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Episode #13 - Clinical Trials Part 3

Steve:

Hello, everybody. And welcome back to episode 13 of CCA's Medical Minute Podcast. I'm here again with Tim Schroeder, chairman, founder, and CEO of ... I'm just going to go ahead and say CTI. I'm not going to.


Tim Schroeder:

Perfect.


Steve:

I'm starting to get tired. So, this is just a fantastic company here in town that does clinical trial research on an outsourced basis, and we talked about that in our first episode. And so I think we'll cover a little bit of just some separate things here to close things out, at least for now.


Steve:

So, Tim, I've referred before about... This is, at least in my view, that there's a little bit of a new paradigm for clinical trials. It may not be that the infrastructure or the approach has changed. It may just be my own perception of it. But I think back to a time when probably the second scariest thing you ever heard after you've got cancer was you should probably consider going into a clinical trial. And so, I think people to this day probably still associate that with, "Oh my God, I'm out of options." And so I think to your earlier point, there are so many trials going on, and so much of it is on the forefront that it doesn't necessarily mean that anymore. Is that a fair assessment?


Tim Schroeder:

I would say very much so, Steve. If you look at it, one of the things that we tell people frequently today, especially ones with advanced malignancies, ones with poor prognosis, whether it be ovarian, whether it be pancreatic, whether it be liver, whether it be a glioblastoma, something like that is the new treatment approaches are moving so quickly. What we tell people is if you can buy six months or 12 months, the game change may be significant in that period of time. And to your point, ten years ago, I would not have said that to somebody because it would've been really falsely leading them and giving them a sense of something that wasn't real. But today, I can tell you just CTI, and we play a very, very small role in a big, big industry, but for instance, we've launched four glioblastoma trials in the last six to eight months.


Tim Schroeder:

Now, I don't know who's going to develop the therapy that ultimately ends up being a breakthrough there. That's very much an unmet need, unfortunately, right now. The current treatments, I would say, are successful in only a very, very small percentage, and the recurrence rates are extremely high, but I have to say, that's a field where if you said to me, "What do you think GBM treatment looks like five years from now?" I'd say I have no idea other than it says it will be very different from today, and it'll be much more successful than it is.


Steve:

Yeah. Yeah, no, that's a really great perspective. And I was hoping that you would kind of hit on that because I kind of see that in my own little world with prostate too. And I think back to... in fact, I mean, a lot of the drugs I've taken weren't even available ten years ago. And so maybe one becomes less effective, you roll off of one and onto the other, and then you get a period of time, a little bit of a holiday where things are going pretty well, but I kind of view it the same way. It's like, you get a little bit of extra time, and I don't mean like the extra time that you're only going to get a little of extra time. You get some more time for the next thing to come along.


Steve:

And so, I think that is a new paradigm in a way that people should probably start to think about cancer as well. So I'm an eight-year cancer survivor, and I've benefited from a clinical trial I went through last year, but I think there's no consistency or maybe consistency and understanding. Sometimes people will say, "Oh, if you're going to a clinical trial, it's free." And is that true? I mean, is it sometimes, or are the insurance companies bulled? Or is there ever a time you pay to participate in a clinical trial? Anything like that?


Tim Schroeder:

No. That's an important point that you raise. I would answer it in a couple of ways. Steve, the first thing I would say is I would depend exclusively on my primary caregivers to say, is there something in a trial that you think might benefit me over the standard of care that's out there. And keep in mind we tend to think of trials always involving experimental or investigational drugs. Sometimes trials are looking at already approved drugs, but looking that at them in a different combination of drugs that might be approved for one type of cancer that has not been fully approved yet for another type of cancer.


Tim Schroeder:

But an answer to your question, when I think of it, if somebody approaches me, I'm seeing my oncologist, and he or she approaches me and says, "Hey, there may be a trial for you." I think that that opens up the conversation. Okay. Why do you think this may be beneficial to me? What would be the approach, downside, timeframe, and obviously, you bring up the issue of cost? One of the things would be who is the sponsor of the study. So in some cases, the sponsor of the study, most of the time when we think of it, is a pharmaceutical or a biotechnology company. But you could also have investigator-sponsored studies in which case it might be the institution, the university of whoever. It might be the physician's practice that's sponsoring the study. It might be actually the physician themselves sponsoring the study. But in all of those cases, the one thing I would say is no one should pay anything above what they typically would pay.


Tim Schroeder:

In typically pharmaceutical sponsored studies or biotechnology sponsored studies, everything about your care is usually provided at no cost. That's not always the case in an academic or university-sponsored study. In those cases, sometimes everything over and above is covered, but the standard is still billed to your insurance company. As a simple message to your listeners, I would say yes. You should incur no additional cost. And in many cases, you should have all costs removed by participating in the study. But it's a great question and do not be afraid to have that conversation with whoever's talking to you about the research.


Steve:

Gotcha. Okay. That's good to know. And so, here's one thing I kind of learned last year. I said that I had participated in a clinical trial and I didn't know this because when the conversation first came up with my doctor, it was like, I thought, "Well, I'm going to be, it might be as an inpatient. What is it?" It turned out that I don't want to say it was nothing more than, but it turned out it was basically a PET scan with a new type of radioactive isotope that was in use in Europe but not yet approved here.


Steve:

So I drove to Michigan and I had a PET scan and it took about two hours and I drove home. And so sometimes, I think when people might hear, "I have to go into a clinical trial." I mean, a lot of these can be outpatient or things like that. Maybe even imaging tests or things like that. It doesn't necessarily mean that you're going to be in an inpatient setting for weeks at a time.


Tim Schroeder:

No. That's right. In fact, most are not in an inpatient setting. The vast majority are not. But to your point with those regulations that we talked about in an earlier episode when the FDA got involved with this over the last several decades, there has to be consent given or permission given to participate in a study. So something as simple as drawing some of your blood, or even using blood that was drawn for another purpose, if it's going to be included in a study, you have to give consent. So you're absolutely right. It's every time we come up with a new diagnostic test, a new image approach like you participated in. Any of those things have to require consent to participate in the study, and they're reviewed the same way through an institutional review board. They're also reviewed by the FDA.


Tim Schroeder:

So, in a lot of ways, there are different levels of complexity in different research. And what I'll hear from many people say, and this was particularly common. I think during the last two years, when it came to COVID research, people said, "I'm not participating, looking for a benefit for myself; I'm trying to help society." And I think we've seen that in my years when I was at the University of Cincinnati and Cincinnati Children's as a faculty member, I was a transplant immunologist. And I could tell you, the first heart transplant, the first liver transplant, the first kidney transplant. All of those people participated in a study to see if the procedure itself actually could be beneficial to them.


Tim Schroeder:

And then all the therapies associated with preventing rejection, things like that. So they're all of these are incremental steps. And even the smallest one for somebody to say, "I can give my time and participate," just like you did in an imaging thing. Who knows? That may now become the gold standard for imaging, and the only way they were able to ascertain that was by having a hundred people or a thousand people like you participate and compare it to what we had before.


Steve:

Yeah, no, that's good. Great point. So the last question for this episode is... the right answer is not to call Tim Schroeder. But the clinicaltrials.gov. So when you think about people trying to understand and navigate their way. God help you. But if you're trying to really understand all the clinical trials that are available, is there any resource that is kind of easier to navigate than clinicaltrials.gov? Or should you really rely on your provider to do that for you, or are you on your own on this?


Tim Schroeder:

Well, you raise an interesting point. There is a government website where every study has to be registered. And in fact, if we're managing the study as CTI on behalf of Pfizer or whoever that biotech company is, we actually update that sometimes weekly, with new information, but that's all out there. The difficulty is the world we work in has a lot of abbreviations, a lot of slang terminologies, and acronyms that make it very hard for everyone to understand. So I think to your point, and one of the things that I'm so impressed about with the Cincinnati Cancer Advisors is if you have an advocate, it could be a family member. It could be your caregiver, or it could be a third party like CCA. But I think those are the groups. Don't stop asking questions. Don't try to... You always want to educate yourself, but it can be overwhelming both worrying about your own condition and then trying to understand the world of research around it.


Tim Schroeder:

Whatever you do, don't give up. There are people. And I would say, you'd be surprised how many of those people there are that are willing to give you their time and their thoughts on these things and refer you. But clinicaltrials.gov is not a bad place to go. Because you could put something in very complicated or very simple like you could put breast cancer in and you would be surprised to find that there might be 10,000 active studies in breast cancer.


Tim Schroeder:

Now you could put something in like triple-negative breast cancer and find out there are less than 500 studies. So if that applies to you, now we've narrowed it down quite a bit. And you can also sort according to the location, so you can go in there and say, "I live in greater Cincinnati, and I really don't want to go more than 300 to 500 miles." You can sort it that way. You can sort by phase. So if you say, "Look, I'm really interested in a later phase study rather than an early phase." There are all different ways to do that. But to your point, it can be very onerous going through there with some of the languages.


Steve:

And here's a little bonus question. I mean, does your oncologist generally have a really good working knowledge of all that that's going on, or is the patient in just as good a shape, position to figure out what might be available to him?


Tim Schroeder:

I think, Steve, you can get into a little trouble with generalities because if you take an oncologist that's at an academic medical center participating in cutting-edge research, he or she probably has a different view than somebody who's in a community setting. It's not right or wrong, but it's just a different view on what's there. So in some ways, I think I would always say, "I want the patient to be an advocate for themself." And I would say in my experience where we have the luxury where we work with more than 2,000 hospitals clinics around the globe, the vast, vast majority; I'd say 99.9% are always open to saying, "I don't have that answer to your question, but I know somebody who is." Or, "I can't offer that study, but I know somebody who is offering it." So I think it behooves us just to continue with the message of ask, ask, ask, and continue to do your homework.


Steve:

Okay. All right. Yeah. It's always good advice.


Steve:

Well, that is... We'll wrap this episode up. We've been very privileged to have you here today, Tim. And now that I know that you've got an office that's only like a 20-minute walk away, maybe we'll have you here more often if you're willing to join us.


Tim Schroeder:

Absolutely.


Steve:

You've been a great guest, and it's a really, really important topic. And there's so much that's going on out there that represents the kind of the next wave in care and treatment and breakthroughs and potential cures. So it's something we need to be talking about more, I think.


Steve:

So I really appreciate having you here today, and good luck in your travels in January. I think you hit the ground running what, right around the first of the year?


Tim Schroeder:

I'm hoping so. We've had a few already canceled.


Steve:

Oh really?


Tim Schroeder:

We'll see. But yeah.


Steve:

All right.


Tim Schroeder:

Thank you for having me, and most importantly, thanks for what you guys are doing here at CCA.


Steve:

Thanks so much, Tim. I really appreciate it. All right. Everybody take care, and we'll see you next week.

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