Getting Started: Clinical Research in Private Practice

Dermatologists tend to be curious people. As such, many become interested in research and with clinical trials. Because dermatology requires rigorous academic training, many dermatologists have exposure to both basic science and clinical research during residency and/or fellowships. 

If one pursues a career in academic medicine, research is an integral part of their job. In academic dermatology, one needs to affiliate with a laboratory or program that has funding and then establish an independent lab. Once that occurs, the race to get National Institutes of Health (NIH) funding begins. 

Unfortunately, this funding has been cut in recent years and the ability to do research in academia has become increasingly challenging. This has driven many doctors into the private practice arena and several continue to do research in that capacity.

Starting Out

However, starting to do research in private practice is a challenge. To put this in perspective, when my office started doing research more than a decade ago, I had some experience but my office was not setup for it and my staff had no experience with it. 

We began by attending several different research meetings and joining the Association of Clinical Research Professionals to gain exposure to this area. We also hired a consultant to help us. 

Over the years, we have expanded and learned a great deal about research. Some of what we have learned will be discussed at The Cosmetic Bootcamp Meeting in July. Much more will be discussed at The Clinical Trials Bootcamp next year. 

Pick the Right Coordinator

To begin doing clinical trials, one has to identify a staff member who is interested in doing them and invest the time and money training this person. 

One mistake that some people make is to assign a staff member to be the coordinator who does not have the skills or education to understand the requirements of patient safety, regulatory, informed consent and record keeping.

When starting out, either identify someone that is meticulous in your practice who wants to make a change or hire someone who has experience from outside your practice. 

Get Educated

Start by doing the NIH online courses about patient safety. These are requirements and are helpful in terms of beginning to understand the regulatory environment that governs research. 

Then attend some research meetings and take classes in informed consent, negotiating budgets, dealing with institutional review boards and similar topics. If after attending this meeting you and your staff are still interested, it is time for the next steps.

Determine Type of Trial

Typically, the next steps include identifying research areas that you would like to pursue. For dermatology, this area is broad: some wish to investigate acne or psoriasis while others are interested in fillers and toxins. Whichever topic is of interest, one can easily decide whether or not to do a trial that is sponsored by a company or to create one’s own research protocol. 

In the beginning, I would strongly urge you to participate in a company-sponsored trial because companies are really good at training physicians and their staff as well as providing oversight. Ask a lot of questions when you are starting. Another good way to begin is to partner with another practice in the community to do a trial that may be in dermatology but being conducted by a non-dermatologist. This occurs frequently.    

Allocate Space and Time

Once you have decided to pursue trials, it is helpful to block the time and space to do them. In the beginning, you do not need a separate building. 

However, you do need to have the time and space to manage the patients, the coordinators and the files so that when the sponsor or the FDA visit, there is clear evidence of your commitment to the research. Also, set aside space with the capacity to store paper files for several years.

Additional Considerations

If you choose to submit your ideas to companies for sponsorship of a potential trial, several additional factors are worth considering. The first is to determine if the trial makes sense and is timely. 

For instance, a trial of onabotulinum toxin for glabella does not make sense because it is already indicated for that area. However, a trial of this product for another area might be worthwhile. 

Many companies have templates that must be completed to be considered for a trial. Filling these out requires a fair amount of time and effort so before doing them, consider the investment required. Reading the literature and looking at clinicaltrials.gov is a excellent way to figure out what is and is not interesting for a potential trial.

One considerable caveat with any trial is that one must be incredibly meticulous and employ staff that is like-minded. Trials are a whole different level of record keeping and if you are not prepared to deal with that increased time and effort, trials are probably not going to be a good direction for you to take. 

On the other hand, if you are curious and like to pursue new ideas, trials can be a beneficial way to diversify your practice. They can lead to additional benefits, such as publications and train-ing opportunities. 

I have enjoyed each aspect of the research that we do, but I am fortunate to have coordinators that are meticulous in their clinical skills. 

Clinical trials can expand your professional repertoire. If you are considering moving in this direction, I would urge you to join one of the clinical research societies and attend a few meetings. 

Dr. Beer is in private practice in West Palm Beach, FL. He is also a volunteer clinical instructor in dermatology at the University of Miami, a consulting associate in the department of medicine at Duke University and shareholder and director of the Cosmetic Bootcamp meeting.

Disclosure: Dr. Beer is an owner of Theraplex LLC, and consults, speaks or performs clinical trials for Medicis, a division of Valeant, 3M, Sanofi Aventis, Bioform Medical, Allergan and Stiefel, a GSK company. He is also a shareholder and director of the Cosmetic Bootcamp meeting.

Dermatologists tend to be curious people. As such, many become interested in research and with clinical trials. Because dermatology requires rigorous academic training, many dermatologists have exposure to both basic science and clinical research during residency and/or fellowships. 

If one pursues a career in academic medicine, research is an integral part of their job. In academic dermatology, one needs to affiliate with a laboratory or program that has funding and then establish an independent lab. Once that occurs, the race to get National Institutes of Health (NIH) funding begins. 

Unfortunately, this funding has been cut in recent years and the ability to do research in academia has become increasingly challenging. This has driven many doctors into the private practice arena and several continue to do research in that capacity.

Starting Out

However, starting to do research in private practice is a challenge. To put this in perspective, when my office started doing research more than a decade ago, I had some experience but my office was not setup for it and my staff had no experience with it. 

We began by attending several different research meetings and joining the Association of Clinical Research Professionals to gain exposure to this area. We also hired a consultant to help us. 

Over the years, we have expanded and learned a great deal about research. Some of what we have learned will be discussed at The Cosmetic Bootcamp Meeting in July. Much more will be discussed at The Clinical Trials Bootcamp next year. 

Pick the Right Coordinator

To begin doing clinical trials, one has to identify a staff member who is interested in doing them and invest the time and money training this person. 

One mistake that some people make is to assign a staff member to be the coordinator who does not have the skills or education to understand the requirements of patient safety, regulatory, informed consent and record keeping.

When starting out, either identify someone that is meticulous in your practice who wants to make a change or hire someone who has experience from outside your practice. 

Get Educated

Start by doing the NIH online courses about patient safety. These are requirements and are helpful in terms of beginning to understand the regulatory environment that governs research. 

Then attend some research meetings and take classes in informed consent, negotiating budgets, dealing with institutional review boards and similar topics. If after attending this meeting you and your staff are still interested, it is time for the next steps.

Determine Type of Trial

Typically, the next steps include identifying research areas that you would like to pursue. For dermatology, this area is broad: some wish to investigate acne or psoriasis while others are interested in fillers and toxins. Whichever topic is of interest, one can easily decide whether or not to do a trial that is sponsored by a company or to create one’s own research protocol. 

In the beginning, I would strongly urge you to participate in a company-sponsored trial because companies are really good at training physicians and their staff as well as providing oversight. Ask a lot of questions when you are starting. Another good way to begin is to partner with another practice in the community to do a trial that may be in dermatology but being conducted by a non-dermatologist. This occurs frequently.    

Allocate Space and Time

Once you have decided to pursue trials, it is helpful to block the time and space to do them. In the beginning, you do not need a separate building. 

However, you do need to have the time and space to manage the patients, the coordinators and the files so that when the sponsor or the FDA visit, there is clear evidence of your commitment to the research. Also, set aside space with the capacity to store paper files for several years.

Additional Considerations

If you choose to submit your ideas to companies for sponsorship of a potential trial, several additional factors are worth considering. The first is to determine if the trial makes sense and is timely. 

For instance, a trial of onabotulinum toxin for glabella does not make sense because it is already indicated for that area. However, a trial of this product for another area might be worthwhile. 

Many companies have templates that must be completed to be considered for a trial. Filling these out requires a fair amount of time and effort so before doing them, consider the investment required. Reading the literature and looking at clinicaltrials.gov is a excellent way to figure out what is and is not interesting for a potential trial.

One considerable caveat with any trial is that one must be incredibly meticulous and employ staff that is like-minded. Trials are a whole different level of record keeping and if you are not prepared to deal with that increased time and effort, trials are probably not going to be a good direction for you to take. 

On the other hand, if you are curious and like to pursue new ideas, trials can be a beneficial way to diversify your practice. They can lead to additional benefits, such as publications and train-ing opportunities. 

I have enjoyed each aspect of the research that we do, but I am fortunate to have coordinators that are meticulous in their clinical skills. 

Clinical trials can expand your professional repertoire. If you are considering moving in this direction, I would urge you to join one of the clinical research societies and attend a few meetings. 

Dr. Beer is in private practice in West Palm Beach, FL. He is also a volunteer clinical instructor in dermatology at the University of Miami, a consulting associate in the department of medicine at Duke University and shareholder and director of the Cosmetic Bootcamp meeting.

Disclosure: Dr. Beer is an owner of Theraplex LLC, and consults, speaks or performs clinical trials for Medicis, a division of Valeant, 3M, Sanofi Aventis, Bioform Medical, Allergan and Stiefel, a GSK company. He is also a shareholder and director of the Cosmetic Bootcamp meeting.