The Basics of Conducting Clinical Trials

From studying new topical creams that show promise in repigmenting vitiligo to biologic agents that revolutionize the way psoriasis and atopic dermatitis are treated, clinical trials explore the efficacy and safety of novel treatments for dermatologic diseases. Trials can even provide patients an option when it seems all other therapies have been exhausted. Dermatologists can reap some benefits by connecting patients with trials and even conducting them within their own clinics and practices.

“Participating in clinical trials helps the provider always know what is coming to market or what may be good alternative forms of treatment for patients who may not be getting better with what we currently have in our toolbox,” said Jorge Garcia-Zuazaga, MD, founder and president of APEX Dermatology, based in Mayfield Heights, OH. “It also adds a lot of value to the patient experience, because now you’re able to provide a patient with cutting edge therapies that they may not have had access to before. It helps separate your practice from any other group in dermatology.”

Making the Investment

“If you’re one of those people that like patient care but also like to learn new things and keep up with the most current literature, then clinical trials and clinical research may be a good next step for your career,” said Dr Garcia-Zuazaga. However, it is not a simple process, he explained. “This is not something that you do one hour a week to be successful. You have to make sure that you spend time and dedicate energy and resources to do it right.”

Dermatologists interested in adding clinical trials to their practice should know a few things about making the investment. “Before you can participate in any study, there’s a lot of training that you have to do. This is important training on how to conduct the clinical trials, what is the [institutional review board, and] what is ethics in research,” said Dr Garcia-Zuazaga. “Then, there is formal training that, I would say, most principal investigators have to take in order to show that you understand research, what it entails, and how to do it right and ethically. These are courses and training material that you have to complete before you are even considered to be a professional investigator on a study.”

Once a dermatologist has identified the desire and is ready to make the commitment, there are multiple financial and resource considerations to plan and fulfill.

“The other important thing is having the right infrastructure to be able to do clinical trials, because there is a lot of information gathering during these appointments. It’s not a 5-minute visit when you’re doing a clinical trial. All that takes training and all that takes time,” explained Dr Garcia-Zuazaga.

Practices that have a successful clinical trial component carve out the time to develop those aspects of the business. Previous articles published in The Dermatologist have touched on these aspects,^1,2 but a few of the resource considerations include:

• Hiring and/or training a research coordinator and research assistants
• Training current staff on protocols
• Financial support for conducting a trial
• Having physical space in the office for clinical trial work, such as a work station for the research coordinator, filing cabinets for long-term paper storage, or temperature-controlled storage for study drugs
• Patient recruitment and prescreening activities
• Long-term schedule commitments for investigator meetings or FDA audits

Dr Garcia-Zuazaga emphasized the importance of staff congruence on study protocols. “You have to have a solid clinical research coordinator in your team and maybe even some clinical research assistants to help you with the information gathering,” he said. “You need to make sure to develop the team so that when the patient comes in, every person that patient encounters knows the protocol. Additionally, everybody respects patient confidentiality and understands the ethics of clinical research, so that the project goes smoothly.”

Ethics and Patient Rights

While many of the previously discussed points highlight the upfront costs and ongoing factors in the business of a clinical trials practice, patients and their outcomes should still be the focus of care. Privacy and confidentiality are incredibly important to the patient, but also for FDA compliance as well.

“In any clinical research that I’ve dealt with, there’s always randomized, controlled trials where the patient information is completely deidentified. You’re given a site number, and the patient is given a number. None of their personal information is being shared with anybody,” Dr Garcia-Zuazaga said. “We also keep a separate clinical trial management system, which is almost like an [electronic medical record] but for clinical trials, that deidentifies all information associated with the patient while keeping it organized and monitored.”

Having a staff that understands these tools and requirements is imperative to protecting patient information. However, patients have some responsibilities in agreeing to participate in a clinical trial. To participate, patients need to provide informed consent, which requires the physician and the trial staff to explain in detail the goals of the research as well as the study drug. Patients should clearly understand that they have a role in the research as well, meaning that they need to adhere to the drug dosing schedule, but also that their disease may not improve as rapidly as they desire if they are randomized to a control group.

“It’s cool to be able to offer cutting-edge technology or treatments to patients that you see, because patients appreciate that. Many of them like to be part of something, especially if they’re getting better. You can say it’s a win-win for everybody,” added Dr Garcia-Zuazaga.

Planning for Future Trials

There are a growing number of opportunities to advance the science of dermatologic treatment. Dr Garcia-Zuazaga pointed to the rapid advancements in many diseases, including psoriasis, atopic dermatitis, and acne, as evidence that dermatology is a hot field with new research.

“I think that the more knowledge we gain through advance of science, and that is where clinical trials play big part. Then you can have these therapies available to everybody, and then at the end, that advances our medicine,” he said. “As you know, some of these skin diseases go a lot more than skin deep, so when we are able to treat the whole person and get them into the right state of mind by clearing their skin, it is just powerful. Clinical trials can deliver that extra boost for patients, because we have optimism for many new therapies.”

References
1. Conducting a clinical trial. The Dermatologist. August 2010. https://www.hmpgloballearningnetwork.com/site/thederm/site/cathlab/event/conducting-clinical-trial

2. Beer K. Getting started: clinical research in private practice. The Dermatologist. April 2015. https://www.hmpgloballearningnetwork.com/site/thederm/site/cathlab/event/getting-started-clinical-research-private-practice