Jaime Lewis (Host): Meaningful Medicine is a Novant Health podcast, bringing you access to leading doctors who answer questions they wish you would ask. From routine care to rare conditions, our physicians offer tips to navigate medical decisions and build a healthier future.

Novant Health is a leader in clinical research with 1,500 North Carolinians involved in more than 300 clinical trials at Novant Health facilities across the state. Dr. Franklin Chen is a medical oncologist and principal investigator of multiple clinical trials at Novant Health Cancer Institute. Today I'm sitting down with Dr. Chen and we're going to be talking about clinical research and who can participate. Before we get started, Dr. Chen, I'd love to know how clinical research became a passion of yours and what made you want to become a cancer physician?

Dr. Frank Chen: Thank you very much. A passion of mine has always been to bring the best care to our cancer patients, and you really can't have a conversation about bringing the best care without involving clinical trials. Our best therapies are discovered on clinical trials and many times our patients can't wait for the therapies of tomorrow.

 They need it today. And this is our ability to be able to bring tomorrow's cancer treatments to them, in a meaningful, timely manner. I was inspired to go into oncology by, as well as for many other doctors through, great mentors and I had a cancer professor in residency who was just absolutely inspiring and I love the type of patients that we were taking care of and the advanced type of therapies that my professors were able to deliver. So that inspired me to go into the field.

Host: Fantastic. Well, let's start talking about clinical trials then. What is a clinical trial and aren't there different phases to the process?

Dr. Frank Chen: Yeah, that's right. So, the clinical trial mechanism is a way for us to study and investigate drugs that are not yet FDA approved. These are promising drugs that may be able to treat our patients, give them meaningful cures potentially, as well as alleviating a lot of their pain and suffering.

So, these have to undergo a very scientifically rigorous process. And there are many different phases. There are three phases to clinical trials. Phase one, where we begin investigating these drugs to humans for the first time. And these are usually small trials that may comprise five, 10, or 15 patients.

If it is deemed safe, it moves on to phase two clinical trials, where it is a little bit bigger and we start looking at efficacy, in addition to continuous safety monitoring. And if it continues to do well and shows promise, it is a phase three clinical trial that patients enroll on where they are many times, much bigger trials, sometimes many hundreds, and even for bigger trials, thousands of patients that enroll on the clinical trials.

And if it demonstrates efficacy, then it finally undergoes the FDA approval process. This long process of what it takes to bring a drug to development so that everybody can enjoy them. And really a passion of mine has been to be part of this process, which can be quite labor intensive, but it's the right thing to do in order to bring the best care to our patients.

Host: Who can participate in a clinical trial and when is that recommended?

Dr. Frank Chen: So right off the bat, potentially, everybody can participate, and I think that's one of the things that I want to get out into the community. Sometimes people think that they have to have exhausted all options before they should look at clinical trials, but we have clinical trials that enroll patients at diagnosis, sometimes second or third line. So I would say always ask your oncologist if you are eligible for a clinical trial. Because again, one of the things we want to do is enroll as many patients as we can in order to bring them the best therapies, but also advanced science and medicine at the same time.

Host: Right. Well, you already sort of touched on this, but is there a list somewhere of available trials and can you just sign up or should you talk to your doctor to get registered?

Dr. Frank Chen: Yeah, of course the government has a clinical trial list of all the clinical trials that are available in the country, but the best way to do is just approach your oncologist and ask them what clinical trials are available in your institution. And all our oncologists are well versed in what we have and hopefully can match them with a clinical trial that's fit for them.

Host: Well, I understand patients may have some reservations about participating in clinical research. What are a few of the most common questions you receive about that?

Dr. Frank Chen: Yeah, some of the common things are sometimes people say, Oh, am I going to be a guinea pig? And that's throw back to the days of where many trials were all placebo controlled. And, as modern medicine has modernized the clinical trial process, it undergoes a very rigorous process, where we randomize patients, if it's appropriate, to usually standard of care therapy.

Nobody is gonna get a non therapy, unless it's appropriate. And it is usually matched up against a clinical trial drug that shows promise. So a lot of times I say talk to your oncologist, ask all the questions you can, so that you feel comfortable about enrolling into a clinical trail.

Host: Can you share a little bit about clinical research at Novant Health? What gets you excited to go to work every day?

Dr. Frank Chen: Yeah, at the end of it all, it always centers around the patient. One of the things as a hospital and a cancer clinic that develops and delivers advanced care, is that our patients don't have to travel to traditional academic centers that may be very, very far away. A lot of time, as well as resources, are used to do that.

And what we like to do is to bring the most advanced care that includes clinical research right here in the community, right at home. And so we're very proud to have the ability to deliver clinical research from phase 1, 2, or 3, meaning that even at the most difficult clinical trial delivery parts, we can deliver it here at Novant Health.

So that is what really inspires me to be able to continue to look for clinical trials to partner with different companies as well as organizations to deliver the advanced clinical trials that our patients may need right here at home in their community.

Host: So exciting. Well, isn't cancer research when we talk about it, isn't it ultimately about finding a cure? Are we close to that? What do you think?

Dr. Frank Chen: You know, that's a very good question because many times we ask the broad question, have we cured cancer or are we close? And cancer is many different diseases. And because of clinical research, we have come close and sometimes even cured or functionally cured some of these cancer subtypes. So what we try to do is to be able to make advances in all the subtypes of cancers, all the various tumor types, whether they're solid tumors, whether they're hematologic or blood cancers; they all have different areas that need a lot of investigating, meaning, us to perform more clinical trials, but we certainly have done very, very well in certain tumor types and we continue to need to do better, in other tumor types.

Host: Well, thank you so much for speaking with us on this very important subject, Dr. Chen.

Dr. Frank Chen: It's my pleasure.

Host: To find a physician, visit NovantHealth.org. For more health and wellness information from our experts, visit HealthyHeadlines.org.