Trialing it out

By Victoria Houghton, assistant managing editor, July 2, 2018

Dermatology World talks with Craig Leonardi, MD, from Central Dermatology in St. Louis, about how to make a research practice successful. 

Dermatology World: Tell me about the research arm of your practice?

Dr. Leonardi: Central Dermatology is a private practice that’s about 20 years old. We’ve been doing clinical research here since the first day we opened the doors. Clinical research has always been a big component of my private practice here at Central Dermatology, but I’ve been doing clinical research for more than 30 years. Before I was in private practice, I did research at St. Louis University in Missouri and before that the University of Miami in Florida.

Dermatology World: How many patients typically participate in your trials?

Dr. Leonardi: Usually we have 100 to 150 patients enrolled in a dozen active research trials. At any one time, we are actively enrolling three or four studies with these trials being the most intensive in terms of scheduling, procedures, and contact with the research staff. After this period, the number of visits decreases with time to a point where we might only see the subjects every three months.

Dermatology World: What conditions are you primarily focused on with these trials?

Dr. Leonardi: The research I like doing is related to psoriasis. Also, there are similar drug development efforts now in atopic dermatitis. We’re hoping that the atopic dermatitis story will mirror what’s happened in psoriasis because both groups of patients have unmet medical needs.

Dermatology World: Why did you decide to integrate clinical trials in your practice?

Dr. Leonardi: I created an integrated environment because it was a natural flow for many patients. For example, what happens at the end of the study? Do you dump these patients into the street and tell them you’ll call them later on? I’ve never felt comfortable with that model and try to find a soft landing for these patients. Remember, these are human beings and not lab rats on a wheel. You want to treat them with dignity and respect.

Dermatology World: What methods do you utilize to recruit patients for these trials?

Dr. Leonardi: We find a lot of our study subjects by word of mouth. In addition, my colleagues in St. Louis have really supported us well over the years by sending their patients. We will also advertise on the radio and cable TV.

Dermatology World: Your trials are sponsored by pharmaceutical companies. How do you go about finding and participating in these trials?

Dr. Leonardi: After all these years, the pharmaceutical companies know us well and decide that they want to include us. Apparently I have a reputation for performing high-quality clinical research. However, to get to that point, it took a lot of work. If you’re starting out, you need to contact the medical directors within the company and let them know that you’re interested in working with them and that you are committed to performing good-quality clinical research. The medical directors are usually receptive to that approach and you’re going to get put on a list. When they have a new project, they will work their way down that list. Eventually you’ll get the call.

Dermatology World: Before signing a contract with one of these companies, what do you typically do to make sure that the contract lines up with your priorities and objectives?

Dr. Leonardi: I have a small team that reviews the contract and the budget. My lawyer deals with the legal document with an eye to protecting my interests. A second person negotiates the budget and prepares the regulatory documents. While both of these tasks are time consuming, it is more efficient to outsource these activities.

When evaluating a budget, we refer to the schedule of activities provided by the pharmaceutical company. From that schedule, we generate a budget and compare it to the one offered by the sponsor. It’s important to look at that budget and make sure that the compensation makes sense for your cost structure.

Dermatology World: What are some red flags that the physician and/or their lawyer should look for in a contract?

Dr. Leonardi: On the legal side, the big issues involve intellectual property rights and reverse indemnification. In terms of intellectual property, sometimes the contract claims that the sponsor literally owns every thought in my head. Sorry but the reason I am usually included is because I am experienced in clinical research, trained as a dermatologist, and the sponsor wants to have my input on issues related to the study. You can’t own my thoughts.

In terms of reverse indemnification, we don’t accept any clauses which cause me to indemnify the sponsor. When you think about the relationship, it is very one sided. For example, the sponsor knows everything about the new drug. They choose to share some of that information with the investigators, who perform the work on a fee-for-service basis. If the project succeeds, the sponsor gets all of the reward and shares none. Under these circumstances, it really doesn’t make much sense for us to indemnify the sponsor for issues related to the drug.

Now we’re always willing to be responsible for issues that happen between us and the patient. Our malpractice insurance covers that possibility. However, that situation is very different from one where a patient is harmed by the sponsor’s drug.

As you can tell, some of this can be contentious. Occasionally a sponsor will refuse to remove indemnification clauses. We thank them for their time and walk away.

Dermatology World: On average, how much time are you spending on the clinical research side of things?

Dr. Leonardi: It varies depending on the number, type, and stage of the studies that are active. On average I spend somewhere between 30 and 50% of my time on research activities.

Dermatology World: What do these trials entail with regard to physician time, staff time, capital, and resources?

Dr. Leonardi: You have to be staffed up. I have a registered nurse who is in charge of the research unit. She is also the IV infusion nurse for studies requiring that mode of drug delivery. I also have two medical assistants who see study subjects throughout the day.

You also need enough space to do this work properly. I have 5,000 square feet with ample room for my research team. You must also accommodate a small army of monitors that visit the site periodically. Even simple things like storage of research charts (large binders) consume a lot of space. You need to have a -20-degree freezer and a refrigerator (and sometimes more than one refrigerator). Once we had a dozen EKG machines on site, each for a different study. We called that room the EKG farm! If there are photographs in the trial, we need a room suitable for taking photos with a large blue background. Because you don’t want to tie up an exam room with phlebotomies, we have a separate room just for that activity. In summary, we try to make efficient use of our space.

Dermatology World: What do you need to do to ensure that you are abiding by regulatory requirements for clinical trials?

Dr. Leonardi: You should have a set of Standard Operating Procedures and you should also be aware of Good Clinical Practice Guidelines for performing human research [https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm]. Also, whenever the sponsor sends out auditors to review the charts, you need to carefully pay attention to their findings.

Dermatology World: Is there anything you need to do with your malpractice insurance when adding a research arm to your practice?

Dr. Leonardi: In my case, the only thing my medical malpractice carrier was interested in was whether I was performing any cosmetic procedures in my practice. They did not seem to be fazed about my research activities. However, don’t stick your head in the sand. Call up your malpractice provider and tell them you’re doing clinical research. Let them know exactly what it is so they can adjust your underwriting if need be. It’s a simple phone call and you will sleep better for having made it.

Dermatology World: What are the benefits of adding a research component to your practice?

Dr. Leonardi: It’s a stimulating and educational environment. You are contributing to our specialty and to the patients, of course. You get a new understanding of pharmacology and the mechanism of disease. Additionally, some patients have unmet medical needs that are poorly served by the current treatment options. So an experimental approach might be good for them. There are also financial rewards. A well-run research site should be profitable.

Dermatology World: What are any disadvantages of adding a research component to your practice?

Dr. Leonardi: Over the years, I’ve performed more than 200 research programs under my supervision. Every now and then one slips through our legal and contracting process that is a poor fit. Unfortunately you are still obligated to perform the work. For example, in one study my patients received placebo for the entire study. It was a little frustrating for the subjects and for us.

Dermatology World: What advice would you offer a physician looking to add this model to their practice?

Dr. Leonardi: One of the best things to do is find someone who is performing clinical research in their practice. Give them a call and let them know that you’re thinking about adding a research unit to your practice. Dermatology is a friendly and helpful specialty. It should be possible to visit one of the large research centers for a day or two. Then you can make a decision about whether to invest more developing this capability.

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