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Clinical trials are an important part of how your doctor cares for you better. Dr. Samir Kapadia and Dr. Kevin Hodges discuss why we have clinical trials, the advantages of being in a clinical trial and how to get involved. They explain that participating in a clinical trial does not prevent you from getting care and should not have any associated added costs.

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Will Being in a Clinical Trial Change My Care?

Podcast Transcript

Announcer:

Welcome to Love Your Heart, brought to you by Cleveland Clinic's Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute. These podcasts will help you learn more about your heart, thoracic and vascular systems, ways to stay healthy and information about diseases and treatment options. Enjoy.

Samir Kapadia, MD:

Hello everybody, welcome to our podcast today. My name is Samir Kapadia. I'm the Chairman of Cardiology at Cleveland Clinic. And I have with me, Dr. Kevin Hodges, Kevin.

Kevin Hodges, MD:

Hi, as he said, I'm Kevin Hodges. I'm one of the adult cardiac surgeons here at Cleveland Clinic. I specialize in all sorts of cardiac surgery, but I have a special interest in mitral valve repair and minimally invasive valve surgery.

Samir Kapadia, MD:

Thank you for being here, Kevin, and what we are planning to do today for the patients to try to explain to them, why do we do clinical research and what are the best ways that they can participate and what are the reasons why they should consider coming to a place where there are a lot of new clinical trials. So one of the ideas, maybe I ask you a first question to say that what are the kind of things that we are trying to investigate in clinical trials? Is it something that is very experimental or has been already been tested, such that we are providing more options to the patients?

Kevin Hodges, MD:

Yeah, that's a great question. Clinical trials range all through the sorts of treatment options that we have for cardiac disease. Some are about new medications. Some are about new devices and some are about new procedures. And clinical trials range as far as sort of how new the investigational device or procedure is in most cases. However, these are things that have already been studied pretty extensively. They may have had multiple even human trials leading up to that point. And these are large trials, usually for the FDA to approve the device for widespread use. So most of the time these aren't really experimental in the way that people might think of, this is something that's never been done before, but it's something that's been proven, but we want to use it in a large population to make sure that it works for everybody, and it has very good results.

Samir Kapadia, MD:

Yeah. And I want to stress one part that at Cleveland Clinic, since we are very involved in the new devices and new procedures and new surgeries, many of these things that are brought to Cleveland Clinic, we have some expert who already knows the device, who already has been working on the device for a long time. They actually understand that what are the best ways to utilize the device. So this really helps. So this decreases the risk of the procedure and provides new alternatives to the patients that usually they don't have these alternatives elsewhere. And this also increases the safety of the procedure because many of the things that we test are to make the procedures even safer.

Kevin Hodges, MD:

Yeah.

Samir Kapadia, MD:

So it is a good idea in my mind at least. If I have a family member, I always tell them that please participate in the trial. If people doing the trial are not learning at the same time, but they are actually involved in the development of the trial. And most of the trials that we do by definition, we only do it if we have a leadership role or we are involved in the trial to begin with.

Kevin Hodges, MD:

Yeah, I think that's a great point. And sometimes patients wonder whether they should participate in a clinical trial and they ask, "What are your motivations for offering me a clinical trial?" And I always tell people that when we offer a clinical trial it's because we think that the treatment in the trial is really the best thing for that patient. And sometimes the trials are designed so you don't know which you may get, the established treatment or the new treatment. And that's just sort of part of a trial, but when we offer a clinical trial to a patient it's because we think the new therapy is something that can really benefit them. So we like to benefit and learn from the science of these trials, but it's really more about offering what's best for the patients.

Samir Kapadia, MD:

Exactly. And I think the one question that a lot of patients ask us is to say that, "Listen, if I participate in the trial, there's a 50% chance of getting the treatment that you are testing and 50% not. Why should I? What if I don't get the right treatment?" What I tell them is that if you don't participate in the trial, then there's a hundred percent chance that you will not get the treatment. So at least this is the way to get a 50% treatment chance. And very importantly, we follow the other 50% on all of them, a hundred percent of the patients very closely. So there is always a crossover. There is always an opportunity to give the best treatment to the people, as soon as we learn that the treatment we provided is better than the older treatment, standard treatment. So I think this is a common question. I'm sure that your people ask you too that there's a 50/50 chance and how do I make sure that I'm in the right group? But that is the purpose of the study.

Kevin Hodges, MD:

Yeah. There's no way to guarantee which arm of a trial you might be in, otherwise, it wouldn't work, but I think what you say is right that if we're excited about a new therapy, often in the beginning that's the only way to get it is through a clinical trial until it's approved for widespread use, but usually the other arm is also one where you're going to get very close monitoring. Your doctors are going to take excellent care of you. And in most cases now the control arm or the non-investigational arm of a trial is a well-established therapy as well.

Samir Kapadia, MD:

Exactly.

Kevin Hodges, MD:

A good example, we both participate in aortic valve treatment.

Samir Kapadia, MD:

Exactly.

Kevin Hodges, MD:

And you may be in a trial of a transcatheter device versus a surgical device. Those have mostly been done now, but we make sure that either option is a good fit for the patient.

Samir Kapadia, MD:

Exactly.

Kevin Hodges, MD:

So we would never subject somebody to a risky situation or not treat a medical problem just for the sake of a trial.

Samir Kapadia, MD:

And see we are doing, as you know we are doing the... another example is the mitral valve, where Dr. Gillinov and you and others are using surgical expertise. And as everybody knows that surgery was the best surgery possible for the mitral valve repair and the same way the clip arm is where we are doing the clips, but again we have been doing the clips from 2004, 5. So this is both are very established treatments. We are trying to compare them and we are able to do this for the best patient and the best anatomical situation. So we are not trying to find out that, okay this will work or not, and putting somebody at risk. If we are confident that we can provide both treatments equally, then only we'll do this.

Kevin Hodges, MD:

That's right. Yeah. Now that's a great example of a trial where the treatment, the MitraClip is really not investigational at all anymore. And the trial is actually to expand the indication to more patients so that more patients can benefit from something. That's a great example.

Samir Kapadia, MD:

Now, the question, another question people are asking is that how would they know that they are a candidate for any trials in Cleveland Clinic? So what are the ways that they can figure it out that they are interested if they're interested in clinical trials?

Kevin Hodges, MD:

You know, that's a great question. So from a patient perspective, often patients are very well informed and they've looked these things up and they find them on the internet. The manufacturers of the devices and even the medical centers like ours have information available online about clinical trials. And people will come and ask us, "Am I a candidate for this or that?" And we always are open to all of those things, but usually your doctors will approach you and let you know that you're a candidate, and that's the main way. Our doctors are leaders in these trials and involved in the design and execution of the trials. And so they will come to you as a patient and say that they think you may benefit from a trial procedure or device or medicine and offer that to you.

Samir Kapadia, MD:

No, correct. And as you said that we do also have on our website the different centers. And all the centers also list the trials that we are doing. So if somebody's interested in trying to find out that for the aortic valve or mitral valve or for cardiomyopathy, what are the trials that Cleveland Clinic is doing, you can go to our website or centers and try to identify that what trials we are doing.

Kevin Hodges, MD:

And we love when people come with those questions because it just makes it a better conversation about all the options available. And we want our patients to be as informed as they can be.

Samir Kapadia, MD:

Now, the last question is that, what is the cost of the trial? And if people are interested, would they have to pay or would they have to bear the cost of the experimental device or the trial covers the cost?

Kevin Hodges, MD:

Yeah.

Samir Kapadia, MD:

And most commonly, most of the trials cover the cost. We make sure that the trials cover the cost. Patients should not have an additional cost for the trial.

Kevin Hodges, MD:

Yeah.

Samir Kapadia, MD:

And many times even the trial pay for the travel and the extra visits if they need it or any extra investigations that need to be done, the trial will cover it. So I don't think that the cost should be a major limitation in participating in a trial. And bring it up to the doctors to let them know that if it is because the trials can help you with the cost of the trial.

Kevin Hodges, MD:

Yeah. Generally speaking, Cleveland Clinic or even the manufacturers of devices or medications aren't trying to make any money off of a clinical trial. These are about expanding our knowledge and providing better care for our patients.

Samir Kapadia, MD:

That is wonderful. Thank you again for being part of this discussion. It was wonderful.

Kevin Hodges, MD:

Yeah. Thank you very much.

Announcer:

Thank you for listening. We hope you enjoyed the podcast. We welcome your comments and feedback. Please contact us at [email protected]. Like what you heard, subscribe wherever you get your podcasts or listen at clevelandclinic.org/loveyourheartpodcast.

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Love Your Heart

A Cleveland Clinic podcast to help you learn more about heart and vascular disease and conditions affecting your chest. We explore prevention, diagnostic tests, medical and surgical treatments, new innovations and more. 

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