Check out industry's perspective on what is valuable in a physician regarding clinical studies. Learn more.
In last month’s column we explored the physician perspective for entrée into the sphere of clinical research. This month’s reveals the industry perspective on what is valuable in a physician regarding clinical studies, with three industry insiders providing a fair appraisal of the qualities and qualifications they seek in physicians partnering with industry in research.
These experts’ experience encompass a broad landscape of dermatology, from medical to aesthetic dermatology, medications to devices, and personal education from M.D. to Ph.D. and businessperson. Special thanks to Conor Gallagher, Ph.D. (Director of Medical Affairs, Allergan), Alessandra Nogueira, M.D. (Aesthetics & Corrective Medical Director, Galderma), and Marcel Besse (Executive Director, Lutronic & former President North America, BTL Industries) for their participation.
How and where to start
If you have a research concept, these experts agree that discussing it with an appropriate company medical science liaison (MSL) is the first appropriate step. According to Gallagher, “MSLs will be able to discuss research capabilities and experience and pass on the information to the appropriate group in the company Clinical Development or Medical Affairs departments.” Besse also suggests getting to know upper management involved in product development and medical affairs. Alternatively, he suggests that contacting a person you trust at the company “is always a good way to start the process.”
What type of study to start varies and there are multiple avenues to success. Novices in the field might benefit from conducting a small study that is observational or a review of the literature, according to Nogueira. Gallagher advises that “the best way to get involved in clinical research is [by] acting as a sub-investigator for an experienced investigator on a company sponsored clinical trial.” He asserts this is an excellent opportunity to build a skill set required for a successful physician clinician. Besse suggests that being a part of a multi-site study is another excellent opportunity, especially if a trial is straightforward and without requirements for pain management, histology or invasive procedures.
Industry heads won’t snap in the direction of flash-in-the-pan, quick-fix leads. Hard work, intellectual curiosity and dedication to science seem to be the recipe for success in clinical research. “Most companies like to work with well-established and well-respected luminaries as well as experienced young leaders,” states Besse. Past publications, a well-organized and trained research team, and proper educational training are key qualifications for selection as an investigator. Attending and presenting at scientific meetings such as the AAD and the SID impart credibility to your name, according to Nogueira. Gallagher highlights the importance of proper motivations for participating in research. It requires significant energy, passion, curiosity, and time. “Investigators should not expect to get involved in research for the money. While investigators are compensated for their efforts, it is really a labor of love,” adds Gallagher.
How to be successful over the long haul
Integrity, work ethic, and attention to detail are common themes among feedback from industry experts. Research is a laborious endeavor-proper staffing, facilities, and ethical behavior are required to be successful over a significant period of time. Another quality is worth noting: humility. “Receptiveness to feedback from company staff inspecting the site is important,” stresses Gallagher. The overall structure of your clinical practice may also dictate success over time. A diverse and large patient pool and having multiple, qualified investigators at one location are key determinants to inclusion in some studies. Consider how you lead your staff as well, as others are observing. According to Besse, “Physicians who command respect within their practices (which never comes without showing mutual respect to their staff) have clinical teams that are dedicated to their patients and their outcomes.”
“Formal research and regulatory compliance training today [are] essential,” stresses Nogueira, noting that, if pursuing a formal degree in the area of research is not feasible for a busy clinician, it is important for physicians to attend compliance and research courses at national meetings such as the AAD or through the FDA.
It is important to remain realistic and not be discouraged by setbacks. Gallagher notes that the environment of industry consolidation has led to a contraction in research opportunities. Even well-seasoned clinicians are not always selected for some studies for which they would be an ideal fit. Perseverance is definitely required, but within reason. Within the aesthetic sphere, Besse comments that financial rewards for the company and physician should not affect research outcomes. “Physicians should avoid pressures with conducting clinical studies with any bias toward the outcomes that all desire. We all must work together to insure that clinical studies best translate into quality outcomes and ultimately the true goal-happy patients.”
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