Should you participate in a clinical trial
Clinical research is important to make progress in medicine. Dr. Nissen, Chief Academic Officer of the Heart, Vascular and Thoracic Institute, describes what you should know about randomized clinic trials and how they are being conducted during the time of COVID. When your provider approaches you about clinical research, take a moment to listen. Ask questions about the benefits and risks of trial participation. Dr. Nissen talks about benefits you may not have thought of.
- Learn more about clinical trial participation
- Search for clinical trials at Cleveland Clinic
- Search for clinical trials across the globe
Transcript
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.
I'm Dr. Steve Nissen, and I'm the chief academic officer for the Heart, Vascular & Thoracic Institute here at the Cleveland Clinic. I'd like to talk to you today about clinical trials. And that may be the last thing on your mind in the middle of a pandemic, but it's important to understand that research is how we make progress in medicine. And we've had to cope with the problems related to the COVID-19 epidemic while continuing to move forward to develop new therapies for patients.
The primary way we develop new therapies is using a technique known as randomized clinical trials. Now, these are typically trials in which patients are randomly assigned to either a new therapy or an old therapy, or sometimes a new therapy or a placebo, an inert sugar pill. Randomized clinical trials are really the primary way that medicine advances, because what happens in those trials is, the process of randomly assigning patients means that patients that get the new therapy and don't get the new therapy have similar characteristics. And then you can look and see who does better, patients that get an older therapy or a placebo, or patients that get a newer therapy.
In fact, the US Food and Drug Administration will generally not approve a new therapy without a randomized clinical trial because it's the gold standard. Now, it's a lot harder to do these kinds of trials in the current environment. Everybody's worried about going to see the doctor for their own health, and they're certainly worried about seeing a physician to participate in a clinical trial. But what we've done, and this is being done really all over the country, is people are adapting how these trials are done. People that come to the Cleveland Clinic for either clinical care or for research, they have their temperature taken, they're asked questions about their health, they're really, really careful that everybody has to wear a mask. And we've actually had no instance where any patient has actually developed a coronavirus infection by participating in clinical research. And we have thousands and thousands of patients involved in clinical research. So it turns out that it's actually very safe to do this.
We've also found new ways to stay in touch with patients. Instead of having in-person visits for follow-up in these clinical trials, we'll have a phone visit, or we'll have a virtual visit where the patient gets on their computer and we can look at them and see them face to face at a great distance. And we can talk about how they're doing. We can give them advice and assistance just as we do for regular clinical care. And this has enabled us to continue these trials.
It's important that we not abandon research under the current circumstances. The only way we advance medicine is by doing these kinds of studies. And whether it's to develop a new heart valve, or a new catheter technique for improving heart valve function, or a new drug therapy, these are all studies done with randomized clinical trials.
We have put a few of our studies on hold, where we thought that perhaps the risks were higher than the possible benefits. But most of our studies, after a brief hold, have resumed and they're moving forward. Many of these studies are global. They're taking place in countries all over the world, in Europe, in South America, and even in Asia and other countries. Each of the countries have their own rules and regulations, they have their own protections in place, and we've been able to safely proceed.
If someone approaches you to participate in a clinical trial, what we would ask you to do is listen, listen, to understand both the benefits and the risks of participation. And you might say, "Well, what's in it for me?" Well, there's a couple of things that may happen. One is, you may actually get the therapy and it may turn out that that therapy has major benefits and you'll be amongst the first to get it.
But I'm going to tell you about something else that researchers know about that actually is maybe a little bit surprising to people. There have been a number of studies of randomized clinical trials, looking at what happens to the patients who get the placebo, they don't actually get the new beneficial medication. And just being on a clinical trial, it turns out that people do better than people that are not in clinical trials. Why might that be? Well, when you're in a clinical trial, you have physicians and nurses that are looking after you very closely. They're seeing you frequently, they're talking to you, they're making a number of measures of your health. And it turns out that people that actually participate in clinical trials, even if they don't get a new medication that turns out to be beneficial, even if they're patients who are getting the placebo, they actually do better than the general population with those diseases.
So in closing, I would ask you to think about this carefully. Don't reject the idea of participating in clinical trials. Recognize that this is how medicine advances. And if you're somebody who wants to help with that advancement, go ahead and participate. Studies have shown that most people who participate in clinical trials are doing so because they believe that their participation will help not only them, but all of the other patients that have the same condition that they have. It's really quite a wonderful thing that people see the big picture, they understand that it's about all of us. And by participating in a clinical trial, even if you don't have a direct benefit, everybody else may benefit down the road. Society may benefit. Other patients may benefit. And most people, when they finish a clinical trial, feel really good about what they did, because they know they did something that's really helpful and beneficial to other patients and to society. Thank you very much for watching.
Thank you for listening. We hope you enjoyed the podcast. We welcome your comments and feedback. Please contact us at heart@ccf.org. Like what you heard, subscribe wherever you get your podcasts, or listen at clevelandclinic.org/loveyourheartpodcast.
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Should you participate in a clinical trial
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.