Nearly every breakthrough in treating and curing disease is the result of a patient who was willing to participate in a clinical trial.
Life-saving treatments and medications that are common today began as an idea that led to a research study.
By participating in a clinical trial, you can help our doctors and scientists take the next steps in discovering new ways to treat and prevent cancer.
Suzanne Arnold, MD is here to answer questions about clinical trials and how as a volunteers you can take an active role in their care and help advance medical knowledge.
Learn how to participate in a clinical trial
Clinical Trials: What Patients Need to Know
From the Show: UK HealthCast
Summary:
Air Date: 7/6/15
Duration: 10 Minutes
Transcription:
Melanie Cole (Host): The UK Markey Cancer Center is committed to developing new and more advanced ways to fight cancer and utilize breakthrough technology to maintain and improve your quality of life from diagnosis to recovery. My guest today is Dr. Susanne Arnold. She’s the Associate Director for Clinical Research at Markey Cancer Center at the University of Kentucky HealthCare. Welcome to the show, Dr. Arnold. Tell us a little bit about clinical trials. People hear the word clinical trial and they think placebo, they think it’s not something that’s going to help me. Tell us what are clinical trials.
Dr. Susanne Arnold (Guest): Well, thank you for having me and thank you for bringing up this important issue because clinical trials is a scary concept when you’ve just been diagnosed with lung cancer or other cancers. I think one of the important things to remember is that every drug that is FDA approved right now, that people take on a routine basis, was the subject of a clinical trial before it became publically available. So, that’s how we make progress and how we actually decide on what treatments are best for people as they are treated for cancer and all other medical diseases. I think that people hear the word “trial” and they get worried they are going to be offered placebos or just going to be “experimented” on and I want to allay their fears about that. Clinical research in this day and age is actually a very, very highly regulated and highly protected area. We spend many, many more hours protecting subjects and watching out for their care when they’re involved in clinical research than people did in the 1950’s or 1930’s, when there was much less oversight by the FDA and the National Cancer Institute and all the Federal regulatory bodies that care for and watch over research that people are going through. So, I think it’s a time now not to be afraid but a time to be excited because all of the new interventions and all of the newest discoveries that are hitting the press now, really are living in a world of clinical research now, especially in cancer.
Melanie: Well, they certainly did and clinical trials lead to these life saving treatments that you’re discussing. So, how does somebody go about deciding if they are a candidate for a clinical trial? Do they wait until they’ve tried all of the mainstream options or do they look to the clinical trials as a first line of defense? How does that work?
Dr. Arnold: Yeah, that’s a really good question. So, when you’re diagnosed with cancer it’s a very scary time and you may meet with a multitude of different doctors who are going to be taking care of you. The multidisciplinary care of cancer is standard now. Each of those physicians will probably outline for you clinical treatment options that are best for you, often in cancer centers and in larger NCI designated cancer centers. Clinical trails will be offered to you at the beginning of your treatment and throughout your life as a cancer patient. Some studies and some clinical research is now being done at the very beginning of someone’s treatment. It’s not only at the end of an exhaustive list of standard treatment. Those clinical research questions that are beginning to unlock the genes that drive cancer are being brought forward into earlier treatments, like at the time of surgery or as a first line treatment in metastatic disease because they’re being shown to be safe and effective and perhaps even less toxic than some of our standard clinical care that we use all the time like chemotherapy. So, it would not be a surprise to me for someone to meet their doctors, hear about the treatment options and actually be offed participation in a clinical trial even at the beginning of their therapy and that’s appropriate in some situations.
Melanie: If they are offered a clinical trail, Dr. Arnold, does then insurance perk up its ears and say, “Well, this hasn’t been tested,” or “We will not pay for this”? Or, you know, because right when you get that diagnosis, not only is it so scary but you start to worry how you’re going to pay for everything.
Dr. Arnold: Right. So, if you’re offered participation in a clinical trial, the very first thing that happens is that you are given the information about the trial and asked to provide informed consent through a written document. That is something you use as a living document throughout the time that you participate in a trial. Within that document will be descriptions of what would be paid for by insurance, what might not be covered by insurance, and what will be paid for by the study itself. It’s very variable as to what each trial will allow and what insurance companies will allow. So, we always tell people to check with their insurer before they sign a consent for clinical trial. Most clinical trails in the majority of cases are actually a shared responsibility where the standard treatment and the standards of care like CT scans and lab tests are covered by insurance, whereas the experimental agent or the biopsy or the experimental plan would be covered by the clinical trail itself. But each of those is very different and it’s a very complex field. So, what I would tell people is one, you don’t have to participate in a clinical trial but if you choose to do so, read the consent very closely and also talk to your insurer about whether or not there will be unforeseen costs. We try very hard in clinical research to not have anything that’s unforeseen and try to be very clear and spell it all out in those consent forms.
Melanie: So, are there certain people who you’re just going to say, Dr. Arnold, are not candidates for clinical trial? “I’m sorry this trial is for end stage” or “You’re in end stage and this is for newly diagnosed.” Are there certain things that make a candidate?
Dr. Arnold: Yes. So, each trial has some things that are called eligibility criteria. We have to make sure that each patient that’s put on a clinical trial meets the eligibility criteria of that particular trial. What that means is, if this is a study that’s looking at relapsed non-small cell lung cancers, Stage 4, then someone that just had a surgery and doesn’t have that stage of cancer won’t be eligible for that trial. So, we, as researchers, are responsible for making sure that a person meets the eligibility requirements of the trial before they’re offered that trial. That’s something that your scientific team and your clinical care team should be able to determine for you. It’s also important to note that there are going to be people who are too weak or too frail to participate in certain clinical trials and that may not be something that everyone’s aware of: that you do have to have a certain amount of health and ability to withstand the treatment, just like you would for standard treatment, when you participate in a clinical tria9l.
Melanie: Are there such things placebos now in clinical trials? Do you have control groups? Is there a chance that if you’re someone whose been diagnosed with cancer, you could end up in a control group?
Dr. Arnold: It would be very unusual to have a placebo group in a clinical trial in cancer in this day and age. The only time that that’s actually something that could be a possibility would be if there are no known treatments for someone in the fourth or fifth line cancer spectrum for their particular cancer and if there was going to be a placebo arm, it would be outlined in that consent form. So, no one has ever given the possibility of being randomized to only a placebo, and if there was a placebo involved such as, if you’re receiving chemotherapy and you’re going to either get chemotherapy plus the treatment or chemotherapy plus the placebo, that would be outlined in the trial. But, it’s unethical to provide a cancer patient with placebo by itself in this day and age. I just don’t think it would happen. But, it’s always outlined in that consent if there’s going to be a placebo that is going to be involved and that very unusual anymore.
Melanie: Does being a part of a clinical trial make it so that other treatments are then not an option? Or, are they still out there but there might be medication interactions or treatments that don’t go with one another? How does that work?
Dr. Arnold: So, when we have a clinical trial participant, we outline for them not only the clinical trial options for them, but also we outline for them the other treatment options: palliative care, systemic chemotherapy, radiation as part of that consent process. I always tell people, if you are participating in a clinical trial and it doesn’t work, I'm going to have X, Y, and Z as our back up options. It doesn’t really burn any bridges to participate in a clinical trial; it actually offers you the chance at getting some newer medication that might work better than the standard. There are always back up plans. That’s one thing oncologists are really good at, is developing back up plans for our back up plans. If something does not work, this will be the next thing that we try. So, I think most oncologists will have that dialogue with their patients and reassure them, that they are not burning any bridges. In fact, sometimes doing the clinical trails first gives them an opportunity they would otherwise not have.
Melanie: That’s absolutely great information and so fascinating, Dr. Arnold. In just the last minute if you would, give patients your best advice about their curiosity about clinical trials and why they should come to the UK Markey Cancer Center for their care.
Dr. Arnold: So, I think we’re in an evolution and a revolution in cancer care, in that we are unlocking the secrets to why cancers occur and they’re very specific. Each person’s tumor has a very different genetic landscape than the next person’s tumor and each person’s treatment, therefore, needs to be very targeted and designed specifically for them. Individualized patient care is a difficult thing to do in isolation and a cancer center has a great deal of support and infrastructure to help diagnose and set up treatment plans that are based on individuals’ needs and their genetic landscape. If I have cancer, I'm going to go to a place where I can be taught, given the newest information, get the best drugs available, and have a good understanding of why my cancer occurred. I think that happens in big cancer centers like ours. So, that’s what I think is important and it’s a really exciting time. Cancer is a really scary diagnosis but there are going to be cures for cancer that no one even imagined 20 years ago because of all the research that’s done in cancer.
Melanie: Thank you so much for great information. You’re listening to Advances and Insights with the University of Kentucky Healthcare in Lexington, Kentucky. For more information on clinical trials available at the Markey Cancer Center, you can go to UKhealthcare.uky.edu. That’s UKhealthcare.uky.edu. This is Melanie Cole. Thank you so much for listening.
Melanie Cole (Host): The UK Markey Cancer Center is committed to developing new and more advanced ways to fight cancer and utilize breakthrough technology to maintain and improve your quality of life from diagnosis to recovery. My guest today is Dr. Susanne Arnold. She’s the Associate Director for Clinical Research at Markey Cancer Center at the University of Kentucky HealthCare. Welcome to the show, Dr. Arnold. Tell us a little bit about clinical trials. People hear the word clinical trial and they think placebo, they think it’s not something that’s going to help me. Tell us what are clinical trials.
Dr. Susanne Arnold (Guest): Well, thank you for having me and thank you for bringing up this important issue because clinical trials is a scary concept when you’ve just been diagnosed with lung cancer or other cancers. I think one of the important things to remember is that every drug that is FDA approved right now, that people take on a routine basis, was the subject of a clinical trial before it became publically available. So, that’s how we make progress and how we actually decide on what treatments are best for people as they are treated for cancer and all other medical diseases. I think that people hear the word “trial” and they get worried they are going to be offered placebos or just going to be “experimented” on and I want to allay their fears about that. Clinical research in this day and age is actually a very, very highly regulated and highly protected area. We spend many, many more hours protecting subjects and watching out for their care when they’re involved in clinical research than people did in the 1950’s or 1930’s, when there was much less oversight by the FDA and the National Cancer Institute and all the Federal regulatory bodies that care for and watch over research that people are going through. So, I think it’s a time now not to be afraid but a time to be excited because all of the new interventions and all of the newest discoveries that are hitting the press now, really are living in a world of clinical research now, especially in cancer.
Melanie: Well, they certainly did and clinical trials lead to these life saving treatments that you’re discussing. So, how does somebody go about deciding if they are a candidate for a clinical trial? Do they wait until they’ve tried all of the mainstream options or do they look to the clinical trials as a first line of defense? How does that work?
Dr. Arnold: Yeah, that’s a really good question. So, when you’re diagnosed with cancer it’s a very scary time and you may meet with a multitude of different doctors who are going to be taking care of you. The multidisciplinary care of cancer is standard now. Each of those physicians will probably outline for you clinical treatment options that are best for you, often in cancer centers and in larger NCI designated cancer centers. Clinical trails will be offered to you at the beginning of your treatment and throughout your life as a cancer patient. Some studies and some clinical research is now being done at the very beginning of someone’s treatment. It’s not only at the end of an exhaustive list of standard treatment. Those clinical research questions that are beginning to unlock the genes that drive cancer are being brought forward into earlier treatments, like at the time of surgery or as a first line treatment in metastatic disease because they’re being shown to be safe and effective and perhaps even less toxic than some of our standard clinical care that we use all the time like chemotherapy. So, it would not be a surprise to me for someone to meet their doctors, hear about the treatment options and actually be offed participation in a clinical trial even at the beginning of their therapy and that’s appropriate in some situations.
Melanie: If they are offered a clinical trail, Dr. Arnold, does then insurance perk up its ears and say, “Well, this hasn’t been tested,” or “We will not pay for this”? Or, you know, because right when you get that diagnosis, not only is it so scary but you start to worry how you’re going to pay for everything.
Dr. Arnold: Right. So, if you’re offered participation in a clinical trial, the very first thing that happens is that you are given the information about the trial and asked to provide informed consent through a written document. That is something you use as a living document throughout the time that you participate in a trial. Within that document will be descriptions of what would be paid for by insurance, what might not be covered by insurance, and what will be paid for by the study itself. It’s very variable as to what each trial will allow and what insurance companies will allow. So, we always tell people to check with their insurer before they sign a consent for clinical trial. Most clinical trails in the majority of cases are actually a shared responsibility where the standard treatment and the standards of care like CT scans and lab tests are covered by insurance, whereas the experimental agent or the biopsy or the experimental plan would be covered by the clinical trail itself. But each of those is very different and it’s a very complex field. So, what I would tell people is one, you don’t have to participate in a clinical trial but if you choose to do so, read the consent very closely and also talk to your insurer about whether or not there will be unforeseen costs. We try very hard in clinical research to not have anything that’s unforeseen and try to be very clear and spell it all out in those consent forms.
Melanie: So, are there certain people who you’re just going to say, Dr. Arnold, are not candidates for clinical trial? “I’m sorry this trial is for end stage” or “You’re in end stage and this is for newly diagnosed.” Are there certain things that make a candidate?
Dr. Arnold: Yes. So, each trial has some things that are called eligibility criteria. We have to make sure that each patient that’s put on a clinical trial meets the eligibility criteria of that particular trial. What that means is, if this is a study that’s looking at relapsed non-small cell lung cancers, Stage 4, then someone that just had a surgery and doesn’t have that stage of cancer won’t be eligible for that trial. So, we, as researchers, are responsible for making sure that a person meets the eligibility requirements of the trial before they’re offered that trial. That’s something that your scientific team and your clinical care team should be able to determine for you. It’s also important to note that there are going to be people who are too weak or too frail to participate in certain clinical trials and that may not be something that everyone’s aware of: that you do have to have a certain amount of health and ability to withstand the treatment, just like you would for standard treatment, when you participate in a clinical tria9l.
Melanie: Are there such things placebos now in clinical trials? Do you have control groups? Is there a chance that if you’re someone whose been diagnosed with cancer, you could end up in a control group?
Dr. Arnold: It would be very unusual to have a placebo group in a clinical trial in cancer in this day and age. The only time that that’s actually something that could be a possibility would be if there are no known treatments for someone in the fourth or fifth line cancer spectrum for their particular cancer and if there was going to be a placebo arm, it would be outlined in that consent form. So, no one has ever given the possibility of being randomized to only a placebo, and if there was a placebo involved such as, if you’re receiving chemotherapy and you’re going to either get chemotherapy plus the treatment or chemotherapy plus the placebo, that would be outlined in the trial. But, it’s unethical to provide a cancer patient with placebo by itself in this day and age. I just don’t think it would happen. But, it’s always outlined in that consent if there’s going to be a placebo that is going to be involved and that very unusual anymore.
Melanie: Does being a part of a clinical trial make it so that other treatments are then not an option? Or, are they still out there but there might be medication interactions or treatments that don’t go with one another? How does that work?
Dr. Arnold: So, when we have a clinical trial participant, we outline for them not only the clinical trial options for them, but also we outline for them the other treatment options: palliative care, systemic chemotherapy, radiation as part of that consent process. I always tell people, if you are participating in a clinical trial and it doesn’t work, I'm going to have X, Y, and Z as our back up options. It doesn’t really burn any bridges to participate in a clinical trial; it actually offers you the chance at getting some newer medication that might work better than the standard. There are always back up plans. That’s one thing oncologists are really good at, is developing back up plans for our back up plans. If something does not work, this will be the next thing that we try. So, I think most oncologists will have that dialogue with their patients and reassure them, that they are not burning any bridges. In fact, sometimes doing the clinical trails first gives them an opportunity they would otherwise not have.
Melanie: That’s absolutely great information and so fascinating, Dr. Arnold. In just the last minute if you would, give patients your best advice about their curiosity about clinical trials and why they should come to the UK Markey Cancer Center for their care.
Dr. Arnold: So, I think we’re in an evolution and a revolution in cancer care, in that we are unlocking the secrets to why cancers occur and they’re very specific. Each person’s tumor has a very different genetic landscape than the next person’s tumor and each person’s treatment, therefore, needs to be very targeted and designed specifically for them. Individualized patient care is a difficult thing to do in isolation and a cancer center has a great deal of support and infrastructure to help diagnose and set up treatment plans that are based on individuals’ needs and their genetic landscape. If I have cancer, I'm going to go to a place where I can be taught, given the newest information, get the best drugs available, and have a good understanding of why my cancer occurred. I think that happens in big cancer centers like ours. So, that’s what I think is important and it’s a really exciting time. Cancer is a really scary diagnosis but there are going to be cures for cancer that no one even imagined 20 years ago because of all the research that’s done in cancer.
Melanie: Thank you so much for great information. You’re listening to Advances and Insights with the University of Kentucky Healthcare in Lexington, Kentucky. For more information on clinical trials available at the Markey Cancer Center, you can go to UKhealthcare.uky.edu. That’s UKhealthcare.uky.edu. This is Melanie Cole. Thank you so much for listening.
