Performing clinical research

Clinical research is a means of diversifying your practice, potentially attracting new patients, creating a separate revenue stream, and a way of becoming involved in cutting edge technological developments and therapies in dermatology. That being said, it can be a daunting task to start a research arm in a dermatology clinic. It can be even more perplexing to determine how to initiate a study.  Luckily, with the help of some seasoned veterans and a new up-and-comer, this month’s feature provides some insight for those interested in dermatologic research in the practice setting.

The path to building a practice that includes clinical research is unique to each physician. However, most funded studies, whether investigator-initiated or sponsored by industry, require you to be noticed by companies focused on dermatologic care. There are several ways to do this. 

One approach is to cast your net broadly and begin with a study that features a common dermatologic condition. Michael Gold, M.D., medical director of Gold Skin Care Center in Nashville, Tenn., has over 25 years of clinical research experience. He suggests an acne study for a first dip in to the research pond. 

“There are lots of patients and several large clinical trials that need new investigators all the time – something good for new investigators,” he said. However, he cautions, to start with a small study and perform well. “You need to show that you understand what goes into performing clinical research and understand the commitment that this takes.” 

Dr. Gold stresses that doing good work, following protocols, and making sure you have clean data for the sponsor are keys to earning consideration for future and/or larger studies.

Get recognized

Developing a presence that industry recognizes is important to building a lasting clinical research presence. Publishing articles, presenting at meetings, and becoming a thought leader are all avenues that increase your exposure to research opportunities.

Mitch Goldman, M.D., director of Cosmetic Laser Dermatology in La Jolla, CA , has over 30 years of clinical research experience, and he is a good example of this approach.

When asked how he first got started, Dr. Goldman reflects on multiple techniques for initiating research studies. These included being approached by industry, seeking them out, and even negotiating studies with the purchase of new devices and equipment. It requires hard work to get the proverbial research ball rolling, but Dr. Goldman adds “Keep trying,” for those truly interested in clinical studies.

Jennifer Peterson, M.D., an associate at Suzanne Bruce & Associates in Houston, TX, says clinical research is an expanding area of her day to day activities. 

“My interests in research developed organically during my years of training,” she said. Having completed both a research fellowship and subspecialty cosmetic surgery training, Dr. Peterson was exposed to both basic science research and clinical trials. Now at an established practice with a dedicated research team including a director, clinical research coordinators, and screeners, she can expand on her foundation of research exposure.

Regardless of how you start, it is important to build a knowledgeable and trustworthy research team. Staff may include

• research director,

• coordinators, nurses,

• and even research fellows. 

If you are new to research, these team members may provide invaluable experience in setting up a research arm to your practice.  Information on clinical research is also more readily available to the clinician.

According to Dr. Gold, “Most of what you need can be found online or by asking drug companies to provide you some of the information.” 

Dr. Peterson has found that mentors and like-minded colleagues were the most helpful resources in conducting successful research projects.

Categorizing studies

Clinical studies fall into two broad categories, company-sponsored and investigator-initiated trials (IITs). In company-sponsored studies, the protocol is pre-determined and investigators are selected by the sponsoring entity. If a physician performs well, this may lead to other future studies. However, difficulties in enrollment, data collection, or overall communication could lead to a poor reputation for the physician in the industry.

Investigator-initiated studies require much more effort on the part of the researcher. The protocol development, study initiation, and project completion are all overseen by the investigating physician. While this provides more autonomy and the opportunity to start out with a smaller more manageable study population, there are potential drawbacks. 

Dr. Gold says “Doing IITs are great but you take on all the risks associated with them.” He also cautions that you should verify with your malpractice carrier that you are covered for any inherent risks associated with such studies.

The physical space necessary to conduct clinical research is also a consideration for initiating studies in your practice. All three physicians report that they have dedicated research wings that include clinic rooms, staff offices, photography suites, and storage. 

So why take on clinical research you may ask? There are financial, academic, and altruistic benefits of participating in these activities.  For Dr. Goldman, he enjoys “providing the most advanced care, at the forefront of medicine, and treating nice patients that otherwise would be unable to afford it.”  For Dr. Peterson, “It is about enhancing our specialty, increasing patient access to care, and enjoying the process as I continue to learn.”  All of us agree that the hardwork and dedication in participating in clinical research are well worth the reward – advancement of the specialty.