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Treatment Talk | What You Need To Know About Clinical Trials As A Treatment Option For Bladder Cancer

With Dr. Peter H. O’Donnell, Dr. Neal Shore, and Patient Advocates: Kevin Williamson and Bob Wrenn

Year: 2021

You can read the full transcript of Treatment Talk | What you need to know about clinical trials as a treatment option for bladder cancer at the bottom of the page.

Part 1: Do I have to go to an academic hospital to be on clinical trials?

Video (13 min) | Transcript (PDF)

Part 2: Will I be a “guinea pig” for a new treatment or will I end up with a “sugar pill”?

Video (5 min) | Transcript (PDF)

Part 3: What is the cost of being on clinical trial? Will I have to pay for everything? Will all the clinical trial be “free”?

Video (8 min) | Transcript (PDF)

Part 4: What happens after I sign the consent forms to be on a clinical trial?

Video (13 min) | Transcript (PDF)

Part 5: Are there clinical trials for my particular diagnosis?

Video (3 min) | Transcript (PDF)

Part 6: What are some of the key questions I should ask my doctor about clinical trials?

Video (7 min) | Transcript (PDF)

Part 7: Health Equity and Clinical Trials

Video (4 min) | Transcript (PDF)

Full Transcript

Stephanie Chisolm:

This is a Treatment Talk program from the Bladder Cancer Advocacy Network and tonight’s topic is “What You Really Need to Know About Clinical Trials as a Treatment Option for Bladder Cancer.”   I’d like to welcome Dr. Peter O’Donnell from the University of Chicago and Dr. Neil Shore from down in South Carolina. We have two patients with us today, Bob Wrenn and Kevin Williamson. I’m just going to start by welcoming you all for being here with us. I wanted to talk a little bit about clinical trials as a treatment option because a lot of people don’t always think about this. The difference with Treatment Talks, these different types of webinars that we have, is that we’re bringing in the patient voice into the conversation. We wanted to make this a little bit comfortable for both patients and the doctors to talk about these things. When we did a little bit of planning we thought it would be really helpful to do a little bit of myth busting because I think that there are a lot of myths about clinical trials. What I thought I would start to do is give everybody a chance, on the panel, to address the issue about, “I have to go to a big research hospital to be involved in a clinical trial.“

Stephanie Chisolm:

Dr. O’Donnell, I’m going to ask you a quick question to get us started. You’re in a large academic institution at the University of Chicago and you do many clinical trials, right?

Dr. O’Donnell:

Correct.

Stephanie Chisolm:

Is that the only place in Chicago that people can get into a clinical trial?

Dr. O’Donnell:

I’m sure it’s not. Sometimes patients have that myth that clinical trials are only happening at the big academic centers. While it might be true that academic centers have maybe access to more clinical trials on average, one of the big pushes is actually to get these clinical trials out into the community so that all can have access. I think that certainly over the past decade or so we’ve done a good job of that in bladder cancer and Dr. Shore might be able to speak to that as well.

Stephanie Chisolm:

Dr. Shore, you’re there in Myrtle Beach, South Carolina, in a large urology practice, and you do clinical trials in your practice. I think because that makes it a little bit more convenient, you’re in the community. Just making it easier for people to get involved in the clinical trial so that they don’t necessarily have to drive a long distance, because you’re kind of a long distance from some major cities in South Carolina. For people who live on the shore that might be hard for them to get to. Why do you do clinical trials in your practice and do all urologists or medical oncologists do clinical trials in the community?

Dr. Shore:

There’s a lot of things there that I think are really important. I’m really looking forward to hearing both Kevin and Bob talk about their initial impressions when a physician would say to them, “Hey, we’ve got a clinical trial,” what was their initial reaction. The bottom line is, I’ve been in community practice now since 1990 and I’ve done over 400 clinical trials.

Dr. Shore:

I’m really proud of the work that we’ve done at Carolina Urologic Research Center. I started the facility in the ’90s. I have 18 full-time employees. It’s all we do with clinical trials. Prostate cancer, at least in the world of urologic oncology, was getting all the attention the last 15 years and in the last five or six years bladder cancer’s really come into its own. In fact Stephanie, and I think Peter would agree, we have more trials than we can find the right patients. We have this sort of embarrassment of riches. We have so many great trials. Why are trials important and why do I do it? It’s the same reason why anybody does research. It’s because we have unmet needs. At our core, whether you’re a community practitioner or you’re a researcher in academia we’re all physician scientists and when we have patients who are still dying of advanced cancer or we need better diagnostics to identify early stage bladder cancer or better markers to understand who’s going to respond or not, this is what makes precision based therapy and makes us all better.

Dr. Shore:

I know I think I speak for Peter and everyone at BCAN, we are 100% committed to bladder cancer research because that’s the only way we, number one, up our excellence in the approved therapies. The approved therapies by FDA, CMS, and commercial payers, but more importantly it’s always about trying to find new diagnostic tests, new biomarkers whether it’s blood based or urine based and new therapies so that we don’t have patients succumbing to bladder cancer. Those are all the reasons. The answer is, is that we’re getting more community based sites involved both medical oncology and urology. I think combining the excellence and the expertise of BCAN, the AUA, the SUO, ASCO, LUGPA we’re all really working together now to say we all need to be doing clinical studies. In fact, being a clinical study option is in the guidelines for all of the leading organizations throughout the US and the world. Being involved in a clinical trial is a standard of care, frankly. I think this is a very, very important message.

Stephanie Chisolm:

It is and I’m really glad that you’re here and have an opportunity to share that message. I know that some people are a little bit anxious about being in a clinical trial. Kevin, why did you participate in a clinical trial?

Patient Advocate Kevin W.:

Well, it was the third thing that I did after chemotherapy and a targeted therapy. We were definitely looking for answers and happened to be in the right place at the right time. This is eight years ago. I don’t think the trials were quite as plentiful back then. We were with Dr. O’Donnell. He had access to the trials and made them available to us, talked about it, asked questions. At my stage, for me, it kind of felt like, I’m not sure it was, but it kind of felt like it was my last chance. I had tried other things that were available prior.

Stephanie Chisolm:

Okay. So why did you do a clinical trial? You’re not in a big city. Kevin is closer to Chicago.

Patient Advocate Bob W.:

Why did I do a clinical trial? Well, quite frankly, Dr. Shore said to me, “You have bladder cancer,” and then he said, “But I got this program I want to put you in… A test program.” And he says, “But I’m going to take care of you.” So I said, “Well, you know what? Let me think about that.” And about five minutes later I said, “Well, you know, I’m 80…” At the time I was 87 or 86. I said, “You know, maybe God put me here to do this clinical trial and maybe it will help somebody else.” That’s kind of where I came from because it seemed to me I had to have some kind of treatment so I might as well do this clinical trial while I’m doing it.

Stephanie Chisolm:

That’s a good reason to do that. So, Dr. Shore, tell me about that in terms of is there an age limit for clinical trials?

Dr. Shore:

I would just say that my friend Mr. Bob Wrenn who just gave you an answer, he’s 87 going on 47. He is a prolific exerciser and he’s a proud graduate of Virginia Tech, which is a beautiful university. I would encourage everybody to go and take a look at that. It’s all about performance status. Meaning, how is a patient living their lives? I don’t think there is any limit on an age. Of course we have some men and women who have a lot of health issues and they’re frail and they’re even, arguably, in their 40s and 50s. Maybe they’re severely obese and have bad poorly controlled diabetes. Maybe they’ve had vascular problems. Maybe they’ve even had an amputation, in their 40s. And then you’ve got a lot of men and women, like my friend Bob here, who is extremely active. I do not hold back on patients because of a chronologic age. It really comes down to how fit they are, their performance status and very importantly their desire to keep going.

The will to make it to another milestone of life. A child’s graduate, a wedding, a trip once COVID simmers down. My answer, Stephanie, is unabashedly I don’t let age get in the way. That’s just a number.

Stephanie Chisolm:

Dr. O’Donnell, when we’re looking at clinical trials isn’t it important to test a treatment option in the actual population that will be using it? Isn’t that also why it would be important to ensure that older people are a part of a clinical trial?

Dr. O’Donnell:

Of course. A lot of people wonder about that and they want to say that doctors want to be able to use the results of the trial to generalize to other patients, but even beyond that I want to remind folks, and I know Dr. Shore believes this too, we’re doing these clinical trials to help the patient that’s sitting in front of us, right? When Mr. Williamson came to me he’s the one that needed the treatment and I actually believed that the clinical trial was the best option for him to help his situation. Not to try to generate some research down the future. Yes, we hope to generate new treatments for thousands of patients to come, but really the doctors first obligation is to try to find the best option for that patient there. I’ll address maybe one of the things that you’ve shown on the slide here Stephanie and a lot of patients feel that, and Kevin even said it. He felt like in his case it was the last option for his situation. At that time there weren’t a lot of options but we have a lot of clinical trials now that are trying to compare newer options to the existing standard of care. It could be the frontline therapy. This could be the first line treatment that you’re going to receive for your cancer and we’re trying to still improve upon that to cure an additional percentage of patients. It’s not as if clinical trials are only when you feel like you’re out of options. You might be actually appropriate for a clinical trial much earlier in the course of your disease and it does not mean that you’re getting a sugar pill. It doesn’t mean we’re trying to experiment something on you. It might actually just be a way to get a treatment earlier than might be available to the general population.

The FDA, the government, have a requirement that doctors test these therapies often in all settings of the disease. You can use an approved drug and then just use that in a different earlier setting of the disease and that still has to be tested.

Stephanie Chisolm:

In most clinical trials they’re going to give you either the new treatment option or they’re going to give you standard of care when it comes to clinical trials that are being used in the cancer space. Those clinical trials are not necessarily testing outrageous or unapproved treatments, right? Can you, as the doctors, talk a little bit about that? I think that’s one of the things that also makes patients a little nervous. They’re afraid they’re going to get a sugar pill and they don’t want to be a guinea pig and not get anything. That’s not the case when it comes to cancer clinical trials. Then they’re afraid that you’re going to try some crazy thing on them and it’s not an approved thing, or it’s not a logical thing. You’re just doing an experiment. How do you all come up with these clinical trial ideas?

Dr. Shore:

When I talk to patients about clinical research, first of all I explain that whether it’s an actual therapy, whether it’s an oral therapy or something that’s given intravenously. Or maybe it’s just a blood draw or urine based test to look at a new predictive marker that could help us better diagnose bladder cancer or a response to a treatment, and it might even be, eventually, we look at different kind of imaging tests. Newer scans that might be more beneficial. I tell patients first and foremost that this is a decision that they’ll have time to review. We send them home with a consent form. By law the consent form cannot be higher than an eighth grade education. It’s written purposefully, not to dumb it down, but so that it’s not filled with a lot of confusing medical language. I always encourage the patients to take it home and review it with their partners, their family members, their friends, and then come back and let’s talk about it.

Dr. Shore:

If they choose to do a study, which is going to help potentially, potentially, themselves, as well as advance healthcare, not just in the US but arguably throughout the world, they only stay involved in the study as long as the study is helping them. The moment we see that they’re not getting benefit from it we move to something else. I usually like to say, “You’re not signing a 30 year mortgage. You’re giving your consent to be involved and the moment you don’t like what’s going on we’ll move to something else.” I find that, that’s remarkably reassuring and I hate the word guinea pig but everybody brings that up. “I don’t want to be a guinea pig.” This is how we cure cancer. This is how we cure heart disease.

Dr. Shore:

Fortunately our patient advocates who are on the call today, Bob and Kevin, they get it and we need more folks like that to understand this is how we help all of our fellow friends and colleagues who have bladder cancer and other cancers.

Dr. O’Donnell:

Stephanie,you asked where do these therapies come from, right? A lot of times these therapies that we are testing in clinical trials have been studied in other clinical trials before. They go through different phases of clinical trials and so often times it’s that these trials are in the last stage of development, meaning they’re in the final clinical trials that the government needs before approval, but we actually have a lot of experience with these drugs in earlier clinical trials so patients shouldn’t feel that they’re the first ones where these therapies are being tested. In most cases that’s not the case. We actually already have a lot of prior experience about how these drugs work and the side effects, the potential side effects of these drugs, which I think really makes it much more palatable to patients.

Stephanie Chisolm:

Some patients are doing the early, what they call, phase one clinical trials. You can look on the BCAN.org website for information about what all these different phases mean, and those are the really early trials. They’re much smaller groups of people where they’re just testing the concept. Then most patients are going to be involved in a phase two or phase three clinical trial where they’re really trying to see, “How does this happen and how does it work in the general population?” Again, as you just said, they’ve tested it out so they’re not using crazy, outrageous stuff. Dr. Shore, you talked about… I think saying that eloquently, like a mortgage. You’re not committing to it forever. If it doesn’t work we find something else. I think that’s really great.

Stephanie Chisolm:

Another myth that we have with clinical trials is that all costs are covered and I don’t even have to provide my insurance information. But that’s not always the case, right? Sometimes you have to give your insurance information to cover some of the costs and are all insurers covering the costs of being on a clinical trial? Do you know this information Dr. Shore and Dr. O’Donnell? You probably have a team of people that help patients understand it better, but what’s the general consensus behind that?

Dr. Shore:

Well, I think this is an extremely important point. Sometimes all costs actually are completely covered, but not always. One of the things, depending upon where you are, healthcare in the United States is very expensive. These approved agents that Peter and I and BCAN have been involved with, once they get approved by the FDA and they come to market they’re not inexpensive and they cost a lot of money. If you’re a Medicare patient and you don’t have good secondary insurance or you’re a commercial patient and you have a high copay or a high deductible or if you don’t have insurance, you’re a hard working person and you just never got insurance, the cost of healthcare can be astronomical.

Dr. Shore:

Where I practice in the coast of South Carolina, it’s not as affluent as other parts of the country. When I’m able to get a patient into a study where all or a significant amount of their healthcare is covered and, by the way, doing that you’re even saving the healthcare system because these are typically covered by grants and/or private industry sponsors so we’re kind of doing some benefit to the healthcare system. Most importantly, to me, is I see so many patients who just get really, have the economic toxicity of trying to pay for their healthcare. This is where a research study, a clinical trial, is a bit of a godsend, frankly.

Stephanie Chisolm:

Excellent. These are great. Kevin and Bob, you didn’t have any issues with helping in terms of being part of the clinical trial where you had to have a huge cash outlay or anything like that? Things were generally covered and you had people that you could speak to on the clinical trial team to help out with any questions about covering those costs, right?

Patient Advocate Bob W.:

Absolutely.

Patient Advocate Kevin W.:

Yes.

Patient Advocate Bob W.:

From that standpoint mine cost didn’t cost me anything. I have a good supplemental insurance through my Medicare so I am in good shape financially as far as medical costs are concerned and I have been really fortunate to have Dr. Shore. I had some real good support nurses who have worked with me, outstanding people. I am so fortunate to be around that group. And like you said, I feel like, hey, I’m going to live another day. Yeah.

Stephanie Chisolm:

A lot of drugs that are being used now in bladder cancer are really targeting specific nuances within somebody’s tumor genome, in their genetic profile, so a lot of these trials are requiring genetic testing. Not too long ago patients had to cover the cost of having genetic testing. It wasn’t necessarily always offered in a doctor’s office. Is that something that’s being covered more and is it often times covered in a clinical trial to find out if you’re the right person to be testing a particular drug that’s targeting a mutation? Is that something that’s generally covered in the cost of doing a clinical trial?

Dr. O’Donnell:

I’ll speak up here. I know I saw Kevin was trying to say something there as well, so maybe we’ll give him a chance next. Regarding costs, I tell my patients, “The costs of doing a clinical trial should be nothing additional to what you would pay for getting regular standard of care,” and that’s actually required in the consent. Anything that would be billed normally to your insurance, like the doctors’ visits, the regular labs, regular CAT scans that might be done during the course of a clinical trial, those things that are considered part of care that you would be doing, even if you weren’t in the trial, will be billed to your insurance. Anything additional that the study is requiring the study would pay for, including the cost of the experimental drugs, including the cost of a genetic test if it’s required in order to get into that trial. That’s the general rule of thumb about how these costs work.

Dr. O’Donnell:

Kevin, you and I talked a little bit about that when you were thinking about your trials initially. Do you want to comment?

Patient Advocate Kevin W.:

Yeah, I mean, that was eight years ago and at the time you were heavily suggesting that I get it because it would help me figure out what treatment, really available, not just trials, but treatments that were available for me. At the time I think it was $5,000 or $6,000 and we went ahead and did it. I think we were, as you had told me later, we were kind of on the cusp of this kind of changing winds and I never got billed from the genetic testing company. Somebody paid for it and I’m assuming it was the trial, the drug company. I’m not sure. My cancer was progressing so quickly at the time that I got the surgery and saw you that I’m not sure if we didn’t get the genetic test that we would have picked the right thing quickly enough. I’m a big fan of genetic testing and any time anyone comes to me that has cancer that’s the first thing I ask them, “Have you been genetically tested so you know what you’re dealing with. Is your doctor suggesting that? I think that’s a good idea. Talk to him or her about it.”

Stephanie Chisolm:

That’s one of the most exciting things about the whole field of bladder cancer is it’s becoming very personal and this genetic testing is being examined on so many different levels. As we mentioned earlier, it’s an embarrassment of riches. We have lots of clinical trials and patients don’t always get involved in them because they don’t see that there’s an opportunity for them to use that as a treatment option. I do encourage people to talk to their doctors about the clinical trials.

Stephanie Chisolm:

Let’s switch gears a little bit and talk a little bit about what happens once you sign that consent form. There are certain inclusion and exclusion criteria that you need to meet. Why is it so challenging to be accepted into a clinical trial? Dr. O’Donnell, can you mention that a little bit? I know they have criteria that you have to meet to be included, but then if you have some other quirky criteria you can be excluded because you have, maybe, another health condition. Why is it such a tight window for what you need to have to get into a clinical trial?

Dr. O’Donnell:

Right, this is a good topic. I’ll explain what happens. When you have that initial conversation with the doctor about your interest in a clinical trial, a lot of times by the end of that conversation the patient is really excited that they’re going to hopefully do this trial, that they’re going to get access to one of these really exciting new drugs ahead of the general population. So you have that discussion and you sign a consent form, and as Dr. Shore said, this is not a contract that you’re signing. It’s consent. It means that you understand the risks and the potential benefits of doing that study. Once you sign that it really starts what we call a screening process. In my office a screening process can take usually around two weeks or less. What happens during that screening process is you’re going to go through a battery of tests that are screening procedures or screening tests, to make sure that you’re actually eligible to qualify for the study.

Dr. O’Donnell:

It can feel a little bit frustrating during that time because you’re waiting, right? Your cancer probably was just progressing and you’re waiting to get into that clinical trial and now you’re being forced to go through all these tests. These tests are required to make sure that it’s safe for you to do the trial. They also form as a baseline so that we know exactly what your cancer looks like, what are your lab work as you enter that trial? So that we can know if anything changes once you start on that treatment. It’s really important to do those baseline procedures and if those baseline procedures come back as qualifying you. Actually, some panels will go through and check off the boxes to make sure you sort of have parameters from each of these test results to make sure you meet the safety criteria for going into the trial, then they will allow you to go into the trial. It’s not really your doctor that gets to decide that, you don’t get to decide that, it’s an independent set of rules that you have to meet, That process can take about that two week time that I talked about. That’s the screening. Patients can feel really uncertain during that time, but it’s a joyous day, really, when we’re able to call the patient and say, “All your tests came back, you qualify for the study and now you’re going to start.”

Dr. Shore:

You’re good to go.

Stephanie Chisolm:

I think you talked earlier, Dr. Shore, about the consent form and it means an awful lot of paperwork. There’s somebody in the office. There’s somebody in your practice or in a large institution that can help with all of that paperwork. It’s not something that should be really daunting – but there is paperwork, obviously, in being involved in all of that. When it comes to asking questions do you ever have a problem if people ask questions about what they want to know about being in a clinical trial, Dr. Shore?

Dr. Shore:

No. I kind of have two rules of thumb. A physician who says, “Look, you’re asking me too many questions I’m not going to answer,” or, “You’re asking for a second opinion and I’m not going to recommend one for you,” it’s time for you to get another physician.

Dr. O’Donnell:

Yes.

Patient Advocate Bob W.:

Amen.

Dr. Shore:

It’s super important for patients and their families to have a full throated discussion about all their treatment options, approved therapies, or within research. I just want to amplify a point that Peter made, the rigor of being involved in a clinical trial is oftentimes much more detailed and costs are not even brought into the consideration that then what you would get by commercial payer standards and, oftentimes, even Medicare. There’s incredible rigor and thoughtfulness that goes into these clinical trials. Real exceptional attention to detail.

Dr. Shore:

Now, I will say, in all honesty, it’s not an abundance of paperwork on behalf of the patients or what we typically call. If you’re in a clinical trial you’re a subject. The sites have to do all the paperwork and I’ll be honest and say this paperwork is onerous but it’s not on the part of the patient. We have to do it and we have to dot the ‘i’s and cross the Ts because there’s incredible scrutiny by all sorts of monitoring agencies, including the FDA. We have to really be on our game. Sites that do this, community, academic, it’s a passion and there’s a lot of dedication to it. Patients get state of the art monitoring and care. Sometimes, even though the patients are not having to do a lot of paperwork, they do have to come in for some, oftentimes, for some additional visits so there are some patients who just say, “You know what? It’s just not for me. I’m fatigued by having to make too many visits,” or maybe, “It’s too hard for me to get there.”

Dr. Shore:

We try our best to work within patients calendars of their lives and sometimes if there’s a cost consideration for travel we try to help out with that, with patient approved stipends. I just want to be completely clear about that. Paperwork isn’t the burdensome issue of the patients, it’s for us who do the actual studies and all of our personnel.

Stephanie Chisolm:

Right. You bring up a really good point, Dr. Shore. Let me ask Kevin and Bob, did you feel, at any point that, “Wow, I’m just so tired of going into that office. I don’t want to go in today,” and yet you have to because you’re scheduled within the trial for another test or another procedure, something along those lines? Was that at all a challenge to you or did you find ways around it by talking to the people that are on the trial team? Kevin, do you want to start? Were there any issues you had?

Patient Advocate Kevin W.:

I mean, at first it’s different, right? When you get cancer you’re not used to going to the doctor a long time. When you have cancer you go to the doctor all the time. There’s a shift, for sure. I never really felt it was all that onerous. You can schedule these things out, usually, fairly well in advance. Up front, when you’re trying to get into the trial, yeah a lot of that you just got to kind of jump when they say jump. But you’re the only one who benefits or doesn’t benefit when you jump, whether you jump or don’t jump. It’s a pretty personal decision and when it comes down to your life I think you just kind of try to make that work.

Patient Advocate Kevin W.:

I was fortunate enough to not have transportation issues or things like that. I can understate how those would be a problem for people. I thought that the University of Chicago did a great job of helping me schedule everything out and really doing everything for me. All I really had to do was show up.

Stephanie Chisolm:

Bob, did you have any thoughts on how much time it took for you to be in a trial?

Patient Advocate Bob W.:

Yeah, as far as the busy schedule’s concerned, my schedule is not very busy anyway. The doctor’s office is one of the places that I go most anyway, not just to Dr. Shore’s office but he happens to be on 82nd Avenue here and 82nd Avenue is full of doctor’s offices. I think I have a home in each place there. But anyway, I haven’t seen any difference in being in the trial or not being in the trial from a stand point of time involved in treatment and so forth. Like my friend said, you got cancer, you make your schedule around it and that’s pretty much what you do. But no, I haven’t had any real hardships about that.

Stephanie Chisolm:

Well, because we’re talking about this as a topic, there are lots of big academic institutions, big hospitals, that are doing big clinical trials, but Dr. O’Donnell if you had a patient who lived in the outskirts, a little too far to come in on a regular basis, and then Dr. Shore you’re there in a more rural… Not rural, but beach-like community, and it’s not so much of a big, large, urban, academic center. How do you work together, let’s say, to have somebody participate in a trial that might be happening at a large academic center but maybe do some of their routine care in a local doctor’s practice? Does that happen often, Dr. Shore? Do you know if there are other doctors that are doing that?

Dr. Shore:

One of the things that I’ve noticed in the arch of my career is the collegiately and the breakdown of the ‘town and gown’ phenomenon. The tertiary academic centers, whether they’re medical oncologists or urologists, are now working so much better with the community based physicians because let’s face it 85% of cancer care happens in the community. We have so many amazing clinical studies. Well, you just want to get patients enrolled so that’s how we find out our data and we come up with an answer. Is it working or not? Being collegial, being communicative with the leading academic centers of excellence is absolutely key to community practice, and working together if patients decide to move. Many patients will say, “Hey, you know what? I’m getting on in years, I want to go and move back to where my children are in Pittsburgh,” or North Dakota or somewhere and so we reach out. BCAN is a great resource for getting people connected. Whether they’re moving from Florida to Los Angeles, et cetera.

The collegiality, I have to say, has really improved dramatically. At the end of the day, it is our pioneering academic researchers who are leading the way in new, early phase studies but ultimately when we want to get volume of patients involved in research we have to work well with the community centers, too.

Stephanie Chisolm:

Dr. O’Donnell, do you have opportunity to do that on a regular basis? Where somebody comes in periodically to your practice, maybe into the city, but then they get their regular care and maybe their routine examinations out in a local community in Illinois. Does that happen?

Dr. O’Donnell:

Certainly. The trial does have rules that only sites that have the trial open can actually conduct the procedures related with the trial and administer those treatments. However, a lot of the academic sites nowadays have satellite facilities, right? Satellite clinics that are open out in those more non-urban centers. I think the whole idea of that is to make sure that we have access to everyone or as many people as we can for these trials. That’s really important. I do have a lot of my patients that say, “It’s tough to fight traffic and drive into the city and worry about parking,” and so forth. A lot of times our patients will come for an initial second opinion, we’ll find that a clinical trial might be the best option for them, and we’ll go ahead and get them enrolled in the trial, but they can actually do a lot of the procedures at one of our satellite clinics that’s much closer to their home.

Then they might come back and see me every few months, say when they have a scan or a reevaluation, and I can sort of weigh in on the case to make sure we’re on track and the patient really likes keeping that continuity with their doctor at the academic center but could get those things done close to home. We’ve really made a lot of strides in that recently, I’d say.

Stephanie Chisolm:

This is a great conversation. I think there’s a lot of really good information you have been sharing, it’s wonderful. Let’s talk a little bit about clinical trials across the spectrum of disease. Non-muscle invasive all the way through to advanced disease. It seems to make more sense for patients with advanced disease but there are clinical trials that are being done right now to help determine things like how to better detect bladder cancer and how to treat non-muscle invasive bladder cancer. Can you talk a little bit about some of these options? Dr. O’Donnell you are a medical oncologist so you’re more likely involved in the clinical trials that are applying to people with advanced disease. But Dr. Shore, do you see that there are a lot of trials that are being conducted now that are being done with patients with non-muscle invasive disease?

Dr. Shore:

Oh, unbelievably so. Right now I was just looking at my sheet. Right now I have 20 different bladder cancer studies of which I have… Let’s see. One, two, three, four… I have about eight or nine in non-muscle invasive bladder cancer, varying stages and about nine or 10 in muscle invasive and metastatic disease.

It really is exceptional and Peter and I have lived through this. Five six years ago the number of studies in bladder cancer was really paltry and now it’s just exploded. All for the better of our patients in early stage disease, non-muscle invasive, all the way to metastatic. It’s incredible how much progress has been made in the last five or six years. Sometimes people will say we have more trials than we have patients now and that’s an incredible problem to have. It’s great for patients and it’s great for science. It’s great for the multi-disciplinary approach to improving healthcare.

Stephanie Chisolm:

Sure. You know, I just have to say that BCAN was started in 2005 because there was nothing going on in research in the bladder cancer space. When Diane and John Quale had been dealing with the disease for five years that John was diagnosed, they were just so frustrated that nothing was being done and now it’s really gratifying to see that there are options. And remember that you can find clinical trials that are there in your communities, in your state, by visiting BCAN.org and clicking the clinical trials tab under the research tab and you’ll be able to find a clinical trial that’s there in your neighborhood for your diagnosis. So they do cut across the disease spectrum.

Stephanie Chisolm:

I do see that there are some questions coming in so I wanted to keep moving through my slides and then we’ll open it up for questions.

Stephanie Chisolm:

The next question I had, really, were there any particular things that you, Kevin or Bob, really kind of put through your own mental test about, “Well, why should I do this clinical trial?” Or are there any common questions that you, as researchers, get that you think, “Patients should ask these questions. These are good questions?” We’ll start with the patients first. Kevin, was there anything that was going on in your mind that you think, “Well, I wish I had asked this question before I got involved in the trial?”

Patient Advocate Kevin W.:

I can’t recall anything like that. I’m fairly inquisitive and if you’ve met my wife you’d understand that she’s very inquisitive. Dr. O’Donnell’s smiling. One of the things that I would counsel everyone here, when I got diagnosed with cancer my mental faculties were weighed on pretty heavily, and I think when you’re entering something like this and making this kind of decision it’s very important to have someone with you who’s not sick, who you trust, who knows you, who knows what’s important to you, who knows what questions to answer and just let them go. I was a little bit of an observer for a lot of this until I got my mental faculties back. But I think my wife did an excellent job of asking all the questions so we could understand what it was.

Patient Advocate Kevin W.:

Did we understand what it was when we started it? No. We didn’t go to medical school for 16 years or whatever. But if you have a conversation with your doctor you ask questions, and like Dr. Shore said, if they won’t answer your questions find another doctor. But if they’ll answer your questions, engage with you, you get comfortable with the doctor, then you start to feel the doctor’s got your best interests at heart and when you feel your doctor has your bests interests at heart I think it calms you down a little bit and helps you make good rational decisions.

Stephanie Chisolm:

How about you, Bob?

Patient Advocate Bob W.:

I don’t think that I can really add too much. I agree with what’s been said. I had experience when I came to Dr. Shore, I had experience with cancer before some years ago. I had prostate cancer. So I had some experience with what went on and I was also fortunate to have a good bunch of medical people that were involved with me in that cancer. I had good experience there so I came with good experience about this. My only question was, really, “Am I going to make it through this? What should I do? How should I approach this?” It wasn’t so much of what I should do to this or that, but I trust the physician that he knows what he’s talking about. My questions are usually very basic questions. No, I don’t think I have anything that really stands out.

Stephanie Chisolm:

So, doctors, I think that you are perfect examples of the kind of care and research oriented clinicians that are doing this work because you have very inquisitive minds, you want to know, and you want to make this better. Is there one common question that you think every patient should ask a research team when they’re considering being in a clinical trial? Have you gotten one of those perfect questions like, “Gosh, that’s a great question. Everybody should ask that?”

Patient Advocate Bob W.:

Well, I think your question might be, “How is this going to affect the care that I would get otherwise?”

Stephanie Chisolm:

That’s a good question.

Patient Advocate Bob W.:

Because Dr. Shore said to me right up front, “I’m going to take care of you.” And I took that to mean that regardless of what’s going on in this test I come first and I think that… The other doctor’s kind of mentioned that in his conversation there, that the patient comes first instead of the trial.

Patient Advocate Bob W.:

I mean, the question is… My question is, “How does this affect the treatment that you’re going to give me anyway?”

Stephanie Chisolm:

Right. Okay. So, Dr. Shore, do you have one perfect question that you’ve been asked that you think everybody should ask?

Dr. Shore:

Before I answer that, Mr. Wrenn, unfortunately every time he’d come in he had this really great walking stick or what I call a shillelagh, and I used to compliment him on it all the time. One day he brought me one and I have it and it’s one of those joyous things that you get out of the clear blue sky. I know Peter’s had that experience, too. It’s what makes being a physician and helping people such an honorable and joyous profession.

Dr. Shore:

I think I would say to… Here’s one thing I say to all of my colleagues who do research is you want to have as many studies so that if you’re really dedicated to treating bladder cancer that you have enough of a spectrum covering all of the different areas, like you were talking about before Stephanie, the non-muscle invasive, to the muscle invasive, to the advanced, so that you have a potential study for every bladder cancer patient. That, to me, is when you get to a level of excellence. Not everybody’s there in the beginning, but that’s a really great place to be so that every patient who comes in as a trial patient until proven otherwise. I firmly believe in that because that’s how we’ll advance healthcare.

I guess the question that I would ask from a patient standpoint is say, “Doctor, if you’re doing clinical studies, tell me what you’re experience is, what your team’s experience is with this study because I want to make sure that I’m in good hands.”

Stephanie Chisolm:

Okay, great. Dr. O’Donnell, do you have anything to add to that?

Dr. O’Donnell:

Yeah I’ll say… You asked what the most important question to ask is, I actually think the most important question to ask is asking your doctor, “Do you have clinical trials?” Or, “Should I be thinking about a clinical trial at this point in my care?” Because while Dr. Shore and I do this all the time and every day, not every oncologist is thinking about clinical trials all the time so it sometimes is the patient that needs to speak up and say to their doctor, “Doc, should I be thinking about clinical trials?” Or, “What can you tell me about clinical trial options?” You’d be amazed, if you ask that question as a patient, how your doctor might respond. They might open all these doors to them realizing, “Wow, this patient wants to know about some of the emerging treatments, the latest treatments,” and it leads to a whole conversation of them mentioning to you the things that are going on or sending you to a doc that can answer that question better. Whereas you might have been just restricted to some of the standard treatments if you didn’t speak up.

Stephanie Chisolm:

Great, inquiring minds want to know and you don’t know what options are there, what doors you could open, unless you ask. I think that’s a really important question to ask.

Stephanie Chisolm:

Let’s talk a little bit about really recruiting representatives from all different races and ethnicities and why it’s sometimes as challenge but why is it so important that we really have representation of all people in a clinical trial? Dr. O’Donnell, you do a lot of research, Dr. Shore, you do as well. What are the efforts to really try to be inclusive and diverse in these trials so that we’re representing all people who have bladder cancer?

Dr. O’Donnell:

This is so important. I mean, it goes beyond just the patient that you’re helping in front of you but this is where, and patients do feel this. They feel like they’re helping the greater cause. I’m amazed and my patients tell me that all the time. They say, “Doc, even if this trial doesn’t help me maybe I’ll help someone in the future.” But really in order for this to help many, many people in the future we have to have adequate representation across the diversity spectrum, across the gender spectrum, across the age spectrum, to be able to understand what patients are really going to benefit from this kind of treatment. Including those patients in the trials is so key.

Stephanie Chisolm:

Dr. Shore, anything else to add?

Dr. Shore:

I would echo those comments. Racial and socio-economic and ethnic disparity has unfortunately plagued a lot of our clinical trials throughout all of oncology. And ASCO and the AUA and ESMO and EAU, all the leading organizations, it’s a very high priority to get much greater diversity of our patients because sometimes we see not everyone benefits. There may be differences in Asian populations or Middle Eastern. Of course there could be difference even amongst men and women. Getting patients of color more involved is hugely important. I know it’s a really big initiative within BCAN. We really want to reach out to many of our populations that have bladder cancer. Maybe they’ve been suspicious of studies because of historical grievances that were wrong, but for all the reasons we’ve talked about, you get cutting edge treatment, there’s an economic potential advantage, but more importantly it’s just really cutting edge therapy and that’s how we’re going to solve the unmet needs in bladder cancer.

Stephanie Chisolm:

Well, this has been incredibly beneficial. I’m going to see if there’s any other questions that are out there from the participants. I think there was one question. It’s really more of a comment talking about they are going through treatment for BCG, for non-muscle invasive, and it’s good to know that there are treatment options even in the non-muscle invasive space. That was really it. I think that this has been such a phenomenal discussion. I appreciate everyone sharing. Kevin and Bob, this has been wonderful to have your voices included. And Bob, I kind of wish we somehow figured out how to turn your camera so we could see your face but we have been able to hear you so this is a good thing.

Patient Advocate Bob W.:

You probably don’t need to see my face anyway.

Stephanie Chisolm:

Oh, we did see you briefly. Yay. It’s good to see your face. Okay. This is wonderful. Thank you so much.

Patient Advocate Bob W.:

Before we go, can I make one comment?

Dr. Shore talked about the walking stick. The reason that I gave him that walking stick was when he informed me I had cancer he said, “I want to see you in three months,” he said, “Before you come back I want you to do me a favor.” And I said, “What’s that?” He said, “I want you to take your shillelagh and go up on the Appalachian Trail and take a walk.” That’s why I brought the cane. I brought it to him. I said, “You take the walk because I’m not walking on the Appalachian Trail.”

Stephanie Chisolm:

Well, at least you’re out there walking. I know because he said you’re very active and I think that this is wonderful.

Patient Advocate Bob W.:

He’s very kind.

Dr. O’Donnell:

You know, it does take some courage. It does take a lot of bravery for a patient to be willing to do a clinical trial and I can tell you that I have many, many patients that are here today, alive today, because they were brave enough to take that step. Kevin, if I can say, I think that you’re one of those, for sure. I’ll just add my thanks to Mr. Wrenn, Mr. Williamson, for doing this today. It could help so many patients.

Stephanie Chisolm:

Absolutely.

If you ask about a clinical trial because you’re very interested and you’re doctor says, “Don’t worry about it. I’m going to take care of you. You don’t need a clinical trial,” and you really want to explore clinical trials, you can find clinical trials at BCAN.org. And for those who might be looking for clinical trials outside of the United States you can visit clinicaltrials.gov and there are clinical trials that are listed all around the world there. Thank you all so much.

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