American College of Physicians: Internal Medicine — Doctors for Adults ®

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Getting the most out of community-based research

From the April ACP Observer, copyright © 2004 by the American College of Physicians.

By Tim Gray

Ira Klimberg, MD, was reluctant when a friend from medical school called, asking if he'd send a few clinical trials his way.

The Ocala, Fla., urologist had referred a few trials to the ob/gyn in the past, but his friend's performance had been mediocre. The problem? The physician seemed unwilling to devote the time and attention that Dr. Klimberg knew determined whether or not a community physician would succeed as a clinical researcher.

Dr. Klimberg, who has turned research into an important sideline for his practice, wasn't eager to squander his contacts or his professional reputation for someone else's half-hearted work. But when he tried to discourage his friend from taking on more clinical research, the physician said he was interested—and willing to invest the time and resources to do a good job.

"He said, 'My malpractice insurance is astronomical, and I'm getting killed with call,' " Dr. Klimberg recalled. "His plan was to make research a focus of his effort over two years. If he could generate enough income, he was going to give up ob and restrict himself to gyn. He said he was focused and committed and was willing to hire somebody full time" to coordinate his trials.

That was exactly what Dr. Klimberg wanted to hear. His friend's newfound passion and practicality were the key ingredients that would help him surmount the obstacles that are a routine part of doing clinical research in a community practice.

"Clinical research is real patients who have questions and problems, and they require time and close oversight," Dr. Klimberg explained. "It doesn't happen without a lot of physician involvement and work. Many physicians fail because they don't understand the depth of the commitment."

Setting expectations

To be sure, clinical research can provide a host of benefits for community physicians, including intellectual stimulation, early access to new drugs for patients and additional income. But both internists with experience in clinical research and drug industry executives warn novice researchers to be realistic about the time commitment, the hassles and the potential return.

"It's not a gold mine," said Jordan R. Asher, ACP Member, a Nashville, Tenn., internist and veteran researcher. "To augment your income, you're going to have to do it really well."

To do research in a community setting, you must first address a variety of ethical and legal issues (see "Legal and ethical considerations of clinical trials.")

Then there are practical concerns. Among the problems that come with clinical research are hiring the right staff, recruiting an adequate number of patients, and attending to a host of administrative details.

About 50,000 physicians a year participate in clinical trials, said Ken Getz, chief executive officer of CenterWatch, a Boston company that tracks clinical trials. Close to half of that group is doing the work part time, typically conducting only one trial a year. Many of these physicians try a study, become frustrated and drop out.

That leaves most of the work to be done by "the workhorses, dedicated research centers that derive 100% of their income from trials," Mr. Getz said. "Many of these are run by physicians who have stopped doing clinical practice."

Still, a few community physicians manage to thrive as part-time researchers, he noted. This small segment does four or five trials a year, Mr. Getz estimated, and generates about $300,000 a year in additional income. The average study grant for this group of physicians comes to about $60,000, or $5,500 per patient.

The role of research coordinators

Many physicians who successfully conduct clinical trials have one thing in common: They hire an experienced clinical research coordinator, typically a registered nurse who has worked in the pharmaceutical industry or on trials before. Veteran researchers say that a good study coordinator is a critical factor in whether or not you'll succeed with trials.

A coordinator's most important role is making sure a research site complies with the reams of federal, state and drug-company rules for conducting and documenting studies.

Bill Law Jr., MD, a Knoxville, Tenn., endocrinologist, is a partner in a six-physician practice that participates in six to 10 studies at a time. His practice employs two registered nurses who are also experienced study coordinators.

While nurses with the appropriate experience aren't cheap—Dr. Law pays them each about $45,000 a year plus benefits—he said they are essential to maintaining a top-notch research organization.

Piles of paperwork

Hiring a study coordinator can take wannabe researchers a long way to overcoming what may be the biggest hassle of doing research: paperwork.

"The amount of paperwork is incomprehensible," Dr. Law said. "You'd be stunned at the multiple three-ring notebooks. You can only believe it if you've done it."

Complicating matters, all that paperwork is closely regulated and scrutinized by the FDA. You can't mingle research files with other patient files, and you must store these files separately, either in their own cabinet or their own room, depending on volume.

You also need locked storage space for the drugs you use in clinical studies. And you need a place for drug company monitors to work when they conduct on-site reviews. (You can't just put a desk in a hallway.)

"You need dedicated space," said David L. Fried, ACP Member, a Rhode Island internist who's also medical director and princpal investigator for Omega Medical Research. "And it should be separate from your clinical space. It's easier to manage that way."

Dr. Fried has resolved the space problem by working with Omega, which is completely separate from his clinical practice. Because he's a subcontractor, he doesn't have to worry about any of the administrative burdens that come with clinical research. Staffers wrestle with it, letting him focus on working with the patient volunteers.

Recruiting problems

While paperwork is a major hurdle, an even bigger burden comes in the form of recruiting patients.

"You can never recruit too fast," said Dr. Klimberg, the Florida urologist. Even if a physician gets help recruiting patients from a contract research organization or a site management organization, the physician investigator and the coordinator have to qualify the candidates for a study individually. "It's a 100% local function," he said.

"Advertising agencies and recruitment firms will tell you that they can identify 1,000 potential patients for you," he added. "But of those, maybe only 10 or 20 will actually end up enrolled in your study."

In general, he estimated that the patient yield from advertising and recruiting firms is about 5%. With studies involving complex medical conditions, he added, the rate can sink even lower.

Some patients, for example, won't want to participate once they learn more about the trial's risks and expectations. Others won't meet the study's criteria because they have another medical condition that would confound the results, or they're taking another medication.

The low yield from recruiting tools like newspaper ads is why Neal L. Sklaver, FACP, a Dallas internist, uses his patients to recruit for research studies. He said he spends less time qualifying patients because he already knows the candidates and their medical conditions. Still, Dr. Sklaver said he occasionally finds it hard to recruit enough candidates.

"For one study, we were asked to find Hispanic patients with elevated lipid levels and other risk factors," he recalled. "I screened a large number of patients, but very few qualified. All the exclusions and inclusions in the study prevented me from enrolling an adequate number." Investigators aren't compensated for the time they spend screening candidates.

Dr. Sklaver warned that physicians who want to do research can't just chase studies, trying to participate in as many in possible. They have to choose carefully.

"You need to look at it realistically to see if you can provide the patients," he said. For instance, he was offered a study of a new test to screen for influenza in older patients. But because his practice does a good job of immunizing patients against the flu, he decided to not accept the study, knowing he would have few patients who would qualify.

Site management organizations

Because the logistics of clinical research can be so daunting, some question whether solo practitioners or small groups can effectively get involved.

One option is to work with a site-management organization (SMO). These groups allow doctors to band together to share the marketing and back-office costs of doing clinical research.

SMOs typically operate in one of two ways: They employ physicians as part-time researchers, or they work with a group of doctors who cooperate and share expenses.

AmericasDoctor in Gurnee, Ill., for instance, is an SMO organized to help doctors who already have some experience doing research. "We don't accept novice research sites," said Lee Jones, the company's chairman and chief executive officer. "We take only sites that have done three to five trials over the three to five years before they approach us."

While AmericasDoctor offers training for physicians, it doesn't hire research coordinators for them. That job—and expense—still falls to the doctors.

Despite the many headaches, community physicians who do clinical trials encourage interested colleagues to get involved—as long as they're pursuing research for the right reasons.

"Start small," suggested Nashville's Dr. Asher, "get used to how it works, keep your expectations realistic, and maybe partner first with a CRO or SMO."

Tim Gray is a freelance writer based in Philadelphia.

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Legal and ethical considerations of clinical trials

If you are considering getting involved with clinical trials, experts say you must spend time up-front putting adequate legal protections and procedures in place.

Even more importantly, physicians must consider critical ethical concerns before they agree to participate.

Physicians must assess the medical appropriateness of the proposed study, rather than simply taking the drug makers at their word, said William E. Golden, FACP, Chair of ACP's Ethics and Human Rights Committee and a professor of medicine and public health at the University of Arkansas. Studies can be marketing programs, he said, masquerading as science.

Physicians should also, Dr. Golden said, fully disclose to their patients the risks and benefits of participating, as well as the fact that the physician is being paid by a drug maker.

In an ethics case study in the March 2001 ACP-ASIM Observer on clinical research, members of the College's Ethics Committee highlighted other ethical concerns:

  • Physicians need to judge the validity and value of a study when deciding whether to participate. They should participate only in studies that have careful peer review.

    If they are unclear about a study's validity, physicians can contact medical schools to find a faculty reviewer.

  • Physicians should have all prospective study protocols reviewed by a hospital institutional review board (IRB). If their hospital doesn't have an IRB, physicians can contact the IRB of an academic health center that is willing to review protocols for a fee. (That fee can be billed to the company running the trial.)

  • Physicians must carefully consider the ethical implications of enrolling patients in placebo-controlled trials. Many ethics organizations now find that using placebo in trials is warranted only when doing so does not subject patients to any additional risk.

    As far as legal issues are concerned, David W. Hilgers, JD, a health care lawyer in Austin, Texas, suggested making sure that the drug company you're doing a trial for offers some sort of indemnity or that you have the appropriate insurance coverage.

    Physician investigators should also prepare some sort of written risk disclosure for patients who elect to participate in a study. Drug companies and contract research organizations often provide disclosure statements for physicians to use, Mr. Hilgers said, but they're not always clear enough.

    At the very least, he said, investigators should carefully evaluate such a disclosure statement before handing it out to patients. "There've been a number of cases where there were allegations that disclosures weren't adequate," he added.

    And like Dr. Golden, Mr. Hilgers stressed that physicians need to disclose any financial conflicts of interest, such as if they're being paid to conduct a study or if they're a stockholder in the company that created the drug.

    "The federal government is very interested in this issue," Mr. Hilgers pointed out. "If you're getting paid per patient [as opposed to a flat fee], the federal government says you have an incentive to bring in patients who aren't appropriate for a study. There are some egregious examples of physicians doing that."

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