Sam Gage, RN, clinical trial nurse at the Helen G. Nassif Community Cancer Center, joins Dr. Arnold to discuss cancer clinical trials. What’s the process, facts and myths about trials and more.
Dr. Dustin Arnold
Chief Medical Officer
UnityPoint Health – St. Luke’s Hospital
Clinical Trial Nurse
Helen G. Nassif Community Cancer Center
Dr. Arnold: This is LiveWell Talk On…Clinical Trial Research. I’m Dr. Dustin Arnold, Chief Medical Officer at UnityPoint Health – St. Luke’s Hospital. Our guest today is Sam Gage, she is a clinical trial nurse with the Helen G. Nassif Community Cancer Center. Thank you so much for stopping by.
Sam Gage: Thank you. It’s great to be here.
Dr. Arnold: One of the fundamental tenants of medicine is research that can lead to better outcomes and etc. And so, could you just explain what exactly is a clinical trial?
Sam Gage: Absolutely. So, cancer clinical trials are research studies that involve people and then they compare the most effective treatment for each type or stage of cancer with a new approach. So, there’s going to be a trial for every kind of cancer. And at the cancer center we offer a diverse selection of trials for patients and our patient population. We work with the Physician’s Clinic of Iowa and then also St. Luke’s Radiation Center to provide those clinical trials to patients.
Dr. Arnold: So, if a patient has the diagnosis of cancer, they present to the cancer center, let’s just say it’s cancer of the lung, then do you and the oncologist decide, well, we’re going to use this trial because of the patient’s characteristics versus this other trial for the patient’s care? Is that how that happens?
Sam Gage: Yeah, so we’re kind of behind the scenes. We’re looking at all of the patients that come into these clinics before they even see the providers to determine if there’s an open study for them. And then once we identify an appropriate study, we’ll go to that appointment and meet with the provider, talk it over with them, see if that’s the best approach, or if they want to do more of a standard of care therapy for that patient. So, we’re really there behind the scenes making sure that these opportunities are getting to patients at the appropriate time.
Dr. Arnold: So not all clinical trials are the same?
Sam Gage: That’s right. They’re not all the same. In fact, most people think that clinical trials are just for people that have advanced cancer, that’s not responding to treatment. But there are trials for all types and stages of cancer. So anytime that you have a loved one or yourself need treatment for cancer, it’s definitely good to consider a trial.
Dr. Arnold: So the patients are not blinded to, so this isn’t like a randomized controlled trial. This is a clinical trial. So, you’re, you’re following a protocol that on some level might be experimental to treat that cancer? Correct?
Sam Gage: Absolutely. There are different types of clinical trials. So, there are randomized trials where it’s like a one to one randomization. You’ll either get a medicine or you’ll get observation or you’ll get a new investigational drug or you’ll get a placebo. So, we do offer those opportunities. Those would be called interventional trials where you’re looking at a new investigational product to see if that’s better than the standard care.
Dr. Arnold: Okay. That’s interesting. I know about 30% of randomized controlled trials are refuted over time and 80 to 83% of non-randomized. So, this, I think people need to understand this is dynamic and changing. Science is never settled. Does the patient know that they’re in a clinical trial and can they say, and I’m just not interested?
Sam Gage: Absolutely. There’s no way to get on a clinical trial without knowing that you’re on one. There is a lot of safety measures put in place to make sure that patients understand exactly what it is to be on the study that they’re going to go on to. There’s an informed consent process that happens before any patient can enroll. So, we sit down with the patient, we go through this long document that tells them everything, the risks, the benefits, potential outcomes, and then they really have to make that decision themselves to participate. It’s all voluntary. Even if they sign up and then something happens in their life down the road and they can’t participate anymore, they have that option to drop out. So clinical trials really are driven by safety first and the first part of that is that the patient knows and understands exactly what trial that they’re getting onto.
Dr. Arnold: So they’re not, so they’re not guinea pigs.
Sam Gage: Absolutely. That’s a big misconception. Patients say that to me all the time. I don’t want to just sit there and be your guinea pig for some research study. But really there’s a lot of things that go into making sure that patients feel like they’re getting a safe and effective treatment. So, building that trusting relationship from the beginning so that they understand that they’re not just a lab rat, that there’s a lot of things that go into the research before it even gets to the clinical trial phase. There’s lab testing. They want to make sure that these therapies are actually effective in cancer cells before they even get to the point of coming to human contact.
Dr. Arnold: I always feel sorry for guinea pigs because they always get picked on when it’s usually mice anyway. So, you know, everybody’s like, I don’t want to be a guinea pig. Well, we don’t study guinea pigs usually, you know?
Sam Gage: No, absolutely. Fruit flies are popular.
Dr. Arnold: Yeah. Fruit flies. Other rodents. Are the clinical trials more dangerous or risky than standard therapy for treatment of a cancer?
Sam Gage: So, clinical trials are designed for research purpose. So, as a result, there’s some level of risk involved. But the investigational drugs in clinical trial participants are only given after they’ve gone through that long, rigorous scientific testing process. We want to keep patients safe. And so, there is an institutional review board that looks at all of the research before it even begins and throughout the whole process. So, that board is made up of a committee of doctors, scientists and community members who are responsible to protect all clinical trial participants. That’s really the way that we make sure that people are staying safe on these studies and that the drugs aren’t actually harming patients, that things are moving in the right direction in that area.
Dr. Arnold: Yeah. The institutional review, the local IRB, institutional review board, I as Chief Medical Officer, those members, I appoint them, and they take that very serious and have tremendous ownership in that process, which is good. I mean that’s what we want them to do. How can the patients find out more about clinical trials and whether or not they qualify?
Sam Gage: So a good way to start. If you’re interested in participating in a clinical trial and you have a cancer diagnosis or know someone that does, you can give our office a call. We are always happy to talk to you and look at different opportunities, see what’s out there for you. So, our direct number, if you want to give us a ring is (319) 368-5514 and that’s directly to the research department. So, we can go over any opportunities that might be available to you. And then on a broader scale, if you’re interested in looking at clinical trials that are offered throughout the nation or locally here, there is a website with a searchable database. It’s clinicaltrials.gov and legally, if you have a clinical trial open, you have to post it on that website. So, that’s really a good resource to look at all of the trials available here in the United States.
Dr. Arnold: And is there a reporting milestone during trials that you report, you know, at six months, this is what we’re seeing. And who was that reported to? The IRB?
Sam Gage: So the IRB will do yearly reviews with us. We have to continue to show that the research is being done correctly, that we’re following the protocol, that there’s no safety concerns, any adverse events that we have to report, we report to them. And then at the level of who designed the protocol or the clinical trial, they have interim data analysis where they’ll sort of do a hard stop on the data entry and everyone will sit down and evaluate, okay, what are the safety risks? Do we have any trends that are forming? Do we need to shut down this protocol or is it going in the right direction? Can we keep it open. So, those things are all kind of happening simultaneously as the protocol is going forward as people are enrolling.
Dr. Arnold: Yeah, because you do hear that when you read studies that you know, sometimes a trial is suspended or discontinued because of risk and other times it’s because it works and there’s no need to go on with the trial because we’ve proven that it does work. Which it really is exciting because this is how we continue to develop new medicines, new treatments, extend the longevity for people. People that have the survival rates for people that have cancer. I mean, in my 20 some odd years of practice, the survival rate, five year survival rate for lung cancer is phenomenal. Now, it used to be a single percentage, and as you know, like 30 or 40% depending on what type of lung cancer. One last question. What got you interested in the clinical trials over at the cancer center?
Sam Gage: So, as I got into nursing, as many people do because they want to help people in a time that they need it the most. And the nice thing about nursing is there are so many different avenues, different types of nursing roles. I really enjoy kind of figuring out the larger picture and understanding why we do what we do and why we treat patients a certain way. So, when I was looking for a career in nursing, I wanted to find something that kind of melded those two opportunities. So, I get to have that direct one on one patient care with these patients that enroll on a trial. And then also I know that the work we’re doing on a larger scope is really helping the benefit of the greater good to try and get those, the best therapies out there to people.
Dr. Arnold: Yeah, I think like a lot of things in life and particularly medicine, when you realize there’s, you’re part of a bigger story that’s unfolding, you take a lot of pride in that and that’s phenomenal.
Sam Gage: The patients take a lot of pride in that too. I think that’s one of the things that people don’t realize when they first sign up for a trial, how they’re going to feel and at the end of it, they always, that’s one thing I hear very frequently is that they’re happy to have been able to contribute on a larger scale.
Dr. Arnold: Yes, absolutely. I think it’s always admirable the degree of sense of duty that patients have when they’re in these scenarios. It’s, this job is about humanity. And each day I’m reminded of how phenomenal healthcare providers are as well as the patients. And it’s why I come to work every day. That’s really great information. Thank you so much for taking the time to come over and talk to me. Again, this was Sam Gage. She is a clinical trial nurse at the Helen G. Nasif Community Cancer Center. If you have a topic you’d like to suggest for a Talk On… podcast, shoot us an email at firstname.lastname@example.org. And we encourage you to tell your family, friends, neighbors, strangers about our podcast. Until next time, be well.