 So our final talk today is by Jamie Anderson, who is our clinical research navigator, really able to help you and I and the Cancer Institute help you navigate through the process of clinical trials. Where are you? You want to come over here? No. Welcome, Jamie. Thanks, Dr. Figlin. Thanks, everyone, for being here, and thanks to the Kidney Cancer Association for having me. Thanks. Coming up. Okay, so my talk is going to be on clinical trials, and I'm going to give my presentation in two ways. So the first part, I'm going to go over some slides with frequently asked questions, and the second part, I'm actually going to show a clinical trial video that we made here at Cedars-Sinai. So first of all, how important are they? Essentially every therapy that we have today was once studied as part of a clinical trial. So you've heard about these kinds of therapies all day today, targeted therapies, immunotherapy, chemotherapy, new ways to deliver radiation, new surgical techniques, and clinical trials also help us come up with new treatments for side effects from cancer or side effects from the treatments that we use to fight cancer. When can you participate in a clinical trial? One of the physicians alluded to this earlier, there's a myth that clinical trials are only a last resort when everything else has stopped working, but it's actually not true. There are typically clinical trials available at every time point, so whether you're newly diagnosed, your cancer has come back once, twice, three times, and of course there are trials for patients who have tried all standard therapies and nothing is working. How do you know if you're eligible for a clinical trial? So each trial has specific eligibility criteria. There's usually a couple dozen of these. They are specific to each trial, but however there are some standard criteria, which I'll go over in a second. A lot of people ask me why do you have these eligibility criteria, because sometimes they're very strict. So the reason why we have standard eligibility criteria is because when we study a new treatment, the patient population has to be the same. If the patient population is the same, then we know that the result of the new treatment, whether it's a good result or a bad result, is directly due to that treatment itself and not due to any unique factors to the patients who are taking the medication. So these are the standard eligibility criteria that you'll find for trials. Of course, as I said, there's a few more depending on which protocol it is, but if it's an adult trial, it's 18 years of age of older. They're going to look at your tumor type, the stage of your disease, your ability to perform your daily activities. This comes up a lot when I talk with patients. This is basically your ability to take care of your daily needs as far as can you make yourself something to eat? Are you working a little bit? Can you bathe yourself? Can you go to the bathroom? Because sometimes I have patients call who their family member's bedridden, they've tried all treatments and they can't actually get into the clinic for a consultation. And clinical trials will exclude this type of patient. They also look at blood tests and or urine tests. They want to know how's your organ function? How's your liver? How's your bone marrow? Also your treatment history. How many treatments have you had and what were they? What are the different phases of trials? Dr. Amita went over this pretty well. Some of our slides are similar. You might recognize them. So I'll just kind of skim through them. So he talked about phase one trials and we're really asking, is this drug safe? Yes, it's usually the first time that this new treatment is being tried in people. However, sometimes it's two FDA approved medications being used together for the very first time so they don't know how they interact yet. They're trying to find the safest dose and it is possible that it could benefit patients. But that's not the main goal of phase one. The main goal is to find a safe dose. So phase two, how well does it work? Dr. Amita also touched on this. In phase one, it's tested against many solid tumors most of the time. If there is any tumor types that stand out, it looks like this drug might be effective against them. They're brought into phase two. So you could have the same drug with separate trials for kidney cancer, brain cancer, lung cancer, and then they're really trying to see how effective is this new treatment. Phase three is really the pivotal phase for clinical trials. Is it better than what we currently have? This is typically the phase where A plus C would be involved if there is one and I have a whole slide dedicated to that, I'll touch on that in a minute. And also randomization. Phase four, it doesn't sound like a very scientific question but it really is, did we miss anything? By now doctors can write prescriptions or chemo orders for this medication. Many people have taken it because it's FDA approved and they're looking at the long term side effects of the drug and also how it's reacting across many different people. Because now people all over the world usually have had it. Do cancer patients get placebo? Yes, sometimes. Placebos are designed to look exactly like the real study medication. So neither the doctor or the patient knows what they're taking. And I put a picture up here. You can see they look identical. It's something very important to note and I'll elaborate on this. You'll never get a placebo alone in a cancer trial. It's always gonna be in combination with the best known treatment for your disease. However, it's very important to note some diseases such as early stage kidney cancer, observation might be the standard treatment or there are some cancers out there. There is no known standard treatment. So that's the only scenario where you could potentially get a placebo alone but you're not missing out on anything because standard treatment is not to do anything at all. Are there any costs? So clinical trials have events, meaning lab tests, doctor visit scans that can either be charged to insurance or the trial itself. Standard of care costs are those things that you're gonna have done whether you're participating on a clinical trial or not. So if you have a cancer, you're being seen for treatment, you're gonna have doctor visits, you're gonna have lab work, you're gonna have scans, all of those things actually get charged to insurance as per the norm. However, if there's anything extra that the research trial requires, maybe it's an extra lab test, maybe it's an extra scan, that would get paid for by the clinical trial. The information about who pays for what is gonna be covered in the consent form of the trial. And right now I will give you the lowdown on consent forms. So it's a document which can be several pages in length and I mean several, sometimes that's usually between 20 and 30 pages. It explains the trial in detail but it has a lot of good information. In it you're gonna learn the purpose of the study, why you're being asked to participate, how many patients are taking part in the trial whether nationwide or worldwide, which procedures are paid for by the trial, which go to insurance, potential side effects, when you need to come in for your doctor or nurse visits, who to call if you get sick. And also importantly, your right as a research patient, including your right to withdraw at any time. You and the doctor are both gonna sign this document if you want to participate in a trial. This is the question I get most often. Will I be a guinea pig? The answer of course is no. Clinical trials are simply another treatment option for you to consider. Actually in most instances you're monitored much more closely on a clinical trial than you would be if you were getting standard of care. So don't take it from me, let's listen to the patients. So there were two pretty big studies conducted a few years ago that I wanted to share with you. The first one is from the Journal of Clinical Oncology. This is a very prestigious journal. They looked at about 1,100 colon cancer patients taking part in a chemotherapy trial. They found that 95% said participating was worth it and they would recommend a trial to others. 90% would do it again. And 65% actually said that their quality of life improved. The second study was done by the Coalition of Cancer Cooperative Groups and this actually was done in 1,800 cancer clinical trial participants and they found that 91% would recommend a trial to others. 92 had a positive experience and 96% felt they were treated with dignity and respect. And I don't know about you but that 96% sort of cancels out the guinea pig concept for me. What are the advantages and disadvantages? I honestly can't answer that question for you. It's very individualized, it's between you and your doctor and it depends on your personal disease. However, I can't give you the short list. Potential advantages, this new treatment may help fight your disease. You may be among the first to benefit. You have a chance to help other people in advanced cancer treatment. And then potential disadvantages. The new treatment may not be better than what we currently have. It may work for other patients and not for you and there could be some unknown side effects that we're not familiar with yet. So the significance of trial participation. It's kind of sad but less than 5% of adults participate in cancer clinical trials. Among those who do participate there are disparities. There are fewer minorities. There are fewer women and fewer elderly patients. And I wanna show you a contrast. If you're a child diagnosed with cancer in the US and some other countries and your physicians are participating in the Children's Oncology Group which is a worldwide cooperative group of physicians. I think it's about 3,100 and they're all working together to find a cure for childhood cancer. You don't have a whole bunch of options to choose from. Your standard of care is a clinical trial. So according to the Children's Oncology Group, more than 60% of pediatric patients are enrolled on clinical trials in contrast to about 3% of adults. Because of this high number over the past four decades the five year survival rate for childhood cancer has actually improved from less than 10% to nearly 80%. But are clinical trials right for everyone? The answer is no. You absolutely have the right to choose the direction of your own care. However, I feel when available, clinical trials should always be presented as another treatment option. That way if you decide not to participate you're making the decision on your own accord. Meaning the cards are all out on the table. You've been given the options and you're taking control of your treatments. How do I find information about trials? I actually printed this slide and it's on the front table. When you guys go you can take it so you don't have to scramble down to write this. But I have information, Kidney Cancer Association, a couple years ago they launched a great clinical trial matching service on their website. And then of course I'm gonna be available afterwards for any questions. We're actually gonna play the video now. And it was put together by patients, doctors, nurses, coordinators here at CEDARS. And I hope you guys enjoy it. Lung. Breast. Bancreas. Kidney. Prostate. Colon. Carcinoid. Leukemia. Glyoblastoma Multiforme Stage 4. And it was a scary diagnosis. Cancer can touch everyone. Your daughter. Your mother. Your son. Your sister. Your husband. Your wife. The future impact of cancer on the American public is growing. As our population ages, cancer will become a bigger and bigger problem. Cancer will soon overtake heart disease as the leading cause of death for Americans. One in every three women, one in every two men can expect a cancer diagnosis in their lifetime. One out of every three of us. One out of every two of us. All of the best treatments we have today to fight cancer were once clinical trials. All of the best. Not just a few, but all of them. Every therapy that we have available today had to go through a series of developmental clinical trials. We have many better options now than we did 20 or 30 years ago. All our major advances in cancer have been due to clinical trials, advances in surgery, advances in radiation, advances in medical oncology, new drugs, targeted therapy. The cure rate for childhood cancer is more than 80%. And this is all because of clinical trials. When I was diagnosed with leukemia, I was six years old. I knew I'd cancer, but I didn't know that it was a really, really bad disease. My parents decided to put me into the clinical trials because the reason why the numbers are so high where kids survive leukemia today is because kids have taken part of clinical trials in the past. Everyone is standing on someone's shoulders. And so if someone hadn't come before us or my wife and done what they did, and then she wouldn't have the opportunity to do what she decided there to do. We would not have any of the treatments today, standard of care treatments that all of our patients can benefit from if patients before them had not been generous with our time and their spirit really, and gone on to participate in a trial. I feel privileged to be working with patients who are participating in clinical trials. Their commitment, their dedication is, it's extraordinary. Becoming a member and a participant in the clinical trials enabled us to have 10 years additional together and a better quality of life for those 10 years. So far I've felt very comfortable and I really feel like this drug has saved my life. Clinical trials are always about helping you, the person that's participating. Yes, we will use that information to assist us in understanding a disease and helping others, but it always is about helping you. If we don't continue to do clinical trials, we will not find the cure. And I think we owe ourselves and our future generation, our kids, to do better than that. I think if there was one word I'd use to describe a clinical trial, it's about hope. Possibility. Heroic. Essential. Important. Science. I think of the word Karitas. And Karitas is a nursing term from a nursing theorist and it means caring with hope. Clinical trials may not be for everyone. But they might be for you. So ask your doctor. So ask your doctor.