How to Get Involved in Clinical Trials

Alexa Hetzel, PA-C, discusses practical steps for dermatologists, PAs, and NPs interested in clinical research, from finding trial opportunities and understanding regulatory requirements to building the right research team. Learn how to evaluate study feasibility, maintain ethical, patient-centered care, and successfully integrate clinical trials into everyday dermatology practice.

Transcript

Hello, my name is Alexa Hetzel. I'm a physician assistant at Schweiger Dermatology in East Windsor, New Jersey, and I am the director of clinical research at our site.

For dermatologists, PAs, and NPs who are interested in clinical research but have little or no prior experience, what are the most practical first steps for becoming involved in a clinical trial, and what should they look for when evaluating potential opportunities?

Dr Hetzel: What I would say is reach out to all of our industry friends and colleagues. Speak with our MSLs. They are kind of the gatekeepers in not only understanding what companies are coming next, but it also helps expand our horizons in terms of the amount of data and research that is there. Because if we're not familiar with the data and research that exists, we need to make sure we familiarize ourselves with it. What do endpoints look like? What are other companies doing? Make sure that we're understanding what's already out there before we're looking forward and progressing.

We also want to make sure that we're keeping up to date. We're reading journal articles. We're seeing what's moving in our fields, whether it's psoriasis or eczema or actinic keratosis. Where are we heading in terms of our treatment options? Learn the jargon. Learn how to speak clinical trials, which seems so silly, but ultimately it is kind of another language, which is why everybody doesn't do it.

Make sure we understand all of those touchpoints. And then lastly, connect with a colleague that's doing it as well. It might sound great on paper, but until you know what's really involved, you won't be able to experience that unless you're talking and engaging with someone that's already in the trenches with it currently.

What are some of the biggest operational, regulatory, or ethical challenges clinicians should anticipate when participating in clinical trials, and how can practices prepare for these responsibilities while continuing to provide high-quality patient care?

Dr Hetzel: I could never underestimate or undervalue my operations and regulatory teams because they really help keep things going. I am a busy provider. We are busy providers. We're still seeing patients throughout the day. So all the backend things of the operations: When are these patients being scheduled? Are they on regular schedules or a different schedule? When are they supposed to be seen? What about the questions and the evaluations and the PROs that they're coming in for, or the labs? My regulatory team is like another staff of medical assistants that is doing all of that, and you need that support.

Regulatory is huge. That's probably the most important position that we have within clinical research because they are the people that keep you from getting in trouble with the FDA. We don't want to mess with them. So we're making sure all of our trainings are taken care of, that we're okay and in line with the IRB.

If our application is expired, they're resubmitting. Our GCP and all of our trainings are up to date. That position is huge, and they also are tracking dollars and cents as well. So making sure our patients are being paid and that we're being paid properly and that they have all the contractual obligations as well. They are the keeper of the books, I will say.

And then when you're looking at the ethics of it, our job is to do no harm. We want to progress science. We want to make sure that we are treating these patients at the highest level. And there's an element of recruiting, and you don't want to feel salesy when you're talking about clinical research because is there a great FDA-approved option for these patients that they can get through their insurance, or do they want to go on an experimental product?

Ultimately, it's giving the patient the choice. We shouldn't just choose for them. We should give them the option. If we think this experimental trial is going to be a great opportunity for them, amazing. If somebody doesn't have access to these FDA-approved products, perfect, then we can give them another opportunity. But it's making sure we are not taking their voice away from that decision-making because they're the ones that need to go into this and want to participate. That's the biggest thing.

And then we can give them the highest quality of care from that perspective because they should know, "Hey, you may get placebo. There's a possibility for X amount of weeks that you get nothing. There's a possibility this doesn't work." There are a lot of things that we have to make sure that we incorporate and tell patients about when we're thinking about, "Okay, do we put somebody in a study?"

For clinicians considering integrating clinical research into their practice, what benefits can trial participation offer to the practice and its patients, and what factors should they consider when deciding whether research is a sustainable fit for their clinical setting?

Dr Hetzel: It's a loaded question, right? Ultimately, we are scientists. We want to progress the field of science. All of these treatment options that we have available for various dermatologic conditions didn't just come out of nowhere. We have to study them, and we do need patients for that. That's why it's important to remember the scientific part of it, and we don't always get it right.

The fact that some drugs get to phase 3 is honestly really uncommon. So just knowing that progression of clinical trials and understanding what it really takes to get through each phase is important. But it does offer your practice a little peek behind the curtain of, "Hey, what's next? Oh, this is exciting. This is going to be great. Oh my gosh, thank goodness."

And for our patients who maybe don't have access to other therapies or don't have insurance or are too young for some of the treatments that are out there and we need something else, it just gives us a little bit more opportunity to give those patients therapies that maybe we are already used to or maybe the next thing that's coming.

Ultimately, the biggest thing with research and figuring out if it's a fit for you is: Do you have the bandwidth and the capacity? I mentioned our research staff. I can't do this on my own without my research staff. So it's having those dedicated coordinators and regulatory that are only doing that job. Maybe you start off with one person, but you have to have somebody where that is their only job because otherwise it's not going to work.

The other thing is you don't just have to take on every study that exists. It's what you really think you're passionate about, what you think there's an unmet need for, and what you think you have the patient population to take over. If you don't have a lot of psoriasis patients, a psoriasis study is not going to suit you well at all because you're not going to be able to fill it.

But if you have a huge unmet need for lichen sclerosus, then perfect, take on that type of study. It's not just taking on studies because you want to get involved. It's making sure you're doing high-quality research and giving high-quality output because then that just makes you valuable to the sponsor who wants to work with you at the next step.

And you can continue to grow as you get more comfortable, but it's making sure that you're honest and open with yourself about what you can actually take on as a clinician without sacrificing patient care.