The Scope of Things

Episode: 47 - Joseph Kim on Pragmatic Solutions to Age-Old Problems

• Clinical Research News • Season 1 • Episode 47

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Joining this month’s episode of The Scope of Things is Joseph Kim, chief strategy officer of ProofPilot, who talks about his company’s first-ever CORE Symposium, where pharma pros shared practical solutions to age-old trial challenges. Kim provides a pragmatic viewpoint on the problematic trio of clinical trials—study execution, recruitment, and engagement—and what change agents are needed to pave the way forward and find an exit from the bottlenecks. Plus, host Deborah Borfitz delivers the latest on a planned mapping of clinical trial deserts, the high cost of accelerated FDA approvals, the best states for cancer research, the world’s first in-ear EEG system getting approved, and a new smartphone-based outcome measure for sleep studies. 

 News Roundup 

Financial hurdles to trial enrollment 

  • Study in the Journal of the National Comprehensive Cancer Network 
  • News on the Case Western Reserve University website  

Accelerated cancer drug approvals 

Best states for cancer research 

  • Blog on SmileHub website 

In-ear EEG devices 

  • Article in Diagnostics World News 

Ecological momentary assessment in sleep-focused trial 

  • Study in JAMA Network Open 

  

Guest 

Joseph Kim, chief strategy officer for ProofPilot 

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

Deborah Borfitz:

Hello and welcome to the Scope of Things podcast, a no-nonsense look at the promise and problems of clinical research based on a sweep of the latest news and emerging trends in the field, and what I think is worthy of your 30 or so minutes of time. I'm Deborah Borfitz, Senior Science Writer for Clinical Research News, which means I spend a lot of time with my ear to the ground on your behalf, and a lot of hours every week speaking to top experts from around the world. Please consider making this your trusted go-to channel for staying current on things that matter, whether they give us hope or cause for pause. In a few minutes, I'll be speaking with Joseph Kim, Chief Strategy Officer at Proof Pilot, about the takeaways from its first ever core symposium, where pharma pros shared practical solutions to age-old study execution challenges. But first, the latest news, including the planned mapping of clinical trial deserts, the high cost of accelerated FDA approvals, best states for cancer research, approval of the world's first in-ear EEG system, and a new smartphone-based outcome measure for sleep studies.

Deborah Borfitz:

A new study out of Case Western Reserve University has identified financial barriers as the biggest hurdle preventing cancer patients from enrolling in potentially life-saving clinical trials, overturning long-held assumptions that race or demographics is the main culprit. The conclusion was drawn from an analysis of the electronic health records of more than 12,000 cancer patients, finding income, property, ownership, and financial stability were the most powerful factors determining enrollment. This means that addressing real-world participation costs like transportation, child care, and lost wages, could make research more equitable. A larger study publishes soon that integrates clinical trial data with a state cancer registry to produce a comprehensive map of clinical trial deserts. Researchers looking at new cancer drugs granted accelerated approval by the FDA found they have provided limited survival gains for patients at high cost to Medicare. The study focuses on beneficiaries receiving early access to treatments between 2012 and 2020, with only 45% of these drugs ultimately helping people live longer and the benefit concentrated on just three drugs for melanoma and lung cancer. Additionally, about half of the follow-up studies that pharmaceutical companies are supposed to run after initial approval are never completed. The FDA is urged to better communicate the degree of uncertainty about drugs which have had accelerated approvals so clinicians and patients can make more informed health decisions. The nonprofit Smile Hub recently rated the best states for cancer research based on 13 key metrics, including the number of research charities per capita, cancer mortality rate, and quality of cancer treatment hospitals. Massachusetts, New York, California, Pennsylvania, and Colorado, and a big surprise is there, ranked as the top five states, while Mississippi, Kentucky, Arkansas, Alaska, and West Virginia came in as the bottom five. At the recent Consumer Electronics Show in Las Vegas, Paris-based NAWEX Technologies announced FDA clearance of NAWAX Link, the world's first in-ear EEG system designed for healthcare professionals to monitor brain activity remotely. Customers include pharma companies and contract research organizations looking to improve their clinical studies for anti-epileptic medications and other brain-targeting drugs. Many types of medications are also potentially seizure-causing, so EEG monitoring is viewed as a way to de-risk trials, although the technology has been concerningly underutilized up to now due to the cost, patient discomfort, and logistical challenges with traditional scalp EEG methods.

Deborah Borfitz:

A wireless consumer version of the in-ear technology, known as NowEx Wave, is expected to roll out later this year for non-diagnostic general wellness purposes. The longer term objective is to see an AI-powered EEG app integrated with the earbud devices millions of people already wear every day, ultimately to better understand and manage their neurological health, including conditions such as epilepsy, sleep apnea, and Alzheimer's disease. And finally, researchers at the University of Maryland School of Medicine have completed the first randomized controlled trial to incorporate a smartphone ecological momentary assessment, or EMA, as an outcome measure in a sleep-focused clinical trial and found it can help to determine the effectiveness of sleep medications by detecting improvements in daytime insomnia symptoms like thinking, fatigue, and mood. The EMA approach outperformed traditional recall questionnaires in a clinical trial involving older adults with chronic insomnia taking either a sleep medication or a placebo for 16 nights and using a smartphone app to record their symptoms four times per day throughout the study. Among the subtle and important differences revealed between the two groups is that the drug increased fatigue and lowered alert cognition in the morning, but those effects normalized as the day progressed. As a reminder, links to the articles, studies, and press releases referenced in this month's news section can be found in the show notes. It is now time for today's chat with Proof Pilot's Joseph Kim about the company's playful yet practical core symposium held last September and Boston's legendary Fenway Park. Welcome to the show, Joseph.

Joseph Kim:

Hi Deb. Great to be here.

Deborah Borfitz:

Great to have you. Forgive me, but I must start by asking, did you knock it out of the park, so to speak, with this first and its kind event? I mean, what pharma pros were invited to speak? How many clinical operations folks attended? And it was some real headway made.

Joseph Kim:

Yeah, I, so first of all, we did hit it out of the park. As you know, a lot of conferences kind of look the same. And I think that's a good thing for to some degree because it creates some predictability. But at the same time, they all suffer from some of the same drawbacks, right? There's way too many people, and you're going in a thousand directions. The audiences are so big where people get a little bit shy, kind of trying to speak candidly. And the events are all the same. You're in a hotel, and listen, that has to happen because you're accommodating lots of people. So we wanted to do something slightly different, so we kept it really small. We kept it to about 50 farmer professionals from all sizes. We had folks from Pfizer and Lilly on the big end of things. We had smaller companies like Tris, medium-sized companies like Vertex and Biogen. Yeah, so and and everything in between.

Announcement:

That's pretty good.

Joseph Kim:

Yeah, and we had held it at Fenway Park, which was an amazing venue because A, you get a lot of natural light, and you're 10 steps away from the the stands, so you can get outside and get fresh air instantly. Love it. And we did a lot of fun things there. Like we we put everyone's name on the scoreboard, right? We we did a tour of the stadium afterwards. The the the World Series trophy was there, and so was the mascot. So it was just a really nice, playful, different environment, which allows for sort of fresh thinking.

Deborah Borfitz:

And we're was it just like those 50 companies or and the clinical operations folks from those companies?

Joseph Kim:

Is that we had a couple of other partners, so we didn't want to be too greedy. So we invited folks from Coreo, which is an ERT company, IRT company, and another company partnered with us called Stark Raving, and they're kind of a new on the scene, but made of made of old veterans, patient recruitment company. Yeah, it's pretty good, right? Yeah. So the three of us curated some really good panels, and we we got to brass tacks. I was moderating all the panels, and if you know anything about me, I push people, I do not let them get away with platitudes. In fact, we had a platitude bingo going, and so you know, certain platitudes get said or certain, you know, generic talking points or phrases, and as people win, you know, they get prizes. So in the middle of each panel, you had get someone saying bingo, and then, you know, we stop everything, give them a prize. So it was really, really fun.

Deborah Borfitz:

That is I wish I could have been there. Oh my god. To be clear, the the challenges you were focused on were sort of the problematic threesome: study, execution, recruitment, and engagement. And these are well-recognized, long-standing issues in clinical research where a multitude of strategies and solutions have been tried with varying degrees of success, as I'm sure you know, but the problems seem never to really go away. Do you honestly believe there's an exit from the bottlenecks, at least one that will happen in your lifetime? I mean, make me a believer.

Joseph Kim:

Yes. Okay, right. It's a big if. If we I think let me say it differently, we have lost sight of what we are actually trying to do. We are not, and this might be unpopular, but bear with me.

Deborah Borfitz:

Okay.

Joseph Kim:

We are not here to create delightful experiences for patients. We are not here to make sites' lives easier. We are here to t to rigorously test the safety and efficacy of a drug. And to do that, to give a molecule the best chance at proving that beyond a shadow of a doubt, is to make sure that everybody is doing the protocol in the right way as it intended. So that means the site is doing these things in this order. The patient is doing these things in this order. Now, to the extent we can make that easy for patients in sight, of course, but we're not here to create a spa experience for patients. We are here to test the drug. Okay. So we have to strike that balance between making it palatable, right? Not delightful. Again, we're not creating a spa experience. We're testing a drug. So we got to make it palatable. The science needs to be what it needs to be. And if we focus on the basics and execute the basics with that as our North Star, we can get out of this mess. So let's stop chasing shiny objects. Let's stop flipping the priorities on their heads and focus on making great science happen in a much more effective, uniform, simple way.

Deborah Borfitz:

Makes sense to me. Okay, let's start with holdups and study execution, though. And the crucial determinant really of a clinical trial success or failure and one of the overarching issues that was being tackled at the 2025 core symposium. What bright and novel ideas were unearthed that we can now share with listeners to begin the process of diffusing them across the industry?

Joseph Kim:

Yeah, great question. So I think we have to stop talking about novel ideas and go like again, go back to basics and not lose sight of what we're actually doing here. So for starters, make no mistake about it, clinical research participation and enrollment recruitment is a consumer health experience, just no different from a Botox injection or a dental cleaning or a or a checkup. And why is it a consumer health experience? Because you're actually trying to solicit the man on the street, the woman on the street. We're not SAG actors. These are people, real people with real lives, and we're trying to solicit them to join a study or have a health experience. So, like any consumer experience, how do you get people A to pay attention, B to feel comfortable to quote unquote buy, C, show up, and B, make good on the commitment of what they're trying to do. Now, the good news is this has been figured out because consumer health experiences are often are already out there and the the mechanism of marketing and sales and recruit and buying is well understood. The bad news is it's still really hard to do. And unless we can sort of get out of our own way and think this is something special, quote unquote, the more we'll lean into the the the brass tacks, the nuts and bolts of what actually helps a person feel comfortable to do anything and then let them be successful at it once they've come on board.

Announcement:

Okay.

Joseph Kim:

So I can get into more detail there, but that's sort of the fundamental change we need to really think.

Announcement:

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Deborah Borfitz:

That that's a good foundation. And, in this next question relates to that, I'm sure, because as many listeners will likely know, and you certainly know, recruitment is a massive problem. Clinical trials, probably the single biggest cause of delays and costly failures. And there are a lot of pieces to this puzzle, not just AI and technology, but also data quality, privacy, bias, ensuring human interaction. Yeah, can you name two or three change agents that pharma pros are finding matter the most, old or new?

Joseph Kim:

Here's something that's that's sort of wild. There's a whole there's a whole sort of belly aching about no one knows about research, they don't care about us, they don't trust it yet. And that this is a sort of a back of the napkin measurement. Every year, about two million people finish their role in clinical research. And what do we give these people when they're done? We don't give them anything. No t-shirt, no thank you card. But we should give what we should give them is tell them what mystery drug they took. We should tell them how the study turned out. And if you're really ambitious, we should tell them what their data was.

Deborah Borfitz:

Come on, we're still not doing that.

Joseph Kim:

You're still not doing that. Wow. And finally, like, listen, I try tried and failed at a company myself. So you know it's hard to do. Finally, Transceleria does come out with a a set of principles and content to help their member companies convince themselves that they should do this. Now, there is a company out there that is taking it seriously finally. We've had lots of discussions and people feel like they want to do it, but then it gets to a certain person and they say, Well, what's in it for us? Yet in the same breath, they bellyache that clinical research trust is at an all-time low. Well, listen, if you're gonna keep people in the dark after feeding them a mystery drug, yeah, the trust is gonna stay low. So let's start with what's actually happening. People are rolling off studies every day. So we don't have to wait to see the benefits of this happening in 10 years. They're rolling off every day. At least unblind them, at least give them a lay summary, and then you can start to build trust, awareness, and goodwill. Because Deb, imagine you and I are talking about my participation in research. I imagine at one point you'll say, Hey Joe, well, what were you what were you taking in the end? And if I tell you, like, Deb, I have no idea, that is not gonna, that's not gonna convince you to to improve you know your interest in it.

Deborah Borfitz:

It seems like this would improve like brand allegiance, if you will, simply by communicating with them after the fact and on an ongoing basis. Is that what you're saying? Yeah, that sounded like that's what you were suggesting.

Joseph Kim:

Super low-hanging fruit. We're not breaking any laws, we're not ruining the science. Again, we're just talking about unblinding a patient when they're done and giving them a lay summary, which is really easy to do nowadays with technology. Here's the other thing you're not gonna when that all that stuff is ready, sites have moved on, the IRB has closed the study, contracts are over. So sites aren't gonna lick envelopes and send this stuff out. But there's other you know, capabilities out there. Proof pilot does this as well, where you can safely, responsibly, and at scale, you know, deliver this sort of thing. So that's something like we can do now. That's a really great change agent sort of concept, and there are companies doing that. But more fundamentally, I think we need to really understand patients only come from two places. Either the investigative site knows them or they don't, right? These are two places. If they know them, that is they're a treated patient or they're in a database. Well, the site should have a variety of things they can do to reach out to that patient and help them understand what they're gonna get into, bring them in, make them feel comfortable and enroll.

Deborah Borfitz:

Yeah.

Joseph Kim:

For those patients that they don't know, well, there's a thousand things you can do. You're not gonna do all thousand, right? I'm not gonna put a guy in a gorilla suit on the corner with an arrow saying clinical research this way. I'm probably not gonna do skywriting, but how do most people will learn about things? Well, there's digital media, there's patient communities, there's a finite number of trusted channels you can start to use to generate awareness. Great call to action. But then that middle funnel is where things get really hard. Once they sort of get some interest, there needs to be some way to vet them. And then here's the crucial choke point. No self-respecting study coordinator will let a patient just waltz into visit one without having talked to them first. Full stop. You find me a study coordinator who will let that happen and I'll give you a thousand dollars. And no one's been able to do it. And here's why visit one is a high-intensity visit that costs a lot of money and takes up a lot of time. So it's like calling up, you know, a restaurant and wanting to reserve the banquet space, but then never actually talking to anybody. No, someone was going to want to talk to you and make sure you're a real person. And so a study coordinator always wants to talk to that prospective patient to vet them on a number of levels. And then if it seems like a good fit, then they'll schedule that one, two, three, four-hour visit, which again, the site doesn't get reimbursed for every screening visit. So they have to dole those out very judiciously. And so that little sort of touch point there is one of the main reasons why finding patients that the site doesn't know becomes problematic.

Deborah Borfitz:

Yeah, yeah. Okay. Much to work on.

Joseph Kim:

Yes.

Deborah Borfitz:

As always.

Joseph Kim:

Yes.

Deborah Borfitz:

Finally, I wanted to dig in a bit on the topic of better engaging patients and sites, kind of what you're alluding to here, because there's also a bunch of much discussed reasons why this line of work is so difficult. You know, we're talking here about the travel, the time burdens for participants, you know, sites not being clear on expectations and not, as you mentioned, having the resources they need, perhaps. Study protocols, as you well, well know, are notoriously complex. And all of this creates a sort of perfect storm for burnout from high workloads. In terms of engagement, what are the, again, groundbreaking concepts and or maybe age-old concepts, whatever it might be, revealed or talked about at the core symposium, and/or the hopeful signs that we're you're paving a new way forward somehow by making the most of what's already out there?

Joseph Kim:

Yeah, great question. I think one of the groundbreaking contexts, let's call it, that peep that sponsors have failed to really empathize with for sites is the idea that you know a sponsor thinks about protocol A and they live and breathe that 24-7, right? Most study managers only work on that one study. Now, contrast that with the site. Take the day in the life of a site. At nine o'clock, they're working on visit three for GSK. At 11 o'clock, it's visit five for Pfizer. They have a lunch break, maybe at two o'clock, it's visit 10 for Sanofi, right? Yeah. So their their day looks very different. And when there's nothing more important in research in the moment than making sure that at 11 o'clock, that study coordinator is able to execute visit three for your study. Forget about all the big picture stuff. Like there are people coming in, they need to execute visit three faithfully. Every mistake that happens in visit three on at 11 o'clock on Wednesday has a cascading effect in terms of inefficiency, bad data quality, slowing things down.

Deborah Borfitz:

Yeah.

Joseph Kim:

So, with regard to site engagement, I think people are really understanding like, wow, the study coordinator is the mental switch throughout the day. We need to really think about how to help that coordinator execute that specific visit in front of them with zero guesswork, no detective work, precision, everything at their fingertips. For the patient, it's very different, right? They're going through the lives. Maybe they have a they're on a standard of care. And so they they have a specific behavior, they do the same thing every day. You put them in the research, and that is behavior change all of a sudden, a very high hurdle. Now, the good news is we know how what drives behavior change. It's autonomy, competency, and community. Autonomy is what can you do to help that patient have a little bit more control about when and where some things happen? Now, because this is science, you can't let a lot of variability happen. So I'll come back to that. Competency. How do you support that patient so that they do their part with competence so that they can successfully do what they're being asked to? Now, currently, what most pay what most sponsors do, if they do anything, if they do anything, is give them a bunch of papers and a tote bag and maybe a water bottle that's good luck, right?

Deborah Borfitz:

Like a conference. Yeah.

Joseph Kim:

Yeah. And then you're relying on the study coordinator, and listen, they're not all created equal to give that patient the right amount of guidance and support. But remember that study coordinator is doing 10 different studies. And then so then then there's this community aspect. So it's autonomy, competency, community. How do you help that patient? Not feel like they're the only guinea pig in the in the experiment. Yeah. Because I got to tell you, they don't know that there's five other patients in that site. They don't know that there's 300 more patients in the US or 200 more around the world. They don't know how the study turned out, going back to the data return, right? They don't that so that's a lonely experience. And if you want behavior change to happen, you must tap into all three of those pillars.

Deborah Borfitz:

And that's the place to start. That's how you know how to move forward. And it will look different place to place, I'm sure.

Joseph Kim:

But remember, it's all about consistency too. So this is because this is science, and science is dictated by everyone, does this the same way? So remember, it all has to then be uniformly high quality and sort of uniformly deployed.

Deborah Borfitz:

Yep. Back to the balance point. Good point. Thank you. I understand the core symposium is to be a series of annual events. So what's in store for the 2026 event since we are now in 2026? And how does one get on the invite list, either speak or attend?

Joseph Kim:

Yeah. So this year we're doing some really exciting stuff. I think we might be going back to Fenway Park in the spring.

Deborah Borfitz:

It was hit it out of the ballpark. Why not? Exactly.

Joseph Kim:

Let's do back-to-back championships. It's such a great venue. It's in the heart of a lot of pharma and biotech. It's easy to get to from a lot of other places. Definitely reach out to us at Proof Pilot on LinkedIn or visit our website. There's plenty of ways to get in contact with us. And yeah, if you want to be part of it, then feel free to reach out. We're looking for obviously people in clinical research operations, all on the pharma biotech side of things for the most part, but we'll we'll entertain other folks, maybe in the CRO space, the site space. We're also like to partner with other organizations to co-sponsor this because again, we're not we're trying not to be greedy here and shed the share the wealth here.

Deborah Borfitz:

That the same sorts of topics will be talk talked about. Slightly different.

Joseph Kim:

I don't want to spoil it. Okay. Here's, but I'll give you I'll give you this much. What we're thinking about is there's a lot of debate or just blind spots in terms of the management accounting of research. And what I mean by that is so management accounting is not like is not the the NPV of the drug, right? It's more about hey, how much does it cost to actually build this birdhouse? How much does it cost to build 10 birdhouses, right? That kind of a thing. Yeah. And so the the cost around, well, what does it really cost to enroll one patient? I don't think pharma really knows this, right? What does it really cost to manage 10 deviations, right? I think there was some work with Tufts years ago about the cost of an amendment all in. And this is old data, and I think it was 500K. I bet you it's close to a million now. What's the carrying cost for three extra months of a CRO? Right. So this is the management accounting.

Deborah Borfitz:

I hate to use that word because it may turn people off, but it sounds economic, but yeah, this is an economic issue.

Joseph Kim:

We we are spending money to deliver data sets, right? We should know very intimately what the costs, cost drivers are to deliver those data sets. And frankly, there's I say this with love and respect, there are almost too many scientists involved and not enough sort of management accounting principles being applied. And so we have to get more sophisticated there. And we'd love to start to un unpeel that and help people lock arms on, you know, a things like what does it cost to enroll a patient? Right. I guarantee you, if I ask that to the to the world, we get a million different answers. And that's not right.

Deborah Borfitz:

No, that is interesting. I I really look forward to having this conversation again. We may have to do this every year, really.

Joseph Kim:

I'd love to, yeah. Yeah. And we're gonna do two next year, by the way, one on the East Coast and one on the West Coast. So we don't we want to show love to our West Coast friends.

Deborah Borfitz:

Oh, that was very fair of you. Well, it would be refreshing if even five years from now we were no longer focused on the old tactical problem solving we've been talking about forever, but instead more long-term strategic initiatives, which you seem to be going after, and the integration and optimization of advanced technologies that can help minimize the operational hurdles. Joseph, thank you for all you do to help cast the vision for greater transparency, efficiency, and patient centricity in the research process. And thanks again for agreeing to be on today's show. Really appreciate it.

Joseph Kim:

Of course, Deb, it's been a pleasure talking to you. And yeah, I gotta keep fighting the good fight.

Deborah Borfitz:

Yep, you got it. And as always, a big thank you to everyone out there for listening in. If you're not subscribed to this podcast yet, please consider going to Apple Podcast and doing so right now. So you don't miss your monthly dose of news and perspectives. You'll be hard pressed to find anywhere else. And if you're up for it, I'd also be so very grateful if you'd leave a rating and review while you're there. Help people find us. For more straight talk on studies involving humans, visit clinical research newsonline.com. And if you're a clinical research professional, we hope also to see you at our next Scope Conference, where we make things happen. Bye for now.