Wanted: physicians interested in clinical research
From the April ACP-ASIM Observer, copyright © 2002 by the American College of Physicians-American Society of Internal Medicine.
By William Hoffman
If you've always wanted to incorporate clinical research into your practice, there is good news: The medical research community is looking for physicians.
While the United States spends almost $50 billion a year on clinical research, much of that money goes to nonphysicians like PhDs and technicians. Only 19% of principal investigators in NIH-sponsored trials, for example, are physicians.
Even industry-sponsored trials, which almost always use physician-investigators, will need more. By 2005, estimates say, industry-sponsored trials will require 56,000 clinician-investigators, up from 33,000 in 2000.
Talk to experienced physician researchers, and most will tell you about the benefits of research: It can be intellectually stimulating and a new source of revenue. They are also quick to add, however, that one of the toughest parts about getting started is the lack of formal standards or certification process for doing research in your practice.
Veteran physician-investigators say all too often, physicians plunge into clinical research without preparing themselves or their practices. As a result, most conduct only one clinical trial, then give up.
Here are some tips to help you avoid that fate.
Preparing your practice
Depending on the type of research you are considering, you may need to add storage capacity for records and equipment, or even dedicated office space for clinical trial work. One physician who spends 80% of his time doing research said he spends $500 a month to store the documentation accumulated during more than 300 clinical trials over the years.
Even more important than adding infrastructure, however, you'll need to fine-tune your practice's staff. You, your nurses and assistants will all need training in the procedures (completing paperwork, working with research sponsors) and regulatory requirements (FDA's "good clinical practice" rules) of clinical work.
The tried-and-true way to learn is to start with small, simple trials and gradually gain the experience that will allow your practice to conduct more complex—and more lucrative—research. If you want more than on-the-job training, however, your local research community may be willing to help.
Temple University School of Medicine, for example, offers a 14-week "introduction to clinical research operations" course, and other major medical schools are following suit. In addition, organizations like the Center for Clinical Research Practice and physician subspecialty associations are increasingly offering assistance to doctors interested in research opportunities.
But no matter how much training you and your staff get, you'll also need a good study coordinator. The person in this vital role fills out the forms required by the study sponsor and federal regulators such as NIH and FDA, reviews data for completeness and accuracy, and answers data queries from sponsors and study monitors.
A good study coordinator can also help train your nurses, physician assistants and office staff in the exacting record-keeping standards of clinical research. Trials often require physicians to store subjects' records separately from other patient records.
An experienced study coordinator is so important, in fact, that some trial sponsors say they often value the position more than the clinical expertise of the physician. Andrea Meyers, associate director of clinical affairs at Health Decisions Inc., a contract research organization based in Chapel Hill, N.C., said an experienced study coordinator can tip the scales for her. "If I had two sites to choose from, a doctor with 25 years in research and a study coordinator with six months or a doctor with two years in research and a study coordinator with 10 years," she said, "I'd take the latter every time."
Stephen M. Salerno, FACP, Chair of the College's Young Physicians Subcommittee, said that another key to success in research is not to go it alone. "It's important to have a mentor who shares a passion for investigating uncertainties," said Dr. Salerno, who integrates clinical research into his duties as assistant residency director at Tripler Army Medical Center in Honolulu. "A mentor, along with classes offered by a clinical investigation department at a nearby academic medical center, can be a real help in getting started."
Dr. Salerno also suggested that physicians interested in clinical research avoid focusing only on large clinical trials. Instead, he said, take advantage of opportunities that are right under your nose. Consider projects like retrospective chart reviews you conduct as part of a quality improvement project, data from patient and physician surveys, and medical education studies based on your experience teaching students and residents.
Even case reports—writing up an unusual patient with a novel presentation of disease—or review articles summarizing a body of existing research can serve as an entree into larger research projects. "The trick to succeeding is embracing uncertainty and identifying questions that genuinely interest you," Dr. Salerno said.
Study sponsors all want experience, which is why preparing your staff is so important. Experts say that experience alone, however, won't guarantee that you get research contracts.
Ms. Meyers said that drug makers typically like specialists and subspecialists because their patient panels suffer from the conditions drug companies are studying. Similarly, large hospitals and prominent medical institutions, or facilities with notable specialties, tend to get more research business.
What if your practice does not offer subspecialty expertise or a particularly interesting patient panel? Drug companies "go where they know the expertise is," Ms. Meyers said. If you don't think your practice has enough clout to get a trial on your own, consider aligning yourself with a practice, hospital or other institution that already does pharmaceutical trials.
If that approach doesn't work, contact a contract research organization or a site management organization. Both organizations act as middlemen between trial sponsors and researchers. Ms. Meyers said both types of organizations accept applications from physicians interested in being matched to research projects.
These organizations can also help point out your practice's strengths and weaknesses. Ms. Meyers said that Health Decisions, for example, conducts qualification visits at applicants' offices before assigning them trials.
Inspectors meet physicians, inspect their offices, examine their patient population, review the local competition, analyze geographical distribution of patient load and assess physicians' personal and professional attitudes, staff qualifications and seniority. These organizations will sometimes tell physicians how to prepare themselves and their practice for a qualifying inspection.
One note of caution: If a trial sponsor seems more interested in your patient population than your practice's qualifications or skills, proceed carefully. Stuart J. Simon, ACP-ASIM Member, medical director of Southeast Research Associates in Austell, Ga., said that drug makers frequently approach physicians who have a desirable patient demographic and offer a research project that seems too good to be true.
The downside? Ill-informed or unprepared doctors may be taking on more than they can handle and put themselves at legal risk if the research doesn't go smoothly.
A new mindset
While clinical research requires a fair amount of preparation, veteran clinician investigators say that if done right, it will more than pay for itself.
Ms. Meyers said that depending on the type and size of trial, physician-investigators can earn up to $20,000 per patient. That is a ballpark figure, however, and can vary greatly depending on factors like the type of research—government or private sector, for example—and the length of the trial.
Dennis Ruff, ACP-ASIM Member, an internist who spends most of his time working on clinical trials at Healthcare Discoveries PA in San Antonio, has developed an extensive staff for his research projects, but he still finds clinical trials more profitable than patient care.
Dr. Ruff employs four full-time clinical research nurses to assist him, three full-time data coordinators to communicate with clinical research associates from pharmaceutical sponsors and a full-time recruitment nurse.
"Patient for patient, even with the added infrastructure, your margin is probably higher in clinical trials if you manage well," Dr. Ruff said. He explained that research can be more lucrative than patient care because you don't have to deal with second-guessing from managed care and Medicare.
That success, however, often requires physicians to adjust to a completely different mindset. For one, you have to walk a fine line between relying on your staff and not delegating too much.
Research veterans warn that if you delegate too much authority, you could get into trouble. One of the most widely used guidelines for practice-based research is form 1572 from HHS. Physician-investigators must complete this legally binding document once a drug trial has been proposed, but before it has been filed with the trial's sponsor and forwarded to the FDA.
Besides asking for researchers' qualifications and outlining "good clinical practices," form 1572 also spells out physicians' commitments. Because it holds researchers to certain standards, it is known as "the hanging document." If you sign the document and relegate your research duties to your staff, you can be fined or jailed for shirking your responsibilities.
Dr. Ruff said there are other significant adjustments for novice physician-investigators. For example, you must become familiar with intricate, unfamiliar rules such as the FDA's "good clinical practice" standards and International Conference on Harmonization guidelines for research sponsored by multinational entities. And you must embrace documentation and administrative procedures even more exacting than those required by Medicare and Medicaid.
In some instances, patient care could conflict with the goals of a trial. Dr. Ruff said that you may be giving some subjects a potentially lifesaving new drug while giving others a worthless placebo.
Experts say that physicians getting involved in clinical research should expect to confront the ethical implications of that kind of dilemma. They also say that the opportunity to learn new skills and explore new challenges is what makes research so interesting.
"As anybody with experience in this industry can tell you, there are pitfalls everywhere," Dr. Simon explained. "There aren't many people who have done this for any length of time who haven't stubbed their toes occasionally."
William Hoffman is a freelance writer in Fairfax, Va.
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