Medesthetics

JUL-AUG 2019

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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GETTING STARTED IN RESEARCH © GETTY IMAGES Girish "Gilly" Munavalli, MD, medical director and founder of Dermatology, Laser, and Vein Specialists of the Carolinas in Charlotte, North Carolina, recommends hiring a clini- cal trial coordinator if you plan to conduct research out of your practice. "A full-time clinical trial coordinator can help you with paperwork, organization, scheduling and com- munication, and sponsoring companies will know you're serious about research," he explains. "Part-time experienced coordinators are still a great option when fi rst starting out, to minimize overhead." Dr. Kaufman-Janette also encourages anyone considering clinical research to take a course on the roles and responsibili- ties of a principal investigator. Online clinical research training on GCP and FDA regulations as well as principal investigator training courses are available through the National Institutes of Health Offi ce of Clinical Research (ocr.od.nih.gov) as well as through several commercial companies. "Participating in clinical trials in your scope of practice is extremely rewarding, but you are accountable for what occurs in the study, not only during the trial, but for years after the study fi nishes," says Dr. Kaufman-Janette. "At our center, we have a full staff solely dedicated to overseeing the safety of all the trials and ethical treatment of the subjects. For smaller trials, you may be able to use your current clinical staff to help, provided they are trained on how to conduct clinical trials and on the responsi- bilities of doing so." SECURING THE FUNDING There are three main ways to fund clinical research: self- funding, industry funding and non-industry funding, which may include patient advocacy organizations, professional as- sociations or government grants. "You can obtain research funding from many organizations, such as the National Institutes of Health, the American Academy of Dermatol- ogy, the American Society for Dermatologic Surgery and the American Society for Lasers in Surgery and Medicine, as well as seek sponsorship from industry or other organiza- tions," says Dr. Ibrahimi. Industry funding, while the most common, may come with strings attached. For instance, the sponsoring company may want to determine the protocol used for the study— or, if they don't like your fi ndings, they may not want you to publish the results, says Dr. Gutowski. "There are inherent confl icts of interest, whether per- ceived or real, when industry is funding the study," adds Dr. Munavalli. "These funding sources may also have contractual control over the study results with regards to presentation and publication." However, he adds: "The pros of working with industry are the ability to fund the trial to completion and experience the gratifi cation of designing and running a successful trial." Karol A. Gutowski, MD, is a board-certifi ed plastic surgeon in private practice in the Chicago area. He has published more than 100 research articles and book chapters and is an international lecturer at scientifi c conferences. Omar A. Ibrahimi, MD, PhD, is the founder of the Connecticut Skin Institute. He is a regular speaker at national dermatology conferences and has published extensively on Mohs surgery, laser medicine and cosmetic procedures. Joely Kaufman-Janette, MD, is the medical director of Skin Associates of South Florida and the Skin Research Institute. She has been involved in numerous research studies and lectures internationally at scientifi c conferences. Girish "Gilly" Munavalli, MD, is the founder of Dermatology, Laser, and Vein Specialists of the Carolinas in Charlotte, North Carolina, assistant professor at the Wake Forest University School of Medicine Department of Dermatology and cosmetic dermatologic surgery fellowship director for the American Soci- ety for Dermatologic Surgery. 36 JULY/AUGUST 2019 | MedEsthetics

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