a nonprofit network of seven hospitals], so other people in the system who are doing trials gave me some connections. I also talked to drug reps to get the names of their scientific directors. Once you perform a few trials well, your name gets circulated and the trials started coming in.

You can also tap into research networks like the Academy of Pharmaceutical Physicians and Investigators and the Association of Clinical Research Professionals. The latter has a certification process and can be a big help for young people.

How much time do you devote to research?

I spend at least eight to 10 hours a week doing research, though that can be 20 hours in busy weeks. Technically, this is on top of my hospitalist hours, but those are only 40 hours a week. We also get blocks of days off because we work so many weekend days, so there are some weeks when I don’t have a lot of clinical days and I can do more research. Other weeks, I tack on a couple of hours on the days I’m working clinically.

How are you reimbursed?

If there’s extra revenue in the year, I can allocate some of that to my salary. The hospital has quickly signed off on any payment I give myself.

How do you find patients to enroll?

That’s one of the keys to success. If you wait until a physician comes to you, enrollment will never happen. Doctors are so busy that they don’t stop and think about what trials we have.

Our HIPAA policy has a clause that allows us to search databases, so our study coordinators use our information systems to identify prospective participants. We then approach the patient to ask if there’s any interest. If there is, we’ll check the chart and speak with the physician.

How do you address ethical concerns about clinical research in the community?

Your obligation as an investigator is to first make sure that patients are appropriate for a trial and that they’re receiving the best available treatment. Most of our trials compare the best available treatment against the treatment being tested.

Making sure patients are appropriate is a real challenge. It sounds simple, but even when patients meet the inclusion/ exclusion criteria, sometimes they’re just not quite the flavor that the trial is looking for. Too often, people want to find a patient that they can sneak in, but that’s not in the best interests of the patient or the trial.

Once you find patients who are appropriate, then you run up against the limits of our knowledge. You truthfully don’t know which treatment is better.

At that point, it’s up to the patient. After you make sure patients are educated, you remove yourself from the decision-making and let them decide. As long as patients are appropriate and informed, then I don’t think you’re violating any ethical principles.

Phyllis Maguire is the Executive Editor of Today’s Hospitalist.