This episode breaks down the foundations of academic clinical research, from how studies are conceived and funded to how protocols ensure rigor, consistency, and patient safety. Listeners learn about the roles of sponsors, CROs, IRBs, and research teams, as well as the advantages and challenges of conducting trials in academic settings.

This independent medical education program is supported by Incyte.

Please click here for a complete list of disclosures.

Episode One APPROVED.mp3

Transcript

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

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

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.

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

I'm so glad you're here.

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

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

Today is the first episode in a three-part series exploring the world of clinical trials.

In this conversation, our expert panel breaks down what makes academic clinical research unique, why clinical trials matter, and how studies move from idea to a fully executed protocol.

You'll hear insights

to the roles of sponsors, CROs, IRBs, investigators, and research terms, along with the advantages and challenges of conducting trials in academic versus non-academic settings.

I'd like to introduce your host and moderator for the next three episodes, Dr.

Thy

Huynh.

Dr.

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

She is also the director of clinical trials in dermatology.

So thank you so much for stepping into the host seat.

Dr.

Huynh, I'll turn it over to you.

Thank you, Jenn.

Joining me is Dr.

Jason Hawkes and Dr.

Jeff Sugarman.

I'll give them a chance to introduce themselves and briefly summarize their clinical trials experience.

Dr.

Hawkes, why don't you get started?

Yeah, thanks for having me.

I'm Dr.

Jason Hawkes.

I'm a board-certified dermatologist.

and the co-owner and chief scientific officer and investigator at the Oregon Medical Research Center in Portland, Oregon, where we primarily run clinical trials.

We run about 40 clinical trials at any given time.

And previously to this, spent most of my time in academic dermatology and excited to be here and have this fun discussion.

Dr.

Jeff Sugerman.

Thank you so much for having me.

I am a board-certified pediatric dermatologist.

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

I participated in over 100 clinical trials as both a principal investigator and as a medical monitor.

I'm also a volunteer clinical professor at UC San Francisco in the Department of Dermatology and Family Medicine.

Welcome, welcome.

We're going to spend the next three episodes talking about clinical trials, and we'll hopefully pick up some pearls, learn how to avoid common pitfalls along the way.

Let's focus on what makes academic clinical research unique and why it matters.

So, Dr.

Hawkes, what defines an academic clinical trial to you?

You know, I wouldn't traditionally put academic before a clinical trial because I think academic kind of communicates the

clinical trial occurring at a particular location.

But a clinical trial is, to me, really the chance where we get to apply the same rigors of science to medications and patients.

So for those of us that have spent time in laboratory benchtop research, we're using artificial systems.

But the clinical trials are a formal way.

that's organized to actually test therapies or test ideas in humans with specific diseases.

And these can occur, obviously, in academic centers, but also in private clinics or even healthcare systems.

And this gives us a chance to get objective evidence so that we can inform the

the decisions we are going to make with regards to treatment, but also it's the basis for decisions that patients can make as to choosing therapy A over B versus C.

Just to dovetail on what Jason just said, many clinical trials actually have sites in academic centers as well as in private practice.

So you can have one trial with both.

academic and non-academic sites participating.

And in fact, in my experience, many clinical trials are set up that way.

And Dr.

Sugarman, how do you find that these studies become initiated?

What's the starting process?

The first thing that happens really is that the sponsor of the trial has to hire, usually, a CRO or clinical research organization to help them run the trial.

So usually a sponsor isn't doing that themselves, but it's better if they have sort of an arm's length distance from the trial, so there's not a perception of bias from the sponsor.

So if you have a pharmaceutical company, A, for example, and they're running the trial and making decisions, you know, about who's, you know, doing what, there may be a sense that they're manipulating

things.

And so the standard these days is to have a middle body, a clinical research organization or CRO, that actually runs the trial.

And how are these trials funded and reviewed in the academic settings?

Dr.

Hawks, can you give us some viewpoints on that?

Yeah, and Jeff's...

you know, introduced the, what we see is the traditional trial mechanism where most of these are actually sponsored or funded by pharmaceutical companies or even early startup companies.

But there are other mechanisms as well, which gets to sort of the, you know, how they're set up and sort of how they work.

But we have investigator-initiated studies.

These are studies that, you know,

Dr.

Sugarman or myself could say, hey, I have an idea and I want to design a study and test in patients and run it at a site.

We could do that with a small group, a collaborative group of sites.

And you can also do studies that don't have interventions.

So that could be simply observing a natural phenomenon.

So those are funded in different ways.

Those might be funded by academic centers or research organizations like PGO or the National Psoriasis Foundation, for example.

But once the trials get set up, once they're funded, it's, you know, following a recipe.

I always talk to our patients as

of a recipe for what the study looks like.

And we all try to follow that same protocol.

And that helps keep consistency across sites.

It helps have predetermined measures in a clinical trial so that you don't run the risk of a group not getting the result they wanted and trying to change after the fact.

So it gives you the transparency, the honesty,

These usually result in publications, most of the time for positive trials, but occasionally in negative trials where maybe a particular therapy didn't work.

And that's also informative to a clinician making a decision about a therapy when they have other options.

So these are sort of some of the ways that after the funding, the process of the trials, you know, get conducted and go on.

So Dr.

Hawks, can you give me an example of what some of these recipes would look like?

So a good example, if we take, let's say, psoriasis, for example, in the study protocol, there's criteria that these patients need to meet in order to qualify for the study.

We call those the inclusion criteria.

And then there are exclusion criteria, which are criteria that they can't have or excludes them from the study.

Before the trial starts and is designed, we're setting up those criteria so we know what's the study population we're looking at.

Is this kids?

Is this adolescents?

Is this adults?

Is it a combination?

Is this an interventional trial?

Is this a trial where we're giving a therapy or are we comparing it to placebo, for example?

And is it multicenter?

Does it involve multiple sites?

So the protocol is predetermined, it's approved.

usually by a regulatory body, so like here in the US, like the FDA.

And that's going to be the approved set of rules, if you want to think of it that way.

That's going to determine how the study is conducted, but also how we handle things like adverse events or side effects or prohibited medications.

Some people get sick, some people need surgery or have accidents.

So this is really the book that we can follow throughout the study, and it keeps all of us on the same page.

Thank you.

So I'd like to kind of highlight some things.

You know, you mentioned a very controlled setting, and as a principal investigator to run a clinical trial, you would definitely need a seasoned team.

Dr.

Sugarman, can we discuss some of the team establishments, such as the research coordinator, a regulatory specialist, and even maybe what the role of a medical student would be on a clinical trial?

Probably the most important person at your site is going to be your study coordinator.

And in large sites like Jason's, Dr.

Hawk's site, there are going to be multiple study coordinators because a study coordinator can really only handle two or three studies at a time.

That's the person that really is going to know the protocol inside out.

He or she will be responsible for helping with recruiting and making sure that

the refrigerators are working correctly and that, all those little details are happening.

And so without a really good study coordinator, it's really almost impossible to run a good clinical trial.

And so, they'll make or break you basically is what we say in the industry.

So that's the main, the most important sort of central person.

The principal investigator would be someone like Dr.

Hawks or myself.

You might have a busy site with sub-investigators, and that can be another physician or dermatologist or a mid-level, even a nurse practitioner or a physician assistant.

Then you might have other assistants that help with the trial, like that aren't going to be blinded.

For example, you know, sometimes the way the study medicine is dispensed

There are some people that are going to have to be completely blinded and there are other assistants that may not be, but might not, you know, be in that case, in that case, they wouldn't be exposed to the study subject.

But so you're going to need ancillator personnel behind the study coordinator as well.

Dr.

Sherman's right on that the study coordinator has to be your source of all information.

These protocols can be

150 to 200 pages.

There's a lot of detail and you need someone to really know the ins and out of that.

And in addition to some of the people mentioned, we have a full nursing staff.

We have a phlebotomist.

So we have someone to draw blood.

Most of these study visits that usually occur most frequently about every four weeks requires blood draws.

Sometimes they have biopsies or, you know, tape strip testing when they're trying to do exploratory

research to try to discover new biomarkers or things that indicate aspects of the disease that will help clinicians.

We have front office staff to help with coordinating schedules and payments.

Most of the trial patients get paid, so we have mechanisms in the budget to pay these subjects.

And we have regulatory and financial individuals that help us.

The regulatory individuals probably right up there with our

also most important person because they're responsible for getting approval from the study.

We have to submit to an IRB, which is an independent group that monitors safety and ethical practices in clinical trials.

And most of the documentation we have also can be reviewed or even audited by the FDA.

So this kind of highlights the complexity of running trials.

It's

Probably there's a similar complexity to running a clinic.

You've got a lot of moving parts.

Teams have to work together and we're governed by a set of rules that are bigger than us as individual sites.

But doing so and bringing all these pieces together provides a mechanism

where patients can access care differently than our traditional system, where our healthcare system can be convoluted, it can take time, it can be expensive.

Waiting to see a specialist, if you have a specialist at an academic center, for example, could take six or nine months.

And some of these patients, even when they get to these specialized centers, can't always afford medications.

One of the big advantages to the system working together well at multiple places across the world is these patients can get access to very good therapies, very safe therapies at no cost and get paid for their visits and at the same time contribute to research.

So it's very important to view this as a mechanism of healthcare delivery that should be complementary

to academic centers or outpatient clinics.

This is another way of extending care to the greater population who might have some of these bothersome chronic conditions.

You've touched on a few points of the advantages of running clinical trials in an academic center.

You know, certainly the transparency is there and the role of collaboration with the multicenter sites and scientific independence.

Are there other advantages, would you say, that was there?

Dr.

Sugerman, do you have any comments on some of the advantages?

I mean, there's advantages and disadvantages in both systems, really.

Dr.

Hawkes mentioned the IRB, or Institutional Review Board.

So that's one aspect of a clinical trial that's going to be different in academia versus in non-academia.

Most academic centers have their own IRB.

And the non-academic centers have what's called a central IRB.

So it's a centralized IRB that multiple different sites can use.

It's much more efficient.

And usually the non-academic sites, for that reason, can get up and running for their clinical trial more quickly.

And in fact, academic centers sometimes complain

that a lot of subjects have already been enrolled by the time their site's IRB has approved the study, the study's almost closed.

And so that can be an issue because different academic centers feel like their IRB is the only IRB that can be used, and that's the IRB they trust.

And there's been a lot of conversation among

people at Pedra and other clinical researchers to try to loosen that up a little bit so academic centers can also use a central IRB.

It'll just make, it'll streamline the enrollment process greatly.

So that's one difference between doing a study in academia versus non.

There's probably more red tape in academia as well.

there's just a lot more scrutiny in terms of OSHA and CLIA.

I mean, everybody has to follow the same rules, but there are basic sets of rules that are set out.

And then there's institutional rules on top of those.

And every academic center has their own set of rules.

And sometimes they can be more onerous and time consuming than the general set of rules.

And you've definitely touched on the challenges with the slower timelines and administrative complexities.

I will throw a comment that my institution has both central as well as local.

So then they throw in both because they wanted to negotiate that to feel like there are choices.

But those are definitely things that are kind of cumbersome in this process.

As these processes evolve, is the conversation shifting from

setting specific differences to a broader emphasis on evidence generation and patient impact.

Clinical trial becomes, sets the standard for human evidence in making decisions.

I think that's, it's not the academic at all.

It's just that academics, you know, for many years sort of led this charge and

Now it's become privatized and more widespread and more readily available with central IRBs, et cetera, ending it.

I'd probably try to focus on that, it's changing, but not that one's better versus the other.

That's actually an important point because the way I said it, made it seem like it was a one or the other, and that's how it's been, but there's already change afoot.

So it's great to hear that there's some institutions that have both.

Thank you for this great conversation, and I'm looking forward to learning more in our next episode.

Thank you so much to Dr.

Huynhand Dr.

Hawks and Dr.

Sugarman for participating in this episode.

In this episode, we unpacked the core elements of clinical trials, from how studies are initiated and funded to how protocols are designed to ensure scientific rigor, transparency, and consistency across sites.

Our speakers highlighted the critical roles played by study coordinators, investigators, regulatory specialists, and supporting staff in bringing a trial to life.

We also explored the unique strengths and hurdles of academic centers, including regulatory complexities, IRB structures, and collaboration across multiple sites.

Ultimately, clinical trials, whether academic or private, serve as a vital pathway for generating high-quality evidence and expanding patient access to safe, effective therapies.

As we move into our next episode, we'll shift our focus from academic settings to motivations and dynamics of clinical trials conducted in private practice and industry environments.

Episode 2 explores how efficiency, patient access, and operational flexibility shape these trials and how they complement academic research to broaden therapeutic innovation.

Join us in Episode 2.

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.

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.

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, our Arcutis Biotherapeutics, Chiesi, Insight, Sanofi, and UCB.

And our bronze level supporters are DISC Medicine, Janssen,

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,

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.