Prakash Chandran (Host): When you participate in a clinical trial, you don't just get access to cutting edge medical treatments, you get to help shape the future of healthcare one trial at a time. Today, we're going to discuss everything you need to know about clinical trials. And joining me is Stephanie Farrell. She's a registered nurse and Director of Research at Eisenhower Medical Center.

Host: Welcome to Living Well with Eisenhower Health. I'm your host, Prakash Chandran. So Stephanie, thank you so much for joining us today. I really appreciate your time. Let's get started with the basics. What exactly are clinical trials?

Stephanie Farrell: So, a clinical trial is a specifically designed research study to look at new medications and new devices to see how effective and safe they are. And every single medicine, every single device that's put in a patient goes through a clinical trial to determine if it's safe and effective.

Host: Okay. And out of curiosity, at a high level, why are clinical trials so important?

Stephanie Farrell: Without clinical trials, we would have no new medications, no new devices to help people. For example, in oncology, all of the new immunotherapies and targeted therapies that are making a difference extending people's lives, those are all a result of clinical trials. If you know anyone that's had a knee replacement or a hip replacement, all of those devices that get people back to their golf and tennis, those are a direct result of clinical trials.

Host: So, what it seems like is that there are always clinical trials that are going on, right? Like to basically make sure that the new in innovations in medicine are tested. They have longstanding, I guess, evidence that they are actually effective.

Stephanie Farrell: That's correct. I mean, every day, there are hundreds, probably thousands of clinical trials happening all over the country and honestly all over the world for every type of condition.

Host: Okay. Talk a little bit about the different phases of a clinical trial and typically how long they last.

Stephanie Farrell: Okay. So, there are four phases of clinical trials when we're testing new drugs. Phase I is a small group of people, usually around up to 20 people looking at safety of that new drug and how to deliver it. And it can last for about six months to a year. And then once a drug's deemed safe, it's moved into phase II. And a phase II clinical trial will include more patients, you know, maybe 20 to 50. And it's additionally looking at safety and then efficacy, how well is this drug doing to treat this disease? And once the phase II trial is successful, it moves into a phase III clinical trial. And this is where we're comparing the current standard of care to this new drug. And those can last, you know, anywhere from one to five years, even longer, and really looks at this is what may change the future of how we treat this condition if the trial goes well. And then, phase IV is once the FDA gives an approval to a new drug, they do additional studies just to look at in the real world, outside of the healthcare setting when people are taking their medicines, and you know how we all are, it's like, maybe I forget to take my pill today, which is much different when you're on a clinical trial and being managed, they look at how it works in a real world setting with patients.

Host: Okay. So, these four phases are pretty much why it takes a long time for new drugs to come out, but I think people can feel confident that there is a rigor and a structured way that new treatments are tested, right? Just to make sure that they're safe for broader distribution.

Stephanie Farrell: Very, very rigorous, very structured, very safe. There are multiple checkpoints. When people enroll and volunteer to participate in a clinical trial, you really do as a patient, you get a higher level of care when you're in a clinical trial because you're being monitored so closely by your physician and by the research team.

Host: Got it. You know, I know that there are sometimes some myths that exist around clinical trials. Can you speak to some of them and perhaps debunk the ones that are not true?

Stephanie Farrell: Yeah, I think the biggest one that I hear about is, "Oh gosh, I'm going to be a Guinea pig" or, you know, "They're going to put me on a placebo," and I will assure you that a patient would never be put on a placebo if there were a good treatment for their condition. It would be unethical. And there's an ethics committee or an institutional review board that looks at all of these studies and makes sure that there's benefit and safety for patients. So, very unusual that you would get a placebo when there's a drug available. And you truly are getting a higher level of care. Even for my own parents, with their conditions, they're getting up into their 80s, I always direct them to talk to your doctor, see if there's a clinical trial for your condition, your psoriasis, your diabetes, your hypertension, because you're going to get better care if you're in a trial.

Host: Yeah. So, just expanding on that a little bit, can you talk to us a little bit more about the types of clinical trials that might be available at Eisenhower?

Stephanie Farrell: So, Eisenhower does mostly treatment trials where we're actually looking at novel new therapies to treat conditions like cancer, heart failure, arrhythmias, atrial fib, orthopedic conditions, new knees, hips, spines, shoulders; HIV treatments and so instead of, you know, pills, getting an injection every couple months. Pulmonology, we have pulmonology clinical trials and neurology clinical trials. You know, just think of all the different conditions that people get as they age, and we have clinical trials in most of those areas. And it's always changing. It's always changing.

Host: Yeah. That's incredible. And I know you spoke to this a little bit before you started to touch upon the fact that when you're in a clinical trial, you obviously get a higher level of care because, you know, you have multiple people that are monitoring you, they want to make sure that things are going well for you. Can you talk a little bit more about the other potential benefits of participating in a trial?

Stephanie Farrell: So, not only are you followed very rigorously, structured, getting all of your safety labs done and your imaging and your visits with your physician, but typically the physicians that participate in clinical trials, they are the leading physicians in their field. It's a lot of work to do clinical trials and these are kind of the best and the brightest who take on this and are trying to advance care for the conditions they're treating. So, that's one of the things, physicians.

The other part is you get access, access to new drugs and devices right here in the desert. You know, 10, 20 years ago, you might have to drive out, you know, two and a half hours to a big tertiary center to get the best care, and that's not necessarily true. Eisenhower is doing clinical trials that the best and the brightest centers across the country are doing.

Host: That is so cool to hear. Now, you talked about that four phases of a trial, the first kind of being the safety phase. I imagine that when patients undergo a clinical trial, maybe they have a preference to say like, "Hey, I hope that this is past phase I, and we're just thinking about efficacy at this point." Do you ever hear that or is there a certain bar or rubric that Eisenhower uses in terms of deploying clinical trials?

Stephanie Farrell: So, I would say when we're having a discussion with a patient, it's called an informed consent discussion. We spend about an hour with them and talking about what's involved, what the potential risks are and really weighing those. There is absolutely no pressure on patients to participate in clinical trials. We have a very thorough discussion about, you know, if this is right for them. And typically, we are not doing phase I trials so much. Most of our clinical trials are in phase II and phase III. But for some people, a phase I trial might be the very best treatment for their cancer. If they've exhausted all other options and there is nothing out there, then a phase I trial might be right for them. And that's something that they really have to talk to their family about and say, you know, "Should I give this a try? Is it worth trying?" And knowing that we're going to be monitoring them very carefully to make sure that if there are any side effects, we know those right away and get them taken care of.

Host: Yeah. I think at the end of the day, people want hope, right? And there's so many people working on these innovative treatments, and if they have the ability to at least be considered for one of the treatments as long as there's a comprehensive discussion, understanding the pros and cons, then I see no reason, especially if they have the free will to choose why that's a bad thing.

One thing I did want to expand on, you talked about potential risks. Can we talk a little bit more about, you know, commonly what those are and how you speak with patients about them?

Stephanie Farrell: Sure. So, you know, the new drug may have risks and maybe it'll lower your blood count or affect your liver. And the way we mitigate that is we do routine testing. You know, we're going to ask you to come in for lab tests and maybe a little bit more often than you normally would, and that's to look at safety. And if we notice that your labs are abnormal and meet a certain threshold, we're going to put the drug on hold until you recover. Those are the way we monitor patients with either labs or imaging. We're trying to find side effects early before they get severe and manage them.

You know, another risk of being in a clinical trial is of course the drug may not be effective. And that is when I talk about the informed consent, it's just having a good discussion with the patient about all their options. And this is one additional treatment option that they have to consider.

Host: So, you know, Stephanie, you mentioned the very close monitoring of patients throughout the trial to make them feel comfortable, but can you just expand a bit more on how patients are protected to reduce any risk, especially some of the ones that you spoke about just now?

Stephanie Farrell: So in addition to the clinical monitoring that takes place, extra labs, we are regulated and monitored by the Institutional Review Board, which is in charge of patient safety, and the FDA. So, there are routine monitoring visits and audits where outsiders come in and look at the way that the trials are going to make sure that patients are safe. And I'll tell you, our mission in clinical trials is to keep patients safe. That is our first priority, first and foremost, is to keep a patient safe. And we have, you know, dedicated physicians and nurses that help do that.

Host: Now, one of the things that I was curious about are maybe any exciting advances that have actually come from a clinical trial. Can you share what outcomes or what exciting advances have come out of Eisenhower do to clinical trials?

Stephanie Farrell: So, let's see. Eisenhower has participated in clinical trials with the National Cancer Institute, and we were able to treat patients with immunotherapies and precision medicine more than a decade ago when those were not at all available. Now, those drugs are routinely used for advanced lung cancer, advanced melanoma. The changes I've seen in treatments has been remarkable just in my you know, experience with this. So, those are a couple things.

Additionally, in our cardiology area, they've had devices to monitor heart failure that they'll implant in someone's heart to try to prevent exacerbations and hospitalizations. There's very cool devices in a patient's heart that will transmit data to the cardiologist and let them know if they're starting to get ill and the doctor can change their medications around to help improve their life and keep them out of the hospital.

Host: You know, I imagine that it's also kind of a cultural thing in terms of clinical trials or maybe I guess what I'm trying to say is some hospital systems may have the philosophy of, "I only want tried and tested medicine. I'm not going to participate in clinical trials." But for Eisenhower, it really seems like there's some forward thinking to say, "Look, medicine is a constantly evolving field," right? And so, we as a system need to get on board with that. Do you find that that is the case?

Stephanie Farrell: Yes, I mean, clinical excellence is our true north, and we're so fortunate. We have philanthropy that helps support research. And many medical centers just can't afford to do it, especially single ones like ours. So, we have leadership that believes in it. We have physicians who are actively engaged and all the support to make it happen. It is very, very complex. Not everybody can do it. And we have the perfect nexus where all of this comes together to make it possible and support for it. It's unusual for a setting like ours. You would see this normally in a big academic setting, out in a big city. And we are just so fortunate to have all of these things in our desert.

Host: So, yes, Stephanie, how exactly do patients find out about clinical trials?

Stephanie Farrell: Well, there's a few ways. First and foremost, talking to their doctor. That's the best way. They can also go to the Eisenhower website and look for clinical trials to find those. And there's national websites. Clinicaltrials.gov has a listing of all the clinical trials.

Host: Okay. And if a patient is talking to their doctor, do you recommend questions that they should ask their doctor about receiving treatment in a clinical trial?

Stephanie Farrell: Yeah. Some of the questions I would recommend that patients ask would be, you know, talk about your condition. What are the different approved treatment options? How well do they work? Are there some promising new therapies out there that might work better? And if so, what are those and are they available here?

Host: Okay. And as kind of a followup question, like there might be people out there that might just be interested in participating in a clinical trial. Is that a thing? Can you talk broadly about if someone is healthy and they're looking to participate in a trial, what those dynamics are?

Stephanie Farrell: Yes, that is a thing. But I would say for the clinical trials that Eisenhower is doing, we are typically treating patients' diseases. But one of the ways, if people want to get involved in researching clinical trials and they have myChart, you know, that app that lets them look at their health record, they can actually go into myChart and click on research studies and they can learn about opportunities. They can fill out a profile that says, you know, "I'm interested in participating in healthy living or healthy aging or women's health." They can go in and select all these different options. So even if we don't have a clinical trial today, we may have one in six months in 12 months, so they can express their interest and we can contact them if something comes up.

Host: Love it. Well, Stephanie, just before we close here, is there anything else that you wanted to share with our audience about clinical trials and anything that we've covered today?

Stephanie Farrell: I think just know that every treatment available today for every condition is a direct result of clinical trials. And patients are such an important part of that and being willing to participate in clinical trials or at least exploring it. And so, have a good discussion with your doctor and know that there are many levels of safety and monitoring to keep patients safe while they do participate.

Host: Stephanie, I think that is the perfect place to end. Thank you so much for your time.

Stephanie Farrell: Thank you.

Host: That was Stephanie Farrell, a registered nurse and Director of Research at Eisenhower Medical Center. For more information, you can visit eisenhowerhealth.org/services/clinical-trials. If you found this podcast to be helpful, please share it on your social channels and be sure to check out the entire podcast library for topics of interest to you.

Thanks for listening to Living Well with Eisenhower Health, healthcare as it should be. My name is Prakash Chandran. And until next time, stay well.