00:00:00 Jenn Dawson

Hello and welcome to PeDRA Pearls, the podcast from the Pediatric Dermatology Research Alliance.

00:00:06 Jenn Dawson

We are a vibrant research community pursuing a mission to create, inspire, and sustain research to prevent, treat, and cure childhood skin disease.

00:00:16 Jenn Dawson

Each week, we bring you inspiring stories, research updates, and practical information to advance science that improves the lives of children with skin diseases and conditions.

00:00:27 Jenn Dawson

I'm Jen Dawson, host of PeDRA Pearls and PeDRA’s Director of Educational Programs.

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I'm so glad you're here.

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Before we jump into our episode, just a quick note.

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Full disclaimers will be provided at the conclusion of the episode and further information along with relevant links are available in the episode notes.

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Welcome back to the second episode of our series all about clinical trials.

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In this conversation, we explore the motivations, advantages, and real-world challenges of conducting clinical trials in private practice and industry settings.

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Our guests unpack how efficiency, patient access, operational flexibility, and financial considerations drive these trials, and how private research sites complement academic centers to broaden therapeutic development.

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So now I'd like to welcome back our host, Dr.

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Thy

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Huynh.

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Dr.

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Huynh is a pediatric dermatologist and assistant professor in both dermatology and pediatrics at the University of Mississippi Medical Center.

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So thanks so much for hosting our second episode.

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Dr.

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Huynh, I'll turn it over to you.

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Thank you, Jenn.

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I'd like to welcome back our guests, Dr.

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Jason Hawkes and Dr.

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Sugerman.

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Yeah, thanks for having me.

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I'm Dr.

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Jason Hawkes.

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I'm a board certified dermatologist.

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and the co-owner and chief scientific officer and investigator at the Oregon Medical Research Center in Portland, Oregon.

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Dr.

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Jeff Sugarman.

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Thank you so much for having me.

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I am a board-certified pediatric dermatologist.

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I'm the medical director at Redwood Family Dermatology, which is a fairly large multi-specialty dermatology practice.

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For this part of the conversation, we're going to focus on exploring the advantages and limitations

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of conducting clinical trials outside of the academic institutions.

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I'd like to welcome back our guests, Dr.

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Jason Hawks and Dr.

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Sugarman, and we'll get started with what motivates industry and private entities to conduct trials.

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Dr.

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Sugarman, can you take this question?

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Sure, thanks for having me back.

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Well, I think ultimately there's the financial incentive, I mean, companies

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invest a lot of money in drug development.

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It's a very expensive undertaking with a lot of risk because most drugs fail.

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They don't make it even to a phase three clinical trial, which is just sort of the last, you know, double-blinded, placebo-controlled

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event that needs to happen for FDA approvals.

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So it's a very high-risk endeavor and companies spend a lot of resources, a lot of time and financial investment.

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But ultimately, the end consumer is really the reason why we all do this.

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I mean, to have new therapeutics that are safe and effective for our patients.

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who have diseases that we couldn't treat effectively before is incredibly rewarding.

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And I think that really probably is the underlying motivation for most of us in the industry.

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But I don't think you can ignore the financial motivation as well.

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Dr.

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Hawkes, what do you find are the advantages of a private practice setting for trials?

00:03:48 Dr. Hawkes

Yeah, and I think first to just kind of build on a little bit of what Dr.

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Sugarman said, you know, he's right that, you know,

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This is a business, and for these companies developing these medications, they have to develop medications that work and that are going to be beneficial to patients, but ultimately bring in income.

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But some of the other aspects as to why we also see trials being done, it's a way to prove a hypothesis.

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Somebody might have heard that this particular drug might work for this condition for which it's not approved, and a company wants to ensure that

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It works.

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And also the clinicians want to see that rigor before they start to prescribe it to patients.

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And one aspect that's important with the purpose of trials is to have both new indications, right?

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Again, testing maybe old therapies in new diseases or even new therapies in old diseases.

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You might see a combination of that.

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But one of the real

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useful trial designs that we often see now are the head-to-head trials.

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And this gives us, in a controlled setting, the ability to see which drug, drug A versus drug B, or multiple drugs, overperform or outperform for a particular disease state.

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And that's really critical, I think, for most of the clinicians and patients, especially when they have a choice for therapy.

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But also, as we start to look at particular components, again, using psoriasis, there's drugs that are going to work better in joints versus the skin, and some that work better in the skin versus the joints.

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So again, having these comparisons helps us make informed decisions to help our patients, and it helps them in sort of pushing when maybe a particular medication is best for them.

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The comparison of the private centers like our site

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and we're privately owned just me and my partner and we have staff of about 20 individuals here what's the difference between what we do well as Dr.

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Scherman mentioned the trials are quite similar right we can participate in the phase three program again that late stage clinical trial and follow the same protocol as an academic center the difference for us is that

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We have a lot less red tape.

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We have efficiency that far surpasses what a lot of academic centers have.

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We can get trials up and running quickly.

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We can do it efficiently.

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We can often do it in a cost-effective way.

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So academic centers traditionally have higher overhead costs or what we call indirect costs.

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So our ability is to run the same trial.

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actually is quite a bit cheaper with regards to some of the overhead and the cost to the sponsor.

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We also tend to recruit patients faster.

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So when you start to compare the number of patients we might put in a trial versus an academic center, we often, in many trials, we've been one of the highest enrolling sites in the entire study protocol or study program.

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So it gives us the versatility

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What we don't have is the infrastructure and maybe some of the support and even some of the referrals that come with these big academic centers.

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So, we have our own challenges that are different, put us at a disadvantage in some ways.

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But overall, I think the combination of both academic and private centers

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gives the greatest flexibility, especially for patients who, as I mentioned earlier, may not even have access or be near an academic center.

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Like I'm thinking of where I grew up in Idaho, there's still not even a medical school.

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So what do you tell those patients or go to Montana or Wyoming, these more rural areas.

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So we need to extend the reach beyond academic centers and private centers like our own does that.

00:08:00 Dr. Sugarman

One of the advantages that an academic center is going to have is in the study of rare disease.

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So you might have a clinical trial that's starting on a rare disease like recessive dystrophic epidermolysis bullosa or something like that.

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And those patients are really few and far between, and they've all learned how to migrate to the regional academic center that specializes in that.

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So like in our area, Stanford has a center of excellence.

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in EB.

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And so those patients are there.

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So if you're going to do a clinical trial for a new drug for EB, my site is not going to recruit many patients, if any, for a trial like that.

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But if Stanford is a site, they have all of those patients that are already there that could potentially enter the study.

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So that's really where I see the academic center having a big advantage is in the study of rare diseases because they already had those patients.

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at their institutions.

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I 100% agree.

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And it's a very important point, especially for the Pedri listeners and even some of the pediatricians.

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We know that most pediatricians or pediatric derm in particular actually are going to coexist in an academic system.

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So that has a lot of truth to it.

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And I think as you get to

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those more rare diseases.

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Now, eczema, we could probably recruit very well through any of those areas.

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But yeah, I agree completely.

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And again, that's the reason for the one not being better than the other.

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You need both.

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You need these highly specialized centers.

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And then you also need some maybe higher volume, high throughput, private trial sites that can extend access.

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So this is really how do we work together better

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to really broaden the reach to those patients living with these conditions.

00:09:57 Dr. Huynh

And I do like those comments as the teamwork for both a private and academic center.

00:10:05 Dr. Huynh

I am the only pediatric germatologist in Mississippi, so I do see a lot of clinical trials coming through that are focused on rare disorders.

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And we still have atopic germatitis and psoriasis and hydratinitis to Pertiva.

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But as a starting principal investigator about four to five years ago, the ichthyocycloma disorders, the ED, the vascular malformation, and I actually got the ulas tentacle away.

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So there are good things on both sides.

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And so there are those advantages with efficiency.

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with patient access on the private side.

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But then on the academic side, you can get a little bit of a mixture of both.

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And with pediatric dermatologists, zebras are definitely a thing.

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And so, yes, I completely agree with you.

00:10:53 Dr. Huynh

Let's go to a little bit of the trade-offs as being part of the private practice side of clinical trials.

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We touched on one with, you know, the rare zebras being a case.

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What else do you think, Dr.

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Hawks.

00:11:08 Dr. Hawkes

As I mentioned, we don't benefit from the infrastructure of a big university system or an academic center that, you know, might have all the other specialties that can help refer and, you know, share those patients in the trial center.

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For example, when I was in New York City doing my primary research at Rockefeller University and also on faculty at Mount Sinai,

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You know, we had at the time probably pretty close to 100 affiliated dermatologists in that department.

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So if you were looking for a particular disease states or you needed help in kind of recruitment, you had that.

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In the private clinical trial centers, you may have an associated clinic or outpatient system.

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You may be part of a larger system.

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So you may get that in part, but I think those are some of the trade-offs.

00:12:04 Dr. Hawkes

In terms of ease, I think we at the private side are a little more nimble.

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I mentioned sort of a little more versatile as well.

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We can take on studies that might be higher risk and we can do those at lower costs in a lot of cases.

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So, you know, we tend to get approached by

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companies that often don't have academic centers where they don't necessarily need that expertise.

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The other trade-off for us is we lose the infrastructure of the research setting.

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So, I spent most of my career in that translational science and immunology.

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where we did things like biopsies and blood work that went to analyses that looked at genes or different signals of the immune system, which you call molecular profiling or expression profiling that might tell us certain aspects.

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Most of the academic centers have these translational cores, these research centers that are funded by the university and other mechanisms in the state, for example, that really give you the ability to answer a different question

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that we do have some constraints and limitations.

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We don't have the big budgets that some of these academic centers have.

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So those are functional differences between the two.

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I think industry and some of the companies have helped try to bridge the gap in that they're now bringing some of those research tools that they have in their own companies.

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to basically help these private sites to say, if you want to answer these questions and help collect the samples and bring in the patients, we can utilize our resources as a company, non-academic center, help answer those questions.

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So you're seeing these sponsors directly participate in the trial and generating data and partnering with both academic centers and private sites.

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So again, we're seeing this crawl towards a more decentralized

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more sharing, collaborative environment, as opposed to what we saw in our early careers, Jeff and I, in that these kind of research happening in silos.

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Now we're seeing these extended online networks that can work together.

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And that's important, again, for advancing science in different ways.

00:14:29 Dr. Sugarman

Another example of that might be a PK study.

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So those studies involve very frequent blood draws, sometimes in the middle of the night.

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A lot of private settings can't accommodate that.

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They may only have a nurse on staff or someone who can draw blood.

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from 9 to 5, and they can't do the 8 p.m.

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or the midnight draw, whereas an academic study center may actually even have a sleeping facility for subjects that have to spend the night who have frequent draws.

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So you might have a clinical trial set up where there's 40 sites, some of them are academic, some of them are not, and the PK sites might be a small subset of the total sites.

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And so there might be PK at just a few of those sites, and the sites selected may be

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either a bigger non-academic research center, they can accommodate that kind of PK study or more frequently in an academic setting.

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Yeah, great points.

00:15:24 Dr. Huynh

That's a really good real world evidence of how the two systems can really work in unison, especially with the PK studies.

00:15:33 Dr. Huynh

I've had to do a few that are 24 hours and being in an academic center was whole, but there's also third party vendors from some of these CROs.

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So, you know, with that

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With that in mind, Dr.

00:15:46 Dr. Huynh

Sugarman, can you discuss a little bit about a contract research organization versus a private investigator and how these recruitment processes work?

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Okay, sure.

00:15:58 Dr. Sugarman

As I said in the beginning in the last podcast, you know, most clinical trials...

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are going to run, the large ones that are funded by pharmaceutical companies are going to run through a CRO as a middle person to keep the sponsor sort of arm's length from the clinical subjects.

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There are investigator-initiated studies, as Dr.

00:16:19 Dr. Sugarman

Hawks pointed out, too, that don't need a CRO.

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I mean, there's small studies that, you know, someone has a good idea, they want to test it out.

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You don't really need a CRO.

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You just need a research infrastructure for that.

00:16:30 Dr. Sugarman

So it really depends on the type of study and how big the study is.

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But, you know, these big psoriasis and eczema studies and vitiligo now and alopecia areata, these are really large, multicenter trials that really have to be run through a CRO, as opposed

00:16:47 Dr. Sugarman

to, okay, we've got a JAK inhibitor that, you know, would this work for granuloma annulare?

00:16:53 Dr. Sugarman

I'm really curious about that.

00:16:55 Dr. Sugarman

Let's enroll 20 patients and, and try to find out, you know, an investigator, you know, might be able to initiate a study like that and take a known approved drug and try it out.

00:17:06 Dr. Sugarman

So very, very different scenarios.

00:17:08 Dr. Huynh

With that in mind,

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mind, being a private practice dermatologist, can I just start up a clinical trial?

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How would that setup look like?

00:17:16 Dr. Huynh

Dr.

00:17:16 Dr. Huynh

Halks, can you give us some comments?

00:17:19 Dr. Hawkes

You can, and there's nothing that would stop you from doing that.

00:17:23 Dr. Hawkes

It does take a level of experience and expertise.

00:17:28 Dr. Hawkes

So I think probably for a lot of these sites, and we've helped over the years, a few sites get up and running.

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One of my very good friends from medical school,

00:17:39 Dr. Hawkes

actually now runs a site in sort of the Midwest.

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And there's a learning curve.

00:17:45 Dr. Hawkes

When you conduct clinical trials, it's more than just knowing what the disease is and what the treatments are.

00:17:53 Dr. Hawkes

You're learning about a new therapy that you may not have ever used, which is the real advantage from my perspective being in clinical trials is

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You get an early jump on the medications that are not yet approved, but we can see the benefits so that when they do come out, we already have that experience and familiarity.

00:18:13 Dr. Hawkes

So you've got to learn new mechanisms.

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You have to work with different companies.

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So the way companies or these CROs conduct the trials can be different.

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The protocols can have different components that, you know, make it difficult.

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You have to build staff that has a very specific expertise.

00:18:35 Dr. Hawkes

So as Dr.

00:18:36 Dr. Hawkes

Sugar mentioned, the coordinators have to know what coordinators do.

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They have to create the paperwork and the charts for these patients.

00:18:45 Dr. Hawkes

We call those source documents, and many times you can be given those by the sponsor, but we tend to find they're not quite good enough that we like to sort of make them uniform, so we have to create the documentation.

00:19:00 Dr. Hawkes

You have to learn what's required from the FDA in terms of the regulations.

00:19:04 Dr. Hawkes

There are a lot of rules that govern how you conduct trials.

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When do you start seeing patients?

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When do you not see patients?

00:19:11 Dr. Hawkes

We get into government acronym chaos and soup, where you have to learn what a 1572 is.

00:19:21 Dr. Hawkes

You need to learn what the DOA is.

00:19:24 Dr. Hawkes

You start to learn all of these aspects that are going to be overwhelming.

00:19:30 Dr. Hawkes

So I don't typically recommend someone to just go and start a trial center.

00:19:35 Dr. Hawkes

I recommend really getting some hands-on experience where maybe you're in an infrastructure or already in an established center.

00:19:44 Dr. Hawkes

and then start to learn some of these principles and the general flow.

00:19:48 Dr. Hawkes

when I was in my master's of clinical investigation at Rockefeller University, Jim Krueger was really the leader in immunology research behind plaque psoriasis, let me as the chief scholar just run a trial.

00:20:03 Dr. Hawkes

and said, Here you go. I don't want to do it, but it's important, so why don't you take it? And that was a chance for me in a controlled setting with mentorship and help to sort of get my, dip my feet in the water, if you want to think of it that way. And I think that's a good starting point. So I think having some good mentorship, having a collaborative network that you can ask questions and kind of run some things by and start to get

00:20:30 Dr. Hawkes

what the knack is for trials. I always tell people that ask me, like, what if I start my own center? I'd say, you know, clinical trials aren't for everybody. They're different. They are much less, they're more stringent or regulated than outpatient clinic, where in outpatient clinic, you can play mad scientist. Like, I have no idea if this is going to work, but I'm going to try to help you. You can't do that in trials. We have this artificial environment where there's prohibited medications, and we talked about the inclusion and exclusion criteria.

00:21:01 Dr. Hawkes

And we can't mix and match. We can't use things in combination. So you have to get comfortable with that, knowing that you have these constraints that you don't normally have in, you know, a traditional care setting like an outpatient clinic or an academic clinic. So it's not advised to just try to jump in that way without some good help. But we've seen sites do it, and we're seeing more private sites possibly.

00:21:30 Dr. Hawkes

pop up across the U.S.

00:21:32 Dr. Sugarman

I would just add to that, I think one very practical way, if you really want to get started in clinical research, is become a sub-investigator or an SI. So you team up, you're working in a trial center, either academic or private, and you're not the principal investigator, you're the sub-investigator, and you'll learn

00:21:53 Dr. Sugarman

the ins and outs of doing the trial, you basically form, you know, perform like a principal investigator, but you're not ultimately responsible. That's a great way to cut your teeth and learn, you know, how to really do a clinical trial. And, you know, you do 5, 10, 15 of those, and then you're a lot, you have a lot

00:22:13 Dr. Sugarman

broader skill set to become a principal investigator. And then at some point, if you wanted to run your own trial center, you'd have a lot more experience to do that.

00:22:23 Dr. Huynh

Well, thank you for this great conversation. I'm looking forward to learning more in our final episode.

00:22:29 Jenn Dawson

Once again, thank you so much to our host, Dr. Thi Huynh, and our guests, Dr. Jeff Sugerman and Dr. Jason Hawks.

00:22:36 Jenn Dawson

In this episode, we examined the landscape of clinical trials outside of academic institutions, highlighting how private practice sites bring speed, efficiency, and expanded patient access to research.

00:22:48 Jenn Dawson

Our speakers discussed the financial and scientific motivations of industry partners, the unique strengths of private sites, and the trade-offs that come with conducting research without the infrastructure found in large academic centers. Together, these perspectives underscore why both private and academic sites are essential to advancing innovation and ensuring patients across diverse communities can benefit from emerging therapies. It's also worth noting that academic and private trials aren't so different after all.

00:23:18 Jenn Dawson

As we move into the final episode of our series, we'll shift our attention to the collaborative power of academic centers and private industry working together. Episode 3 explores how these partnerships strengthen patient care, expand research capabilities, and drive innovation across the clinical trials system.

00:23:36 Jenn Dawson

We'll see you back in episode 3. It's important to note that the views and information expressed during this podcast do not necessarily represent those of the Pediatric Dermatology Research Alliance or the program guests. The purpose of this podcast is to be thought-provoking and to stimulate new ideas, new collaborations, and novel research.

00:23:55 Jenn Dawson

Any reference to medical treatment or disease management is for this purpose only. It is not an endorsement by PeDRA and it is not a substitute for medical advice, diagnosis, or treatment. Any decisions related to medical care should be made in consultation with a qualified healthcare provider. For a complete list of guest disclosures, please click the link in the episode notes.

00:24:16 Jenn Dawson

This independent medical education program is supported by Insight. I would also like to take a moment to thank Pedra Corporate Council members. Our gold level supporters are Eli Lilly and Sanofi and Regeneron Pharmaceuticals. Our silver level supporters are AbbVie, Abeona Therapeutics, Arcutis Biotherapeutics, Chiesi, Insight, Sanofi, and UCB. And our bronze level supporters are DISC Medicine, Janssen,

00:24:45 Jenn Dawson

and Pfizer. We so appreciate their shared commitment to Pedra's mission as members of the Pedra Corporate Council. If you enjoyed this episode, be sure to follow us or subscribe to the Pedra Pearls Podcast channel wherever you listen so you don't miss future conversations. To learn more about Pedra and our work to advance research in pediatric dermatology,

00:25:08 Jenn Dawson

visit pedraresearch.org or follow us on social media @Pedraresearch. Until next time, keep listening, learning, and collaborating to make a difference for kids with skin disease.