By conducting clinical trials, you may become a recognized expert in your locale. Patients and colleagues can learn about studies in your practice, which may be a useful source of referrals. Speaking engagements at local, regional, and national meetings can be forums for heightening your practice’s visibility. This increased visibility can lead to a virtuous cycle of increased referrals for patient care as well as potential participations in current and future studies at your site. If you become a highly sought-after investigator, you may be offered co-authorship on key publications related to your research.

Clinical trials give you a break from the routine of patient care. Conducting research trials may make you a better clinician [7]. They allow you to approach medicine and a disease from a future-oriented, scientific perspective. They require you to review and understand pathophysiology, pharmacology, epidemiology, biostatistics, and study design. They require you to understand currently available alternatives to management of a particular disease. They expose you to the state-of-the art of a particular skin condition. Research trials often involve training which may augment or hone your clinical skills in diagnosing or evaluating a particular dermatologic disease. For many studies, you will be required to conduct complete physical examinations, review a variety of laboratory data—electrocardiograms, imaging studies—and review medical records including hospital records. This will keep your overall medical skills sharp and your awareness of a broader array of medical problems up to date. The extended contact involved with study participants with a particular disease may give you a better understanding of quality-of-life measures and other impacts of a disease on a subject and his/her contacts.

As you conduct studies, you will enhance your observation skills, and objectivity. You may take advantage of this by being a better diagnostician, or by beginning to develop and formulate hypotheses to conduct your own studies. In fact, many dermatologic therapies have resulted from such observation being put to use in clinical trials. Examples include observations of hair growth and lengthening associated with bimatoprost—originally used to treat open angle glaucoma—and minoxidil—a vasodilator developed for the treatment of hypertension; diminution of unwanted hair in subjects using eflornithine—originally developed for trypanosomiasis—and decreased flushing and telangiectasia in rosacea by brimonidine.

You will also be giving back. By offering novel therapies, and by providing care for those who can’t afford it, you will be an active participant in optimizing care for your community. You will also contribute to the advancement of medical and scientific knowledge.

Due to the short supply of physician scientists (currently less than 5 % of the physician workforce), the job market in this field is excellent. They are highly sought-after to become the future leaders of medicine and dentistry. Physician scientists hold leadership positions wherever they are: in academia, government, and private industry (including pharmaceutical, biotech, and venture capital companies). There are a number of industries interested in career investigative dermatologists. These include: pharmaceutical, biopharmaceutical, biologics, contract research organization, trial management organization, site management organization, medical research facility, university, consulting company, and device manufacturer. If you work for the government, you could work at the FDA, CDER, or CBHR. Specific jobs in industry include: clinical research physician, medical communications officer, manager clinical programs, director clinical trials office, regulatory affairs director, drug safety liaison, and epidemiologist. You could work as a principal investigator, a co-investigator, study manager, medical monitor, medical director, field physician, medical writer, chief medical officer, insurance company case reviewer, laboratory director, or product vigilance director. Depending upon your knowledge of statistics or information technology, you could be data coordinator, a biostatistician, a study designer, a clinical IT specialist, data analyst, data manager, or project manager. You could also be responsible for quality assurance as a QA/QC auditor, a technical writer, a regulatory specialist, or a QA/QC manager.

The challenges of clinical research operations are rising costs, the majority of which go to study personnel, with salaries consuming nearly 60 % of research grants. In addition to study staff, legal fees and compliance review costs continue to rise. Malpractice premiums, training costs, and overhead are increased as trials become more complex, and study requirements more onerous for study participants and study sites [8–11].

The costs of maintaining a medical practice are also growing, for many of the same reasons. These are rising overhead, declining reimbursement, and ever greater regulatory burdens.

If budgeted and run efficiently, clinical trials can generate modest income to offset losses or at least diversify practice income. Any additional income can be reinvested in the practice, or used as a cushion to sustain the practice during ebbs in revenue.

It’s harder for medical practices to recruit physicians, especially in rural areas. Pressures are discouraging doctors from continuing to practice. These include diminished income, autonomy, and increased overhead. Research can help offset some of these costs. But profit margins are suitable for most dermatology practices. Phase II trials are slightly better compensated than Phase I, III, or IV.

There are a variety of formal and informal ways of developing the skills necessary to become a competent investigator. One of the easiest is through networking. You can seek out dermatologists in your area who are conducting clinical trials. Offer to help by asking to be a subinvestigator. This will allow you to review the protocol, get appropriate protocol-specific training, see study subjects, and work closely with co-investigators, the PI, medical monitors, clinical research coordinators, and sponsors. If you have the opportunity to attend an investigator meeting, take it. Investigator meetings are good ways to meet new people and to network. They also provide detailed information on the study in detailed study packets combined with online training content. You will get presentations from noted experts including: scientific background on the investigational product or device by a bench research scientist, perhaps even the discoverer of the patent. The sponsor may go over the pharmacoeconomics of a particular agent. A medical monitor will review clinical data from earlier trials. You will see raw data from PK studies are reviewed. In-house MRAs or CRAs will cover topics related to the protocol such as inclusion and exclusion criteria, a study worksheet, case report forms, data collection, subject recruitment and retention, labs, investigational product dispensing and collecting, data entry, and adverse events. You will get presentations from laboratory personnel who discuss expected lab findings and anomalies. You will hear from regulatory personnel on dealings with regulatory agencies such as the FDA. You will also learn a lot from the discussions that ensue. For example, some attendees may question the study design, or details of the protocol. Obvious and subtle omissions or errors will be debated, sometime in great detail. You will come away from almost any investigator meeting with a deeper understanding of the clinical research process and a number of contacts to work with in the future.

There are standard web-based training courses. One of the best is the Collaborative Institutional Training Initiative (CITI) program. Recommended modules for investigators doing clinical trials include: good clinical practices for clinical trials involving drugs and devices; overview of new drug development; overview of international conference on harmonization; conducting investigator-initiated studies according to FDA regulations; investigator obligations in FDA-regulated clinical research; managing investigational agents according to good clinical practices; overview of FDA regulations for medical devices; informed consent; detecting and evaluating adverse events; reporting serious adverse events; audits and inspections of clinical trials; humanitarian use devices; and monitoring of clinical trials by industry sponsors. The National Cancer Institute (NCI) offers training on cancer clinical trials at www.​cancer.​gov/​clinicaltrials/​conducting/​clinicaltrialsco​urse

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