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Interviewer: Cancer treatments and medications that are used today, at one point, were clinical trials. And for some, a clinical trial can offer hope that regular cancer treatments can't. We're going to find more about clinical trials now, what exactly they include and maybe how you could get involved in one. Dr. Theresa Werner is the medical director of the Clinical Trials Office at Huntsman Cancer Institute. So clinical trials, when I think of clinical trials, I think of just medications. But it's more than just new medications.

Dr. Werner: Right. Absolutely. Clinical trials are definitely more than medications. Really, they are research questions, so clinical questions about patient's health. And in our perspective here, it's related to oncology. And really, what we're doing is we're looking at multiple questions and trying to figure out the best ways to treat cancer. That's what people typically think of in clinical trials.

But we also do clinical trials to look at prevention. So are there better ways to prevent cancer? We look at clinical trials on how to diagnose and screen for cancer, for example. And we also do clinical trials to maybe help side effects of patients undergoing cancer trials or help them get through some of the other toxicities that they sustain with their regular chemotherapy. So all different aspects of cancer care, we look at with clinical trials.

Interviewer: Yeah, so much more than just the treatments, which I think is what most people tend to think about.

Dr. Werner: Right.

Interviewer: So let's talk about some of the clinical trials that are going on here. How many clinical trials does Huntsman Cancer Institute generally have going on any given time?

Dr. Werner: That's a great question. So here at the HCI, we have over 200 open protocols right now.

Interviewer: Wow, 200.

Dr. Werner: Yeah, in all different phases, all different types of cancer. And we have a lot of . . . probably an additional 100 to 150 trials that are not enrolling patients but we're still following those patients as well. So 300 to 400 protocols that we have available here at Huntsman any one time.

Interviewer: All right. So let's talk about . . . you had mentioned "phases." So explain to me because I've heard sometimes like it's a Phase I study or Phase II study. What does that mean?

Dr. Werner: Right. That's a great question. So there are phases of clinical trials. Usually, they typically start at Phase I and they work their way up to Phase IV, for example. So the trials vary in size and what they're trying to determine. So, for example, a Phase I clinical trial is really the earliest phase or exploration of a clinical question, for example. So some of these trials are looking at medications that humans are taking for the first time, for example, first in human studies. And the objective of a lot of the Phase I trials really are what are the toxicities of these medications? How safe are they in humans, for example, compared to animal studies? What's the optimal dose for patients? So we're really looking at early questions about the drug itself.

And that's sort of historical about Phase I. But I will say, now, most recently, we really are not doing Phase I trials just as blanket trials, like anybody who wants to go on this drug can go on this drug. We're actually being very selective about certain trials. We think with breast cancer, for example, if you have a particular problem in your tumor, you actually might fit this trial better than a person with colon cancer, for example. So we're being a little bit more selective about Phase I's.

Interviewer: And why is that?

Dr. Werner: Well, so the issue is with a lot of these experimental drugs that we study, if you don't target the right patient population, you might not find that the drug actually works for all kinds of cancer. So if you're very selective about what cancers that you actually target with a particular treatment, you will probably get a better . . . what we call a signal or response.

Interviewer: Yes, so there could be a chance that you might have a completely legitimate solution, but just you tested the wrong people.

Dr. Werner: Absolutely.

Interviewer: Wow.

Dr. Werner: Absolutely.

Interviewer: All right.

Dr. Werner: And so we're really . . . even though a lot of people think, "Oh, this is a breast cancer trial." "This is a colon cancer trial," we're actually being really smart about looking at the particular tumors, what's wrong with that cancer. And someone with a particular breast cancer could go on the trial because they have a mutation, as well as a patient with a colon cancer who could go on the same trial and maybe just get as good a response.

Interviewer: Got you. So the Phase I, you also mentioned, it's a lot of times first in human. Is that the most dangerous kind of trial?

Dr. Werner: So it does seem very, very risky. We do look at these drugs very, very closely. We have all the animal studies and so we have predictions of what the toxicities are going to be. But these patients are followed very, very closely on clinical trial. So we usually start at a low dose and we test a certain amount of patients and we look for side effects. And then if those patients do well, we monitor them and then we will slowly increase the dose to get to what we call the maximum tolerated dose. So it does sound scary to a lot of patients, but they are monitored very, very heavily and we're actually looking for all types of side effects in these patients. So it actually is quite safe for the patients.

Interviewer: Yeah. And just even get to Phase I, I imagine there's a lot of regulatory stuff you have to go through as well.

Dr. Werner: Absolutely. Absolutely.

Interviewer: You're just not doing your own thing.

Dr. Werner: Absolutely. And the other thing, here at HCI, we're very experienced in these first in human trials and so, of course, you want to be at a center who has the clinical expertise to monitor and carry out these trials, which our institution is.

Interviewer: Okay. So we talked about Phase I. Is Phase II somewhat similar?

Dr. Werner: It's probably . . . it's definitely more advanced. So really, from the phase I data, sometimes we can get the correct dose, we know the safe dose and so what we're really looking at in Phase II . . . so these are larger studies, maybe 50 to 150, 200 patients in these trials. And what we're really looking at here is efficacy, how well does this drug work for that particular targeted population of that clinical trial? So we already know the safety. We already know the dose, those kinds of things. And what we're really looking for is efficacy.

Interviewer: All right. And what about Phase III?

Dr. Werner: Yeah, so Phase III, these are sort of our larger trials. So now we know that this drug works in said cancer, said mutation, for example, and what we really hope to accomplish in the Phase III trial is comparing the new therapy to what is the standard of care at present. So is it the standard chemotherapy and using a completely different therapy that may work better? Or is it standard therapy versus . . . standard therapy plus the new drug, which could make that therapy work better?

Interviewer: Got you. And then Phase IV? That's a good phase to get to, I have a feeling.

Dr. Werner: Yeah. So Phase IV, we don't do many phase IV studies in oncology because a lot of times in Phase II, if we have the efficacy data, a lot of times, that will be enough. And sometimes we do Phase III. Phase IV are large, thousands of patient trials that, for example, like cardiovascular blood pressure drugs and things like that.

Interviewer: All right. Are these clinical trials or these clinical questions generated within Huntsman Cancer Institute, generally, or is it an idea that is someplace else and then the center is chosen to participate?

Dr. Werner: Yes, so that's a great question. We have both kinds of trials. So, obviously, our priority is looking at clinical questions that are generated here in the community of Utah and especially at Huntsman Cancer Institute. So research that's being done here, for example, in a lab and they want to translate it into humans. So those are what we call "Investigator-initiated trials," and those are really home-grown, written by the physicians and researchers here at Huntsman and carried out sometimes here and also, we'd like to collaborate with Intermountain and we reach out to other cancer facilities that we have great working relationships with.

But also, too, we do a lot of trials that the idea is generated elsewhere and it's a national trial, or international trial, for example. So we do all different kinds of those trials here at Huntsman.

Interviewer: And how long does it take to run through the process from Phase I to Phase IV, or until it even becomes, you know, standard of care?

Dr. Werner: Right. So that is years . . . it can be years to get through that whole regulatory process. But I do find that in recent years, we are getting signals of drugs working earlier than we ever used to. And there are a lot of programs now called "Compassionate Use," where if you see a signal where it works in a particular patient or disease, oftentimes, those will get fast-tracked with the FDA and get approval faster. So I think, you know, people, the community, patient advocates are all sort of realizing that patients need access to these drugs so that we need to speed up this process.

Obviously, we want to do whatever it takes to make sure we have the best dose and we know the safety that we don't put patients at an increased risk and that does take time. But everybody, especially in cancer, time is very important and so we try to expedite things as often as we can.

Interviewer: So why is it that you believe that we're seeing more of these clinical trials that are showing promise much earlier?

Dr. Werner: I think a lot of it has to do with knowledge about patient's tumors. And so, as I said earlier, we don't think of breast cancer as just breast cancer. We know breast cancer, for example, is a very heterogeneous disease and there are lots of different subtypes. So with current advancements in clinical research, we've learned a lot more about a particular tumor. So in a lot of our patients, what we'll do is we'll analyze their specific tumor and really try to find, sometimes, targeted therapy for them. So this is truly the age of personalized or precision medicine.

Interviewer: Yeah, so process in clinical trials is just as important as the thing that we're asking too. It sounds like an institute like Huntsman Cancer Institute is getting really good at that process.

Dr. Werner: Absolutely. So you may know that the Huntsman Cancer Institute just received its designation as a Comprehensive Cancer Institution from the National Cancer Institute, which is the highest designation that you can get. And part of that designation comes from the fact that we are an excellent source, a center for clinical research and clinical trials.

Interviewer: So if a patient's interested in doing a clinical trial, how do you find out about one of the 200?

Dr. Werner: Yeah. That is . . .

Interviewer: Three hundred, yeah.

Dr. Werner: That's a great question. Luckily, in the age of social media, patients have access to the clinical trials literally at their fingertips.

Interviewer: They're pretty savvy, right?

Dr. Werner: Very, very savvy. I'm always impressed. A lot of times, it used to be the doctor bringing up the clinical trial. Now, patients are actually calling, coming to us. "I saw this on your website," or, "A friend of mine wrote this on their blog or Facebook and we want that clinical trial as well." And so, we do have a . . . there's a site on the Huntsman website. It says "Clinical Trials" and it says "Find a clinical trial for me." So basically, you can put in the disease and it will generate a whole list. Some of that doesn't make a lot of sense to, you know, patients. But really, what it is, is to generate dialogue so that when they come to their physician, that they can ask, you know, "What clinical trials are available to me?"

I make it a point in my practice that every new patient that walks through the door, that I think about, "Could they be eligible for a clinical trial?" because sometimes, it's the best therapy available for them. And if you don't think about it and you don't talk to the patient about it, they might miss out on a great opportunity.

Interviewer: When you talk to a patient, if they're a little reluctant to want to do a clinical trial or kind of against it, do you try to lay out the case why it might be an advantage for them, or do you really not force that issue?

Dr. Werner: Right. Well, it's very important in clinical research that the patient is in charge. I mean, we go through the informed consent process very, very carefully with the patients. We talk to them about standard of care and what all their options are. And we do really sit down and talk about risks and benefits to whatever particular clinical trial we're talking about. A lot of times, you know, we let the patients read through the consent forms. We make them take it home and take time to process. They can come back and ask us questions.

We also have patients that are willing to talk to other patients, for example, who have been on a clinical trial. So, someone, a lot of the hesitation is just the unknown and so a lot of times, if they talk to another patient who's been on a clinical trial, they can sort of ask questions that maybe they wouldn't feel comfortable asking their physician but they could ask a patient advocate, for example.

Interviewer: Yeah. So it sounds like it's a decision that is going to take some time for the family and the individual and it's okay for it to take some time and it's going to take some research.

Dr. Werner: Absolutely. There are all kinds. There are patients who come in saying, "I've already researched this and I know that's what I want to do." And there are other patients who are like, "I haven't thought about that and that's great." But we do always want the patient to make the best, informed decision for their care.

Interviewer: Yeah. And of course, at the end of the day, these clinical trials are what really drives all the innovation that can help so many other patients as well. Do some patients . . . are they in it just for that as well? I mean, sure, they want it for themselves. But "Boy, if I could help advance the cause."

Dr. Werner: Right. Absolutely. I mean, every patient we put on a clinical trial, we want them to benefit absolutely. But it really is, there is a higher calling in an altruistic sense that this patient, whether they benefit from the treatment or they get the experimental drug or not in some instances, they're contributing to research. And that's how the standard of care drugs that we have now are people participated in clinical trials and that's why we know what the best drugs are to use. So a lot of people actually feel very gratified knowing that, "It may not help me, but it's going to help somebody else, like my children or my family or future generations," for example. So that's a great thing to see as a physician, you know, a patient who's dealing with cancer is thinking about not just themselves.

Interviewer: If I come in and do a clinical trial . . . I've seen a movie one time, I think, where, you know, the person's like they find out they're in the controlled group, right, which means they didn't get the new cutting edge treatment. Is that the way it works still?

Dr. Werner: Right. That really is a great question and a lot of that is a misconception. So one of the first things that patients come in and say, "Well, I don't want the placebo," which is the sugar pill or the control group as you referred to. So it depends on the trial. So, for example, in the Phase I, the early phase trials that we were talking about where we're looking at safety and sometimes trying to find the right dose, most of those trials, almost all of them, they don't have placebos. You're pretty much guaranteed to get the study drug and so we inform patients of that right up front.

Usually, we don't get into the placebo or the control arm until we get into the further phase trials. But the thing about clinical trials that I want to express to the public is that, you know, we would never deprive someone of a therapy that we thought was important to them. So if there's a great chemotherapy drug that's on the market that they really need to have for the cancer, that might be the right answer for that patient and not doing a clinical trial. But oftentimes, the clinical trials are . . . they're new drugs, they're used in concert with the chemotherapy so that might be a better option for patients.

Interviewer: Yeah, to control side effects or something like that, yeah.

Dr. Werner: Right. You know, I just encourage patients to ask their physicians but we do really a good job of bringing clinical trials forward to patients. But oftentimes, in a new diagnosis visit where you're talking about their new diagnosis of cancer and you're outlining all of the, you know, the pathology, you're going through their lab work, it gets to be overwhelming for patients and sometimes the clinical trials get put at the very end. And so, I just ask patients to make sure they ask about those things if their physician doesn't get to that portion because there are, sometimes, great therapies that may be missed if they don't take part in a trial.

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