Derm-it Trotter! Don't Swear About Skincare.
Feeling frustrated or overwhelmed with everything skin? Does the skinformation overload make you want to swear about skincare? Join Dr. Shannon C. Trotter, board certified dermatologist, as she talks with fellow dermatologists and colleagues in skincare to help separate fact from fiction and simplify the world of skin. After listening, you won’t swear about skincare anymore!
Derm-it Trotter! Don't Swear About Skincare.
Clinical Trials: How You Can Help Move Medicine Forward
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Wondering about the practicalities of joining a clinical trial? We’ve got you covered. Dr. Serrao, a leading dermatologist in clinical trials, and host Dr. Shannon C. Trotter discuss the importance of informed consent, safety measures used during trials, patient autonomy, and the supportive role of healthcare providers in decision-making. They offer tips on assessing trial risks and benefits and highlight helpful resources like trialstoday.org for anyone interested in exploring trial opportunities. From understanding placebos to navigating access to post-trial treatments, this episode is your go-to guide for becoming an informed participant in a clinical trial helping to advance skincare.
Understanding Clinical Trials in Dermatology
Speaker 1Welcome to Dermot Trotter Don't Swear About Skincare where host Dr Shannon C Trotter, a board-certified dermatologist, sits down with fellow dermatologists and skincare experts to separate fact from fiction and simplify skincare. Let's get started.
Speaker 2Well, welcome everyone again to the Dermot Trotter Don't Swear About Skincare podcast. We have a special topic we're going to talk about today clinical trials. Might make you think twice about wanting to continue to listen, but stay tuned, we're really going to show you why clinical trials are basically just research with new medications. Devices are so important, especially in the world of skin, and I've got a great guest on today, dr Rocco Serrero. He's a board certified dermatologist who does both general and medical dermatology, most of his time seeing patients and acting as a principal investigator of clinical trials. He's a head honcho in these studies, guys, so he's an expert. He really enjoys teaching medical students, residents and his fellow clinicians, and he spends his free time with his husband Mark, three-year-old daughter Madeline and their dog, sydney.
Speaker 3So I'd really like to welcome Dr Sorreo here to the podcast. Hey, thanks for having me, shannon. I'm excited to be here and discuss a little bit of what I do clinical trials in our practice.
Speaker 2Yeah, you're really making a difference and I think that's what you know, dr Sorreo, and I really want to highlight today. You know that clinical trials are really important. They're the foundation, you know, for medications and devices and all the things we want to offer patients to move forward. So if you've been prescribed something or your docs maybe recommended a particular treatment, this is where it started. So I really want Dr Sreya to kind of open up the conversation and just really explain you know what is a clinical trial?
Speaker 3Yeah, shannon. So in medicine we still have some unmet needs, right, and clinical trials are research studies that are really developed to test, manage and treat various health conditions, and these health conditions have an unmet need. The goal, though, with these trials is to understand disease states better and advance tests and treatments for these disease states, and, in derms, some of these disease states that come to mind are alopecia areata, hydradenitis superativa, atopic dermatitis, psoriasis, right, so diseases where we have some therapies, but we're just haven't really maximized the benefit we can give to our patients.
Speaker 2And I think that's where we're kind of coming up with. You know, there are patients, like you said, that something's working for there's a treatment. But I know some of you listeners out there, you know, as one of the things we have to think about that maybe you've tried some of those treatments that are the latest and greatest and you're like, hey, what's next? And that's really what we're getting at. That's where clinical trials start. But what you may not realize is that there's different types of clinical trials, and so I'm gonna let Dr Sreya, just kind of explain that a little bit because I think it is confusing.
Speaker 3Do you mind going over that a little bit for us? So, shannon, I think of clinical trials. I think of two kind of main broad categories, and I think of clinical trials as being like observational trials or interventional trials, in the different phases of clinical trials too. So let's briefly get into these. So interventional studies are what we typically utilize at our center and what an interventional study does is it tests or tries out an intervention, and that can be a potential drug, a medical device, an activity or procedure in people, so in human beings. This is commonly referred to as like our clinical trial Now, observational studies, on the other hand, they don't test potential treatments. Instead, researchers observe, like participants on their current treatment and see how they do over time. They plan and track health outcomes. So those are the kind of the two main types of trials I think of. And then there's the phases of trials, right? So trials go into preclinical development, and this is where you think of like the benchtop, and then that transition into like the clinical setting, and this is where you think of like the benchtop, and then that transition into like the clinical setting and at the benchtop at a clinical center, at an academic center. We think of like pipettes and we think of like non-human subjects, right, where those are like primates or whether they're rats et cetera, kind of really preclinical testing for safety of these drugs and potentially to see why they may work from an immunopathologic standpoint. So why would they work in humans? Then they get past preclinical testing and that's where centers like ours can really take, can really kind of where centers like ours can be a benefit.
Speaker 3So, phase one trials let's talk about these first. These are trials that we don't typically do. These are small trials and they're primarily concerned with establishing a new drug safety. So not as the drug work. Is it safe in small, healthy populations? These aren't patients with the disease state, these are healthy volunteers. You're going to test the drug on it and see how it does, right? How is the drug absorbed, how is it distributed, how is it metabolized? How is it excreted? How does the human body deal with this drug? All right, these are called pharmacokinetics. Then a drug can advance on to phase two. Okay, and about like, nah, about maybe 25, 30 percent will go on to phase two. All right, to make sure they're these small, healthy individuals tolerate the drug well and it's appropriate to go on. Then, once in phase two, this is where centers like ours really pick up and we participate in these trials. So phase two trials are where these placebo-controlled trials you may have heard of those words start to really come into fruition.
Speaker 3So we look at a drug and we want to determine if it's effective and if it's safe for a particular disease state with smaller numbers of people than like phase three trials, so a hundred to 200, a hundred to 300 volunteers. And then we want to ask the questions does drug X like improve the disease we're treating, right? Does it help? Does it give some sort of benefit above what's available currently? So not benefit in general, but benefit above what's available right, because we have lots of drugs, say like psoriasis, but you're not going to develop a drug that works not as good as what's available right. So you want something that works better than what's available Makes sense, yeah, yeah. The second objective is to see like what's the right dose and what's the right like frequency of dosing right, so you right dose and what's the right like frequency of dosing right, so you might test multiple doses out, see what works best for the disease state you're, you're at hand. So once that's answered, and if the drug is is effective, and of course looking at safety, if it's safe, then the drug will advance into phase three and only about like 30 percent of trials make it past phase two, right?
Speaker 3So phase one, looking at safety and healthy volunteers. Phase two, looking at efficacy and safety in patients that have it, as he states. And then phase three are these studies you're most kind of comfortable, most familiar with. These are the studies that are conducted at multiple centers, several hundreds of thousands of patients with whom the drug is tested, and we have massive testing of the drug to make sure this drug is safe and effective. And that's the whole point.
Speaker 3And these, these studies tend to be randomized, meaning that when you enroll on one, you're either given the drug or a placebo, or like a vehicle, we say in topical treatments, by chance, right? So you're either going to get the drug or not, and that is all randomized by chance. So you don't choose where you go. You either get the drug or get the vehicle by chance. And then phase three trials will then advance over time and that's the data you see in a phase three trial is we're going to see the labeling and the packaging. If it's FDA approved, okay, and about one in four drugs makes it. So one in four drugs that exits preclinical testing makes it through phase three for submission to the FDA. And once it's submitted to the FDA, now about like 20% of drugs get approved. So again, not all the drugs are going to get approved for these disease states, but that's kind of how they advance along.
Speaker 3So what you can tell a patient or what you can think of as an individual with a disease that's thinking about going into a clinical trial is, the further along in development these drugs are, the more and more safety data we're getting and the more and more efficacy or how well the drug works data we're getting.
Speaker 3So if you enroll in a phase one trial, that's a little more of a risk than enrolling in a trial that's in phase three, for example. So those are the three main phases. There is phase four. In phase four, studies of drugs are typically already approved for use. We see how they behave or how effective they are and how safe they are in real-world clinical practice. So those are phase four studies as well. So again, the further along you get in phases, the more safety you see and the more efficacy you have in a drug, so there tends to be less risk associated with being in that trial. But keep in mind though, these are clinical trials phase one, phase two, phase three and before they're approved by the FDA, there can be risks that we don't know about.
Speaker 2So you have to kind of keep that in mind when you're going to perhaps want to volunteer yourself into a clinical trial. I think that's fascinating. We went through a lot of information but it is important. I think you did a great job sort of outlining that, just to kind of explain to people and that simple, just rule of thumb the further along in that clinical trial, like you said, the more we know about safety, potential risk and efficacy.
Speaker 2Because I think that is one of the things you know we sort of see now especially myself, being newer to clinical trials as an investigator is just, you know a little bit of, you know, reluctance or there's a little bit of suspicion. You know, I think a little bit of that fear, especially post-COVID. We've all seen it in health care, where you know the public, many of our listeners mean trusting the healthcare system, doctors, insurance We've seen that decline, unfortunately, over time. So what would you say, you know, to a patient that's thinking about you know why should I participate in a clinical trial? You know what's the potential value to me or maybe to the greater good?
Speaker 3Right.
Essential Benefits of Clinical Trials
Speaker 3So you kind of hit the nail on the head with both of those. So there's a greater good contribution, right? So with more patients being studied within a disease state, we get overall understanding of how the disease behaves. So, for example, the more patients that we have in clinical trials for, say, a disease state such as eczema or atopic dermatitis, the more we understand how atopic dermatitis behaves. And this is because there's two things that happen. Either a drug is developed doesn't work. It's like, hmm, that's not how atopic dermatitis kind of behaves, because that pathway, that drug just didn't work. And then we see a drug that really is gangbusters as well and like, oh, this is kind of onto something here. You know, so this pathway is really relevant to atopic dermatitis. And the only way we know that is from real world data. Right, and by real world I mean like clinical trial data. Drugs are tested in controlled environments on human subjects.
Speaker 3The second thing is we're advancing treatment development, which we talked about. So, again, potentially better therapies than those that are currently available. We have to fill an unmet need, okay? So this can be that you've tried everything out there and it's not worked for you with your disease state. This can mean that you are a certain age that the drug's not approved for, right. So say, you're like eight years old and you have a condition where you know your child or your loved one's eight years old, or they have a condition that has no effect of therapies.
Speaker 3But there's something available for someone. That's an adult, right, that's an unmet need. So, again, you're trying to like, advance the therapies, advanced disease understanding. And then, finally, it's potential for personal benefit right, you can help yourself or you can help like a loved one, um relief from their disease burden. So those are the two main categories, those are the two main reasons you would do this right, help the greater good. And then, of course, like, help yourself. Like if you, if your disease is controlling you and you're not in control of your disease and nothing's helped or nothing's available, then a clinical trial might be right for you. So it's like an alternative treatment option when these standard therapies, like, just aren't accessible or not helping you.
Speaker 2So, rocco, I think that was a great summary you really highlighted for us. You know how doing a clinical trial can benefit the patient individually but then also contribute, like you said, to the greater good or to healthcare as a whole, to really help us find good treatments. And then also, I think, on the flip side, maybe help us eliminate treatments we thought might be good but maybe in the end don't work as well as maybe what we first suspected. And I think a lot of people wonder. Then you know, if these clinical trials are available, who's sort of behind the scenes, you know, sponsoring these, like who's responsible for bringing these to your office, to my office or to institutions to actually make them happen?
Speaker 3Yeah, so in 2024, the majority of clinical trials are sponsored by pharmaceutical companies. So pharmaceutical companies are investing in drugs and therapies to provide benefit for an unmet need, right, so that's the majority of the dollars are from pharmaceutical companies. There are, though, government grants that provide funding for some studies, but the majority are pharmaceutical companies. But there's oversight, right. So it's not like these pharmaceutical companies can test us and test patients like guinea pigs, right? You're not out there and you're not just being tested haphazardly.
Speaker 3There's oversight right, and institutional review boards, or IRBs, provide oversight to protect the rights and welfare of human research subjects in trials. So it's independent organizations that are monitoring the safety and welfare of every single subjects in trials. So there's independent organizations that are monitoring the safety and welfare of every single person in a trial. So keep that in mind, okay. So, first of all, companies may sponsor it, but they certainly don't have a say in how the trial is being conducted. Okay, it has to be conducted in accordance with declarations that protect your rights as a human research subject, and IRB is that body that's independent of the company, the pharmaceutical company that oversees the welfare and, again, the rights of the human subjects.
Speaker 2So you mentioned, you know just previously we talked about the IRB, the Institutional Review Board helping really keep us those high ethical standards and I think it leads to the patient always asking you know and coming to me when they've looked at maybe going into a clinical trial. You know, how am I protected? So how do you explain to patients that they are protected? There are safeguards in place to really ensure that they have you know coverage when they're in a clinical trial and that the trial is being held to a high ethical standard.
Understanding Clinical Trial Participation
Speaker 3Yeah, that's a great question, Shannon. So research is highly regulated, and the risk safety of the participant is the primary ethical consideration of all trials. Now, in order for a study to be conducted, safeguards have to be in place, including this approval we talked about by an institutional review board. Now, the institutional review board does protect the safety and rights of the patients, but then again, so does the principal investigator at the site, ok, and so does the FDA. So the FDA also has oversight over a trial too, and the sponsors, the pharmaceutical companies, hire organizations as well to make sure the study is being completed in a manner that is consistent with the informed consent or with the process that the subject or patient or yourself in a trial agree to. That brings us to the informed consent, though.
Speaker 3So what the informed consent is? It's a document that reviews the study entirely. It gives you, as a potential participant okay, entirely. It gives you, as a potential participant, okay complete understanding of the trial, the ins and outs of the trial. The investigator study staff are always available to answer any questions you have about the trial design, about the conduct of the trial, the whole time you're in the trial and if, at any point, you want to exit the trial. You certainly can Remember. Clinical trials are elective. You can enter them at your own, due to your own, because you want to exit the trial. You certainly can Remember. Clinical trials are elective. You can enter them at your own, due to your own, because you want to, and you can exit them because you want to. No one can keep you in a trial Right.
Speaker 3And so the ball's like kind of in your court.
Speaker 2I think that's really good. You highlight that because I think it's that concept of you know, like you said, informed consent or or sometimes we call autonomy that the patient, you're ultimately in the driver's seat and just because you agree to participate in a clinical trial, I mean you can withdraw at any point in time if you changed your mind. And I think people just understanding that freedom, all those protections that we've mentioned so far that are in place, could help give some reassurance or make people feel comfortable, maybe considering if it's the right choice for them, if they're kind of thinking about that in your office or you know if you had somebody out there that's listening that might even not even for a skin condition, but maybe they're looking at, you know, cancer treatment or something else that's going on in their life for a clinical trial. What types of questions would you tell the patient to maybe think about before they consider participating in a clinical trial?
Speaker 3Yeah, so one thing clinical trial. We look at the risk and benefit of going to the trial, right. What interventions are currently available for me and are those interventions what's right for me, right? This is all about the shared decisions. So you have to talk to your provider and you have to look at your goals and expectations as a patient and that provider needs to use Stereo2Care right their expertise, and you have to handshake and if there's nothing out there that you find is right for you and your clinician or your provider finds it right for you, then there may be other options available through clinical trials. Right, and a lot of these things are investigational. So keep in mind these therapies may or may not work all right. So I would say, when you look at like standard of care, typically it's what's available at that time and if nothing is right for you, then consider a clinical trial, right. Or if nothing is available for you, then maybe consider a clinical trial.
Speaker 3I do find some resources available to kind of look into clinical trials and you can kind of see what certain criteria are to meet and be able to participate in that trial. One website is trialtstodayorg. I was actually looking at it today and what's nice about trialtstodayorg is it allows you to put it in Z state so say you have let's just put down psoriasis, and then it asks for your gender, so your gender assigned at birth, so if I put male, and then it asks for your age, and then it asks for your zip code, that gives you a radius of search, and then you do that and you can find. You know, within your area there are X number of trials listed. Then you kind of read basic criteria.
Speaker 3You know what do you have to, what inclusion and exclusion criteria are there. So what things do you have to meet and what can you not have? To be, maybe, a participant? Then it gives you contact information so you can call that center and then you can talk to their research team and see if that trial may be right for you. We also want want to do, though, is loop in your family doctor, your providers, that you know, your healthcare team, if you're even considering a trial, and then, if you do go to the trial, you want them to be looped in as well. So, again, this is like using the whole healthcare team to help better your overall health, and a trial can sometimes do that.
Speaker 2And in the last couple of minutes we have. I think one of the things patients always ask is I don't understand what placebo versus open label means, and when the trial ends, if by chance I did get the medication, will I still have access to it, especially if it was working for me? How would you explain the possibility that may happen?
Speaker 3I know it can vary per trial, obviously yeah, yeah, so we talked about those phases, phase two and phase two trials. Typically these trials are going to you're going to get the investigational product we call that ip which is the drug under investigation or the therapy under investigation, the intervention under investigation versus a placebo and a placebo is a substance or treatment with no therapeutic effect. Okay, but you don't know what you're going to get. You could get the drug that has a potential therapeutic effect the investigational product or you may get the placebo. Sometimes, if you're doing a topical study, it's called a vehicle and all that is. It's what the investigational product would be in. So, for example, if it's like a petroleum-based ointment, you would get the petroleum-based ointment and not the active ingredient. So you're either going to get the placebo or the investigational product, or, like the vehicle investigational product and at some point in that trial, typically like at a certain week okay, if you were unlucky enough to receive the placebo or not the active drug, you're going to be switched over, typically to receive the active drug. So you know, if I can make it X number of weeks, I know past that time point I'm going to be on the therapy that's being studied. You don't know if the therapy works or not, but you're going to be on that therapy.
Speaker 3Another thing to keep in mind is when a trial is being conducted, say the trial. Let's put a number out there is going to be 300 weeks. During that trial there are committees meeting. They're assessing the safety and efficacy of the drug to make sure that it is meeting certain criteria. So they wouldn't have a study for a drug that doesn't work go 300 weeks. They're going to do cuts of data during that time period to see if it's worth continuing the trial. So you're not going to be stuck for 300 weeks with a drug that doesn't work. They're going to know at a certain time point whether the benefit's being afforded or not. So you're not out that long.
Speaker 3Also, can you get the drug? So say, the therapy works and the trial's wrapping up. So it's hitting week 300. Do you still have access to that drug? Well, it's not a clear-cut answer here, right?
Speaker 3Some drugs are FDA-approved before the trial ends and if you have access to that drug, typically you have to have some sort of commercial insurance or the drug company has certain grants that can provide you access. Yes, you can continue. If that drug is not FDA approved, you probably won't be able to get that drug, even if it worked on you, until it becomes commercially available If the trial ends. That tends to be uncommon. If a trial is ending and the drugs don't have to be approved, typically that drug probably has low chance at that point of actually being approved. Now, open label is what I talked about. It's kind of after that time point when you run placebo, you know you're going to be guaranteed some sort of drug. At that point in your mind you're going to get it and either the trial becomes unblinded meaning everybody's getting the drug and we all know who's getting what or remains blinded. But patients may be on different dosing arms, so someone may be on high dose, someone may be on low dose. We know they're on active therapy beyond a certain time point.
Speaker 2That's a great summary. I think, to be honest with patients, you know, because I think that's one of the questions I always have is am I going to get the medicine or not? And I know clinical trials maybe not our sexiest topic. I know here on the podcast a lot of people are thinking, hmm, why are we doing this? Well, it's really the foundation of medicine and where we move forward, whether it's dermatology and studying skin conditions and skin diseases that we need treatments for or other areas of medicine. So I hope that gave a broader understanding to everyone out there about the clinical trial process and maybe you'll consider it if it's something that's right for you.
Speaker 2But I want to thank Dr Sperer for coming on giving a great summary of clinical trials for us and hopefully again, some of you out there will convince yourselves it might be the right fit for you or for somebody else to contribute not only to the greater good of medicine but also for yourself if you have a tough condition out there and treatments have been exhausted. And also if you're looking for Dr Sorreo he's kind of a ghost on the social media front, but you can find him at docsdermgroupcom. He's a part of Docs Dermatology, so check him out there. And again, dr Sreya, thank you so much for coming on the podcast.
Speaker 3Hey, thanks, Shannon. It's exciting to be in dermatology. If you look at HS alone, there's over 170 clinical trials ongoing for HS right now. Right, Huge unmet disease, a huge unmet need right In this disease state. So, again, if you know someone that's suffering with it, if you're suffering with it, your patients are suffering with it and you're wits and don't know what to do. And I think we all have HS patients in mind, right, you know you can find a trial for them, right, or a potential trial for them to maybe alleviate some of that burden of disease. Right For this disease state that has a huge unmet need. So, and that's one disease state amongst many in Durham. So we're kind of blessed in Durham that we have a lot of innovation happening and these clinical trials can really help our patients and ourselves like keep abreast of, like the cutting edge developments that are happening.
Speaker 2Well said, I couldn't say it any better. Stay tuned for the next episode of Dermot Trotter. Don't swear about skincare.
Speaker 1Thanks for listening to Dermot Trotter. For more about skincare, visit DermotTrottercom. Don't forget to subscribe, leave a review and share this podcast with anyone who needs a little skincare sanity. Until next time, stay skin smart.
