Conducting clinical trials is one way for a practice to collaborate in the development of new drugs and devices, according to speaker Kenneth Beer, M.D., at last year's Cosmetic Bootcamp. He is a West Palm Beach, Fla.-based dermatologist in private practice and a cofounder of CBC, as well as associate clinical professor of dermatology, University of Miami Miller School of Medicine; consulting associate, Department of Medicine, Duke University; and clinical associate in dermatology, University of Pennsylvania Perelman School of Medicine.
Clinical trials also can provide a great opportunity for patients to get treatments before they are in the mainstream, he says. And if a practice provides satisfactory treatment for patients recruited for an acne or atopic dermatitis study, says Dr. Beer, these patients likely will choose to stay with the practice after the study concludes.
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The Clinical Trial Set-up
In setting up a clinical-trials program, says Dr. Beer, it helps to have an interest in and affinity for this type of work. In his case, "I love to publish, travel and work with drug companies on next-generation products."
Ideally, he says, a practice's clinical-study business should have a separate location, corporate structure and staff. Alternatively, "Once you have staff, you can hire other physician investigators to diversify" before embarking on a free-standing clinical-trials practice.
Whichever route a practice chooses, says Dr. Beer, "It's very important that you have one full-time study coordinator." Fortunately, he says, one of his nurses was able to become his study coordinator. "But I don't recommend that approach. It's really hard. Find somebody who's interested in clinical trials. They may not be highly experienced," but this person must be familiar with good clinical practice and open to learning the clinical-trial ropes. In these areas, he suggests using resources such as online tutorials available from the National Institutes of Health, as well as journals, organizations and meetings devoted to clinical trials.
What You Need to Know
Along with good clinical practice, Dr. Beer says that physicians and their staff also must be familiar with informed consent, recruitment, budgeting, negotiating and space and staff requirements.
Ultimately, "You'll need to know a lot more. And you'll need more than one clinical-trial coordinator. If you're doing 12 studies, you'll probably need three coordinators."
Furthermore, "Sponsors will look to see if you're really serious about it" and have a dedicated location with its own staff. Conversely, "If your front desk girl does your clinical coordinating while running charts around and answering the phone, it doesn't look good."
Additionally, Dr. Beer says it's important to show sponsors that your staff is being continuously educated. "But at least up front, the educational requirements are manageable."
Often, he says, drug companies will initiate trials by approaching experienced investigators. If this happens, "You can pick and choose which ones you'll participate in. The downside is, you must toe the line. You can't create anything new" within the study protocol.
Travel to investigator meetings also is required, he says, as is hosting monitoring visits from sponsors and/or the Food and Drug Administration (FDA). "Sometimes the sponsors want face time. And every time a monitor comes in, even if it's for five minutes, you have to meet with them" and answer any questions they may have. "They open up your books; they want to see what you're doing."
Ultimately, "You have to figure out if it's worth the time and money."
Investigator-initiated trials, on the other hand, require one to generate an idea, such as a new use for a neuromodulator, and propose it to a company or other potential sponsor, says Dr. Beer. This process is difficult, he said, "because you must come up with 10 ideas for everyone that will be accepted."
Getting Your Foot in the Door
Landing clinical trials of any type requires networking, he adds. To get started, "If you have a friend in another state who is looking for additional sites for a trial that sounds interesting, let that friend know you're interested." If one publishes in a particular area such as acne, lasers, neuromodulators or fillers, Dr. Beer suggests opening the dialogue with a potential sponsor by communicating your interest to the appropriate sales representative.
"It's a very long, arduous procedure. Nobody hands you anything. It's something you really must invest in. There's one company we have invited to our site three times a year — they've come probably once a year. I've still never done a study with them."
Tips for Trial Success
Of greater concern, he says, is that sloppiness and dishonesty in clinical trials can bring trouble from the FDA. In one such case, "A physician's assistant was doing trials and patient care at the same time and was found to be making up data. The FDA shut the site down."
Additionally, "Recruiting can be difficult." If your practice lacks a strong patient base and/or staff and fails to recruit the patients required for a study, says Dr. Beer, the sponsoring company will be disappointed because it will have spent money initiating your study site.
Above all, "Don't just do clinical trials for money. However, if you're interested in practice diversity, and it's the type of thing that intellectually fascinates you, it can be a good direction to take."
Disclosures:
Dr. Beer is the owner of ScientificRx Skincare. He has been a consultant and/or investigator for Allergan, Merz and Valeant, and virtually all makers of cosmeceuticals and in-office products. He also is a cofounder of The Cosmetic Bootcamp, which will begin offering a clinical trials boot camp for physicians of all specialties at a time and location to be determined in 2015.
