The payoffs and pitfalls of participating in clinical trials.

MAUI, HAWAII -- Clinical trial participation can be a moneymaker for a practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Well.

"If you're looking to make a profit, you've got to get a profit," said Dr. Fleischmann.

"If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK." That extra in reimbursement provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, "You've got to figure out what your real charges are," and that includes allocating a reasonable portion of overhead to cover the share of phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

"You do have to think about your time," as well in determining the costs of doing a trial, Dr. Fleischmann added. "You have to go to the investigative meeting--it costs you a day. You have to do the site opening--that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in."

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can help protect against unforeseen expenses. "I can guess, in looking at the protocol, what's going to happen if it goes perfectly well," Dr. Fleischmann said. But things do not usually go perfectly well with resulting amendments to the protocol and deadline extensions.

The key is to have someone other than the physician negotiate the contract with the company running the research. Dr. Fleischmann, who is in a large group, has an accountant do this job. Find someone you trust "to have the wherewithal to say, 'This is what we really need." It has to be fair, Dr. Fleischmann added.

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate for him. "We play good cop, bad cop."

Dr. Wells and Dr. Fleischmann made their remarks at a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should select their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. And be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor (TNF) agents. Because only a few of his patients have not responded to TNF blockers, he has committed to providing "1 or 2 patients; we're not going to do 12 of them," Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against it. Work with patients from your own practice, he urged.

Don't count on outside sources, such as advertising, to bring patients on board. "Patient recruitment is a killer," he observed. "Nobody does it well."

If you don't have the patients in your practice willing to participate in a trial, he said, "you're not going to be able to do it."

Dr. Wells noted that convincing your patients to be in a trial can be tough. He reported find ing it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about use of COX-2 inhihitors with the possibility of increased risk for heart attacks and strokes has given his patients pause. Many times, the patient will decide to participate because of [their loyalty to] you, Dr. Wells noted.

Dr. Fleischmann urged the audience to "be your own center" when doing a study, or join with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations, he said.

Contracts should include clauses to provide for renegotiation if the company makes a change during the course of a trial. "Sometimes, companies will listen to it, and sometimes companies won't," he said. "But if you've got the study," he pointed out, and "you have patients in the study, you actually have a hook." For instance, your patients can be withdrawn from the study.

Dr. Wells observed that there are bound to be differences in perspective between physicians working in large group practices and those working in solo practices; between someone who has done "tons of clinical trials in a huge research group and somebody who is just essentially starting."

Noting that he might be in a somewhat different position from Dr. Fleischmann, who has done many trials, Dr. Wells said that he "might be willing to break even to get my foot in the door on a trial, or even make maybe just a little less of a profit." And, he said, "If you take the Celebrex trial as an example, you get to answer some interesting questions."

Dr. Fleischmann agreed sometimes there are reasons to do a trial other than for money. "There are trials where we don't make money," he said, "because there's an answer that we want to get."

There is no correct answer on how long to keep records after a trial. "A lot of companies will say 15 years. That's the usual," Dr. Fleischmann said. However, the Food and Drug Administration has the ability to go back and look at the data from a study at any point in time, he said.

"We keep them forever," he said, adding that he stores his records at Iron Mountain and the storage fee is part of the budget.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen, Centocor, Genentech, and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche. Dr. Wells is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, and TAP Pharmaceutical Products.

BY CAROLYN SACHS

Contributing Writer