Radiopharmaceutical Clinical Trials: The Myths, The Facts, and the Impact

In this episode, we're joined by Dan Rogers, Vice President of Clinical Trials at BAMF Health, for an inside look at the world of clinical trials and their critical role in advancing cancer care.

Clinical trials are often misunderstood. Are patients treated like guinea pigs? What happens if you receive a placebo? How do clinical trials actually lead to new therapies becoming available to patients? And why are more cancer patients considering clinical trials earlier in their treatment journey?

Dan breaks down the clinical trial process—from Phase I first-in-human studies through FDA approval—and explains why BAMF Health has become a national leader in radiopharmaceutical clinical research. The team also discusses BAMF’s growing RadioNexus network, investigator-initiated studies, pediatric research opportunities, and the unique infrastructure required to bring innovative therapies to patients faster.

Chapters

00:00 Introduction to Clinical Trials
 00:26 How Dan Rogers Entered Clinical Research
 02:21 Clinical Trials 101: What Are They?
 04:33 Why Clinical Trials Matter for Patients
 05:40 How BAMF Health Accesses Leading Clinical Trials
 08:19 Expanding Access Through RadioNexus
 10:12 The Infrastructure Behind Radiopharmaceutical Trials
 11:53 Shaping Clinical Trial Design & Innovation
 13:26 Why Being First-in-Human Matters
 14:45 Who Participates in Clinical Trials?
 17:13 How Patients Find Clinical Trials
 18:01 Why Clinical Trials Are Becoming Earlier Treatment Options
 20:46 The Challenge of Finding the Right Trial
 22:49 Investigator-Initiated Trials at BAMF Health
 26:05 Pediatric Theranostics & the Future of Research
 27:31 Clinical Trial Myths & Misconceptions
 28:00 Myth: “I’m Just a Guinea Pig”
 29:21 Myth: “I Might Get a Placebo Instead of Treatment”
 30:39 Myth: “Once I Join, I Can’t Leave”
 31:14 Myth: “Clinical Trials Take Too Much Time”
 32:45 Imaging Trials vs. Therapy Trials
 33:48 The Future Impact of Clinical Research

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Christine VanTimmeren

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Transcript

Christine VanTimmeren 0:05

Welcome to another episode of the BAMF Health Podcast. Today we are focusing on clinical trials. Clinical trials a huge part of what BAMF Health does and what we're about. And so joining us today, our special guest is Bamf Health's VP of Clinical Trials, Dan Rogers. Dan, thanks for joining us.

Dan Rogers 0:23

So nice to be here. Thanks very much for having me.

Christine VanTimmeren 0:25

Appreciate you coming and talking about what is sort of a core of Bamf Health and what we do and what we're focused on. But let's back up a second. Clinical trials research is a super unique field, really interesting thing to get into. So I want to know is this something you always wanted to do, something you sort of fell into? How does one get into clinical trials and research?

Dan Rogers 0:49

I think uh you'd find if you talk to anyone in this field that people don't grow up uh with an image in their mind of, man, if I could only be in the clinical research field, uh I will have made it. Yeah. Um I I actually, my parents were in the medical field and uh going into college, I was trying to buck that. And I was looking at uh teaching and other opportunities and kind of exploring like uh some people do early in their college careers. And my first job ended up being working in the ER uh with my dad, who uh was a physician there. And really what I learned from that is being there with people kind of on their worst days of of their lives and being able to support them and help them through that, that was really meaningful and um it really shapes uh my my career starting out from that. And so uh I was exposed to some research opportunities early on and helping out some of the ER physicians in that and um understanding, you know, what it takes to move medicine forward and and not being satisfied with the the status quo of how things are working today. Uh and I was really excited about that. And I took my first job out of college in clinical research.

Christine VanTimmeren 2:00

And you stuck with it.

Dan Rogers 2:02

And I stuck with it. It was it's uh it's been evolving over time in the ways that uh that I help out in in the field and the ways that I partner with uh physicians and scientists uh at Van Andel Institute at at BAMF now. Uh and it's been it's really been a joy my entire career.

Christine VanTimmeren 2:20

That's great.

Dr. Brandon Mancini 2:21

That's awesome. And I think just for those listeners that may not be familiar with clinical trials, or maybe they've heard the phrase, but not exactly kind of kind of dip dove dived into uh it when it's all said and done. What's your clinical trials 101? Kind of what are they? What is the purpose they serve? How would you explain that uh to people with a variety of different backgrounds?

Dan Rogers 2:43

Sure. Uh so really every medicine, every imaging procedure, every you know, uh technique that uh that's used in medicine, it has all come from uh doing research to understand would this work and help patients out better than what we're doing today. Clinical trials are a way to do that very rigorously uh in a way that um is is controlled, is safe, and then looks to understand, yeah, is this better than what we have with with other opportunities? So that's probably the easiest way that I describe clinical trials one-on-one. Um it, you know, today, particularly in oncology where we do a lot of trials, this starts early on in a phase one trial where we're giving that drug to humans for the first time, or that uh that new treatment technique, that new imaging. And uh really a lot of work has happened in in the laboratory uh and and bolstering is this going to be safe for humans? And once it passes mustard there and it is approved by the FDA, then we do the first phase one trial there. Sure. That's done in a limited number of patients. They're really looking to just see is this safe? And uh what dose should we be looking at for an expanded population in phase two? And and then trying to understand in the next phase, you know, is this working uh in those patients? Is it efficacious, is what they say. And then that's gonna move on to a phase three trial where they're gonna compare that against the existing standard of care or existing treatment that they're using today. If all that works, if it proves out better than that, that's what leads to uh, you know, a submission of the US to the FDA to get seek approval from the FDA to be able to sell that drug commercially and make that available widely to um to patients across the US.

Dr. Brandon Mancini 4:32

Yeah. No, and we're lucky in Grand Rapids, not only our institution, but others just have all the different phases of trials and all the different opportunities for cancer and beyond. So it's always awesome. And to your point, right, every single thing that we ever take or might have heard of in the medical field has gone through this process. And I think sometimes people are concerned about a clinical trial for various reasons, which we'll get into in a little bit as well. But it's really something that a lot view as an opportunity or a unique offering uh to advance the science to help themselves and to uh continue to kind of advance the medical field uh as a whole. So it's really great.

Dan Rogers 5:10

Yeah, totally agree. We're very fortunate in Grand Rapids, you know, with the medical mile, with the hospital systems that we have in the area, with the independent oncology practices and and other groups here, there's really a focus on having these innovative options available for our patients. And not just a last line of when everything else has failed. More and more of these are being seen as you know, upfront and earlier opportunities to catch that disease when that treatment might be more effective for them.

Dr. Brandon Mancini 5:38

Right. Absolutely.

Christine VanTimmeren 5:39

And here in Grand Rapids at BAMF, we really are on par with institutions across the country who are doing the most advanced clinical trials. We have access to some of the most advanced and and the newest and the most novel. Um so how do we get access like that? And how unique is it to have access like that?

Dan Rogers 6:07

Well, I think our our portfolio of the trials that we have here and largely on in the oncology space for for patients is really a unique thing. Um this this stems from the vision of Anthony Chang, our CEO, and the mission that he set out from the beginning is that we're here to increase access and increase affordability of this precision medicine for patients. He saw the promise in this technology and wanted to help further the field. He saw a gap that a lot of academic medical centers and hospital systems didn't have the infrastructure, both physically and the people, to be able to carry out trials like this and efficiently do the clinical development. Um, when you're you're developing a new drug, you're racing the clock on its patent life. And that's what's driving the investment from a pharma company to actually develop that drug further and for that to be available to a lot of people. And I think what we've done very well at BAMF Health is helped to be one, the infrastructure for this of the novel technology, like a total body PET CT that we have and uh the SPECT CT that we have for looking at images after the treatments given. As well as we have the team and people to be able to conduct these trials who are really experienced in doing complex radiopharmaceutical clinical trials. Uh, and so that's the niche that that we've built and where we've uh developed a lot of expertise so that a lot of the industry looks to us to be the first site to open up these trials, to give those first drugs to those patients. We have the the space that's safe and and set up. We have expert physicians who know if patients would qualify and do well uh participating in that trial. And and so uh really we have brought a lot of these pieces together here in Grand Rapids. Um very unique in a small town to be able to do that as an independent center. Um we're up there against uh a lot of the top centers in the US that uh that you would know well, you know, academic medical centers or large hospital systems that have really robust clinical trial programs.

Christine VanTimmeren 8:18

That's great. And it's not only here, it isn't about just what's happening in West Michigan and what's happening in Grand Rapids, but you and your team are building a network of sites across the country. It's called Radio Nexus, is that that platform or program. Um so tell us about that and the drive to get these trials not only here in Grand Rapids, but then enable sites across the country.

Dan Rogers 8:48

Yeah, I'm it you know, at BAMF, it's never been about just Grand Rapids. It's been about how do we increase access availability, affordability, you know, everywhere. And and we knew that Grand Rapids was just the starting point. We knew that if we could prove this out in Grand Rapids, that we'd be able to move this much more broadly. I think what's really exciting is the success that we've had in Grand Rapids has led to some really um tremendous partnerships with Henry Ford, with University of Kansas and Children Mercy Hospital, and a number of uh health systems that we're gonna be excited about announcing uh in the near term. Uh I think what's resonating with them is we've developed the program for this, particularly in clinical trials, to support um doing these trials efficiently and safely and you know, just a strong, robust program for that, where they've had challenges doing that themselves. And we're there to work together to further develop a program in their hometowns and make this available there as well. I think what really becomes powerful is when we have a network of clinical trial sites that are able to do the same trial or you know, groups of trials, we can really move the field forward that much faster, make these treatments and diagnostics available that much sooner. Uh, you know, advancing precision medicine. I'm really excited about the development of our network.

Christine VanTimmeren 10:11

Yeah.

Dr. Brandon Mancini 10:12

And I think this is super unique because their gnostics are radiopharmaceutical treatments, right? The infrastructure, as Anthony and and then you have uh elucidated, is kind of the principal um rate limiting step when it's all said and done. Maybe the inexperience in that space, the concerns over handling radioactive material, how do you incorporate this? Who's gonna be uh the leader in that space in a given academic or uh community practice? Um, in trying to put all these pieces together, it's a little bit less straightforward with radiation medicines when compared to other treatments, right? It's imaging, it's urine and blood monitoring, it's lots of hours, lots of radiation safety and handling on the front and back end. So I think it just speaks volumes to what you've set up, what BAMF has set up, to uh the ability to do what we've done in Grand Rapids as kind of that showcase or that flagship and that exemplary opportunity that we can share with others. Um, it just adds so much value when it's all said and done. And um, I think because of everything that's happening in Grand Rapids, it will then accelerate things throughout the country, which is super exciting. So

Dan Rogers 11:25

I think um beyond just the partnerships in our network that are that we're building, I know that we're having an impact on the field and we're seeing, you know, people looking to us, talking with us about, you know, how do we build a facility like yours, how do we build a team like that, and or modeling after what we've done. And that's the biggest form of of flattery. And more importantly, that's having a big impact on the patients that they're serving as well. So I'd love to see that uh across the field.

Dr. Brandon Mancini 11:52

Yeah, and it's also neat just kind of because we've been involved for so many years now, where it feels like we're getting involved earlier on, even in clinical trial design, or at least the opportunity to give feedback when it's early on and there's not many sites, or we may be the first site included. And so that's also great because we've seen how things have worked here in the United States and we know what some of the do's and don'ts don'ts are, some of the things that might preclude the ability to get people enrolled or help more patients more quickly. Um, and I think from my perspective, it's been really neat to have more of the openness or more of the trust or more of the voice within that space to make sure that patients are getting what they need and that institutions can actually carry these things out as well. So

Dan Rogers 12:34

I wholeheartedly agree with that. I think the gap between sponsors, you know, these pharma companies and and a site like ours can be a really wide gap. Often there's a company in the middle called a contract research organization who's really skilled at running clinical trials. Unfortunately, across the field, there's just not a lot of depth in the radio pharmaceutical niche that that we focus on. And because we have so much experience on trials here, we've done about 40 trials at our center since opening in October of 2022, which is again, I put that up there with with any other center across the US. Uh, I think our depth of experience there has really led to that ability to shape the design of trials and for the betterment of not only the data that comes out of that and understanding did it work or not, but also the patients that's serving as part of the trials. Yeah.

Christine VanTimmeren 13:26

Because of that expertise, then we're getting opportunities to dose the first patient in the US, dose the first patient in the world. And maybe for the general public, they don't understand the significance of that. So talk to me about what is the significance of being the first in the world to sort of initiate and launch a particular trial.

Dan Rogers 13:50

I think it's uh one a big honor to have that and hold that responsibility and be the experts like Dr. Mancini and Dr. Kulkarni at BAMF to to be the lead investigators that are on the front edge of that. You're you're really trusted with, hey, you've done this before and and we know that you can um not only manage this project well, but also take care of the patients well on on the trial. And then I I think again, us trying to move the the ball forward faster for developing these these what we think these these drugs have a lot of promise for um helping more patients. We want to be pushing that as fast as possible, as safely as possible. And by being that leading site, by starting up the trial sooner, by getting that first patient dose sooner, we're just one step closer and faster than than we were as an industry before. Yeah.

Christine VanTimmeren 14:44

So let's talk about that patient population. I think in some cases, patients are coming to us because this is sort of a last option. Maybe they've run out of standard care options. In other cases, people are saying, I understand the value of clinical trials, I understand the science, and I want to be part of it, and I just want to help advance the science. Then you've got healthy individuals in some cases who want to sort of volunteer as well from uh the opposite perspective. So tell us about the variety of patients that can participate in trials like these.

Dan Rogers 15:20

Yeah, I think all that you mentioned are really important to us again, moving the our understanding of these new drugs or new imaging forward, this new care forward. Um, from our clinic, I know that we really take the approach of trying to make patients aware of all the opportunities up front uh that are available to them. And uh, I would love to see that for every patient, particularly in in the oncology space. And that's really difficult to do, to convey all the opportunities. And, you know, these are complex trials that have a lot of different um upsides and you know, potential risks that come along with that, and you need to consider that carefully. And and having uh a physician that can talk through that with you is really meaningful. I and I'm really uh proud of the way that that Dr. Mancini practices within our clinic. Um, and I know that that same approach is used quite a bit here from uh from other providers at in the independent oncology groups or the hospital systems close by too. Um, but also keeping Dr. Mancini uh apprised of all the opportunities is is really difficult too. We can probably talk more about that. But in terms of patients that that come in, yeah, I think um some are independently reaching out to us, you know, finding us through our website or clinicaltrials.gov or uh other ways, you know, maybe their physician knows that BAMF might have opportunities here and they're referring them for uh uh for a consult and consideration for some of the trials. Um and I do think some patients are more aggressive and and trying to understand their opportunities sooner and and do that themselves. Um, we've also seen an uptick of um patient-facing services that might be you know web, you know, like uh uh what would be the right word for this? Uh

Dr. Brandon Mancini 17:12

Search engines or

Dan Rogers 17:13

Search engines, guide tools, but or even times that you know they include nurse navigators or PhDs involved that can understand the science and help to translate that for someone who didn't study that but has the disease or their family member does, and they want to consider what trial options are out there. So having a someone that can help you navigate that and understand the opportunities is I think that's something that's really valuable for the community at large. Um the healthy patients, I think is really interesting. We often see that from caregivers or loved ones of someone going through that. Hey, is there anything that I can be doing further to participate in this? Um so I think that probably covers the waterfront on how people find out about trials or you know, or are given the opportunity to consider participating.

Dr. Brandon Mancini 18:01

Yeah, and even like in the national guidelines, which kind of is that blueprint for making sure patients are getting the highest level of care, there are several situations that if patients have had disease that spread outside of the area it originated from. So for example, prostate cancer, if it was found in the bone or elsewhere, a lot of times it'll list clinical trials like the first recommendation or at least one of the options that should be offered at every different uh decision point that the patient and their provider would have to make. And I think it just speaks on behalf of the volume and the promise within clinical trials that is happening, but also the science is just advancing very, very rapidly. And so just always keeping it at top of mind that these things should be considered and have a lot of uh potential is super important. And even in my daily interactions, I mean, when patients we go through all the options, we ensure any clinical trial they may fit for and or standard of care therapy with the risks and benefits of either approach. But there is a ton of interest in that space because some patients even find that if it's a clinical trial that might be a good fit, that they see it as a way of maybe even saving standard of care options for later if they're on a trial that is effective in improving their situation. And so sometimes the next great thing is in that trial. Um, and people have to take an informed and calculated opportunity to consider things like that, um, which may end up really helping themselves and others for years to come. So

Christine VanTimmeren 19:31

And that's an important conversation. Maybe that conversation isn't happening everywhere, but that's something, like you said, you see every day. You get to talk to a patient and say, yeah, maybe you could come here and get our standard care treatment right now, but let me offer something different. I mean, that's you have to know your stuff, you have to know the patient, and you have to know how to have that conversation.

Dr. Brandon Mancini 19:54

Yeah. No, it's definitely the art of the process. And some people are there and some people aren't. And we meet people where they are, and it's more of just knowing. Um, to Dan's point, there's a ton of proactivity happening as well, meaning patients may know that clinical trials are in their future as far as options that may or may not exist. And they're trying to gather as much information as they can, knowing what exists or what the prospects would be, not only at our institution, but across the country and world. Um and so there's a lot more proactivity in that space, finding what the options are, when it fits, what needs to be done to be considered, uh, and so forth. Um, and as information, as AI and things continue to evolve, um, we're in this information seeking and information available era where people want this and um are getting set up for success and living their best lives even with their cancer. So

Christine VanTimmeren 20:46

Kind of brings us to the discussion of how do you find clinical trials? And I think the quick answer probably is it's often tough, especially if you're a person with no medical background, you've never had a family member go through something like this before, you've never thought about it. Um it is tough. Like you said, there are more sites popping up that are offering resources and maybe a more person-friendly searchability structure, but it it's still hard.

Dan Rogers 21:18

Yeah, you know, just as I was saying, I it's it it's a real challenge to put all the pieces together. I think even if you find uh you know a trial at the site, whether you're looking at clinical trials.gov or one of these other search engines that you come across, or maybe the website of the the practice or health system that you your care is is being done at, just because you find that listed there, it doesn't mean that one, you're the right fit for that trial, or or two, that there's it it's open for you to be able to participate in that. Particularly in early phase trials. Um it it's gated uh so that they um treat a couple patients and then they look to see safety wise how did that work. Work for those patients, you know, do we need to make any adjustments to we continue forward? And so that, you know, available limited slots, your timing really becomes an important thing. So having a good advocate and your provider and helping to understand what the opportunity is and what the timing constraints are with that, I think are really uh important with that. In our niche of radio pharmaceuticals, in addition to the slots, we have challenges uh on the logistics front of when those trials are available too. Like maybe uh doses of that drug are not available because it's made across the world and it's limited on how many doses they can make. And so it's just this extra layer of um logistical challenges with our type of trials.

Christine VanTimmeren 22:48

And we're not only doing pharma trials, which that's the majority of what we're doing, pharmaceutical company sponsored trials and we're a site for those, but we do our own. We look for opportunities for us to lead the research and and come up with the trial for something in particular. So tell us about our investigator-initiated trials that BAMF does.

Dan Rogers 23:13

Yeah, I think maybe just as a high-level concept, what we tried to set up from an infrastructure was the ability that whoever has a question about um would this treatment work or would this new uh way of taking care of patients be better? We want them to be able to come to us and for us to be able to take that the rest of the way for them. And so whether that's a pharma company that has a new agent or a new um uh device, or if that's you know, our own physician scientists or some of our partners that that that come along, um, we want to be able to execute that study and help the patients and get the data from that to understand did that work or not, you know, in as efficient, uh safe, and high quality a process as possible. And so out of our own science, uh I think it wouldn't surprise you that we're trying to again advance precision medicine and and understand um how this technology might work better for patients. Uh things like how do we use a lower dose of CT and understand if that's as good as existing uh CT technology, or can we use a lower dose of the PET tracer that we use? Um, how can we um utilize this technology the best that we can for understanding the disease or um you know furthering the care of those patients, um expanding into new disease populations where we see that, hey, this imaging works in cancer, we have a suspicion that it might work in another field. Um, and so applying it there and studying that in those patients, I think, is the type of work that we do at BAMF.

Dr. Brandon Mancini 24:52

Yeah, and I think that allows for unique questions to be asked or proof of principle, proof of concept type ideas, where maybe if you can enroll 10 to 30 patients, for example, of a certain imaging technique, that may then open the conversation if there's any signal that something is working or you're detecting something or something seems safer better than standard, that might be enough to then allow for uh the propagation of a much larger trial that could involve many sites across the country or world. So a lot of times the ability to be nimble, to ask unique questions. Um, they even have something called N of One trials, where if you have something super unique that really applies to a patient and you need to move quickly and tie uh try to address something for them, that you can have a protocol that addresses uh a unique image or uh therapy in that person as well. So there's a lot of different ways, but I think just the speed, the unique questions, um it just allows a little bit more flexibility at the institutional level. Um, but then again, because of those relationships, because of that experience, then ultimately may spark a lot more ideas or bigger, broader trials in the future. So

Christine VanTimmeren 26:04

I think part of the reason we're very excited about the partnership in Kansas City, especially involving Children's Mercy, is that potential to also investigate this field of medicine for children. It's something that hasn't been done a lot. And that's got to be exciting for you and your team to think about not only what we can do from the adult perspective, but the potential that exists, the possibility that exists for this in children.

Dan Rogers 26:35

No doubt. I mean, uh, you know, pediatrics have long been um maybe shied away from in the development of new um new treatments, new imaging, all that, because of some inherent risk or perceived risk of doing research involving children. It's at the end of the day, it's much more complex work to figure out how to do this safely and and move forward in that way. And so having a great partner like like CMH or you know in Grand Rapids at Helen DeVos Children's Hospital and partnerships there, it's really meaningful to um stand side by side and and work towards you know advancing this field in that space. Um obviously oncology is the area that uh we'll dive into initially, but I think there's a lot of opportunity outside of that using radio pharmaceuticals or precision medicine for imaging and therapy uh in the pediatric populations. Yeah.

Christine VanTimmeren 27:30

It's exciting. Okay. We have time for some rapid fire questions, or maybe not so rapid fire. We'll give you a couple minutes to answer. Um, but when it comes to clinical trials in general, people have fears, they have misconceptions, there are myths about what they are and what they aren't. So let's address some of those. The first one is sort of this idea that you're a test subject, you're a guinea pig, you're just being tested upon. And that's not how it works.

Dan Rogers 27:59

Yeah, wholeheartedly agree. Um, you know, before any medicine, any new treatment goes into humans, it has to be approved by um ethics committees or what's called an an IRB, as well as the FDA if it involves a new um, you know, medicine or or device. And the rigor in that is is quite extensive. And so making sure that it the type of trial that's gonna be done involving uh a human, it's been so vetted out by the time it gets uh to patients. So in terms of like, oh, you're just gonna be injected with a new drug and we'll see if that works or not, is completely a farce. Um it's a very well-controlled thing, and they're studying to understand is the safe first, first and foremost, and then second, um, does this work or not?

Dr. Brandon Mancini 28:52

Yeah, it's almost like even more strict sometimes than standard of cares, right? You're monitored closely, there's a lot more checkpoints, et cetera. So if anything, it's even closer and more personal and more contact with the healthcare team. Yeah.

Dan Rogers 29:06 Dr. Brandon Mancini 29:11 Dr. Brandon Mancini 29:11

It can be a real upside for patients. You know, more personalized care, actually participating in a trial is actually gonna give you a lot of that, you know, healthcare facing time. Right.

Christine VanTimmeren 29:20

The other thing is that, and there's some nuance in in this, but the fear that I'm going to get a placebo and I'm not going to get the actual treatment um unfounded in on in some cases.

Dan Rogers 29:33

In some cases, yeah. I mean, when you're in that later phase, phase three of trials where we've already in phase one understood that it's safe, and phase two, it's safe, and we're seeing that okay, this could work well. Phase three, they're really looking at is this better than what we have existing or not. For cancer patients, it would not be okay to give a cancer patient a placebo where we know that that disease is there and it needs treatment. And so you're getting uh randomized to in some cases to either the the study drug, what we're we're trying to test, what's new, or what the existing standard of care is. That's very common in the oncology space. Now, outside of oncology and maybe cardiology, maybe diabetes, uh other settings, um, it might be different. And it really it's about what first and foremost is safe and ethical for that patient. And it has to be if they need treatment, it has to be the standard of care. Uh maybe you don't need treatment though, and maybe that's where a placebo might make sense in that type of trial. But that's the way that people designing trials have to think about and have to meet the rigor of.

Christine VanTimmeren 30:39

Al right. Other people might feel like, okay, I go down the path of um enrolling in a clinical trial, and once you're in, you can't stop. You're stuck. That is also not true.

Dan Rogers 30:50

Correct. Yeah. Consent uh for uh participating in human subjects research is ongoing and you have to give that uh and you can withdraw at any any time, any point in that. There are some rules if you're receiving a new therapy. Sometimes that has to be considered and worked out with your physician physician. How do you come off of that therapy safely? But uh you can withdraw your consent at any point in time.

Christine VanTimmeren 31:14

And then finally, the time commitment. Um, people might be concerned, oh, I'm gonna have to be in the clinic every single day, and I'm gonna be there for eight hours a day. And it in some cases is multiple visits. Um, but it could also be one single visit. So it's not necessarily weeks on end of coming into a clinic.

Dan Rogers 31:36

Yeah. I mean, each trial has its own nuances of you know, what the commitment looks like for participating in that. What I'd say our team does really well is looking for opportunities for this to fit into your life. Um, you know, often in the oncology space, uh I think uh, you know, your cancer can become your life. And and it's really important for us that we find a way that that treatment works and that participation, that trial works for you, for you to be able to return to as much of your life as possible. Yeah.

Dr. Brandon Mancini 32:05

And I would say on average, just uh for the radio pharmaceutical trials that we have, um after the first treatment, there might be a little bit more visits for three, four days, but just on average over a period of months, it's about once every other week that something might have to be done, just as a complete broad uh statement. Um so to Dan's point, it's there's more than normal, but uh definitely a balance between uh coming to the clinic and not and and knowing that they're set up to try to optimize the the science and the the information gathering, but the well-being of the person um as far as time commitment is always thought of as well.

Christine VanTimmeren 32:44

Well, and there's a really quickly, there's a difference between the commitment in a therapy trial and the commitment in an imaging trial, maybe. What's the distinction there?

Dan Rogers 32:55

Imaging trials where we're trying to understand does this targeted PET tracer go to where we think it's gonna go? Does it uh image uh uh the disease and not the rest of your body well? Um, those can be really short. It could be a one visit, as short as one visit. Just literally come in, have your imaging done, and go on your way. Um sometimes it's multiple time points, multiple uh scans that are that are being done as part of that. It can just vary trial to trial. Therapy trial, different, right? Uh typically you're gonna have multiple cycles of a trial, you know, roughly a month or six weeks apart. Uh, and with the first one, as Brandon mentioned, uh, you're gonna have more safety uh follow-up close to that that first treatment. And then the subsequent cycles are gonna be more about, you know, get the therapy and we'll follow up, you know, in a week's time or two weeks' time.

Christine VanTimmeren 33:48

Yeah. Regardless of what the trial is, incredible opportunity to advance science, bring more options to to people, to patients, um, and give hope to people in the future that will catch disease quicker and be able to treat it more effectively. So thank you for what you and your team are doing. We appreciate it.

Dan Rogers 34:10

Oh, thanks very much for having me here today. Yeah. It's been a pleasure.

Christine VanTimmeren 34:14

Thanks for joining. Al right, we'll see you next time.