It’s when a team of scientists and doctors tries a new medical treatment, drug, device, or method on a group of people to test how well it works. Right. If you are considering participating in a clinical trial, ask about your insurance coverage before you make your decision to begin the trial. Otherwise, there are coordinators and people who can make sure that all of that gets to the research nurse and gets in the hands of the person who is going to take care of that. They are available to patients with all the different cancer stages and offer treatment alternatives not just as a last resort. I think that it's always just good to have more education, so whatever venue we can give that to people, whether it's talking one on one with their physician or nurse or whether it's online, to give people permission that they can get more information. When you take part in a clinical trial, you add to our knowledge about cancer and help improve cancer care for future patients. I received all of my care through the clinical trial locally at the Lacks Cancer Center here in Grand Rapids. It is often thought that clinical trials are a last resort, but they may in fact be a good way to begin your treatment and receive excellent care from the very start. Thank you for being with us. And I think, you know, most of the time, 80 to 90 percent of the time, I'm able to answer patients' questions and concerns regarding their guinea pig concern, and most of the times actually it's related to the fact that they don't want to undergo extra tests or procedures that they wouldn't have otherwise. And we do have some clinical trials that are exploring brand new mechanisms of a drug that have never been used before. Mary Ellen, first of all, thank you so much for being with us. So it depends on the trial. But not knowing about them is a big problem. For patients who are highly motivated and want to explore novel ways of treating cancer, clinical trials satisfy that urge, Dr. Olajide says. For patients in clinical trials, their cancer treatment is under careful watch of a team of medical professionals. “First, I had to complete my treatment plan,” McCloud says. How is the Safety of Clinical Trial Participants Protected? Absolutely. It was life-saving for him, and that is Pat Gavin. That’s how you’ll get care that’s most appropriate for you. Pat, what's a final comment from you? She's a lung cancer specialist and also a head and neck cancer specialist, very active in trials. Summary. Well, every time I talk I say I'm alive today by the grace of God and the fact that I participated in a cancer clinical trial. Clinical trials testing potential medical products are commonly classified into four phases. Or, Pat, who feels he's alive because of that. Carey Anders, MD, is a medical oncologist with UNC Cancer Care. Sign up now to save articles, get E-News, become a part of the Patient Power family, and take control of your health. So people have a doctor, maybe the one who diagnosed them, and they have a close relationship with them, and they're afraid of losing them. …principal investigator to try to get some clarification of that. CiteScore values are based on citation counts in a range of four years (e.g. Here are some important things to know. And so I think it makes them feel really good that people have these connections. We thank Astellas, Amgen and Abbvie for their support. This field is for validation purposes and should be left unchanged. So there's a very thorough review of clinical trials, and these are vetted through several committees both in terms of ethical review as well as scientific review. So, Pat, one of the things I wonder about is there are people who are on modern therapy now like for instance some of these drugs we mentioned, people are doing well on ibrutinib or people are doing well on venetoclax, or people are doing well on some of the lung cancer drugs. UNC Cancer Care and UNC REX Cancer Care collaborate on clinical trials and offer them for several types of cancers, including: Patients in cancer clinical trials typically receive treatment that’s considered “standard of care” for their type of cancer, plus treatment that goes beyond standard of care—for example, a drug that’s not available outside of the trial. April 27, 2020. Who should join clinical trials: Any time you or a loved one is diagnosed with cancer you should also look at clinical trial alternatives. I think they like to know they've talked, they like to know that everybody's on the same page and this many more layers of care take care of that. Okay, Pat. So we've covered a lot in our first one, and we have another program coming up late in June. So one was where you get a placebo, so we heard no. You're about to meet folks from across the U.S. and wherever you're joining us. You must see that a lot. You know, we have patients who travel across the country that might have a genomic mutation. Well, that trial is absolutely the reason I'm here today. Dr. Aggarwal, was this a good start? Are clinical trials a “last resort” for cancer patients? So you're always going to get either standard of care or a combination that includes standard of care and the test drugs or the—test drugs. And I'm living with two cancers, chronic lymphocytic leukemia, where there are many new drugs now, and now we're looking at trials with combinations of new drugs. Can there be more partnership, or are more trials available now in the community as well? Dr. Aggarwal, thank you for joining us. Now, can a major medical center like yours help a patient discover the financial issues related to them, maybe even work with their insurance company to see are there options for them related to being in a trial? Last resort cancer immunotherapy treatments should become first choice, experts say after trial success ‘Unbelievable’ results could translate to years of extra life for some patients Once they see promising results, they conduct clinical trials in people. I think there's always a feeling that I'm going to be just a guinea pig, and that's the one thing I think I hear most often from people is I don't want to be a guinea pig. Fortunately, today I think patients are getting more knowledgeable about trials that are out there, and they're hearing more and have the interest in joining a trial, and they'll recommend it to their oncologists and tell them that they are interested. Certainly. Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. CiteScore: 3.7 ℹ CiteScore: 2019: 3.7 CiteScore measures the average citations received per peer-reviewed document published in this title. It tests a drug called palbociclib to see if there’s success treating women who have McCloud’s type of breast cancer (ER-positive, HER2-negative) and who are considered to be at risk of relapse. Clinical trials are sponsored or funded by sources such as physicians, hospitals, foundations, pharmaceutical companies, advocacy groups, universities and government agencies. And certainly in the area of lung cancer and many other cancers now there's a lot happening, and smart researchers like Dr. Aggarwal are trying to prove some things that really seem like they would make a lot of sense, but we patients have to participate, be their partner. When you’re comparing very sick patients to healthier patients, the effect of the treatment is hard to see because it may be obscured by important differences such as age, diet, cigarette use, heart disease or obesity. So if we want progress and cures for the cancers that we're living with, we've got to work with folks like Mary Ellen, Dr. Aggarwal and the other folks involved in research around the world, really. I think we definitely look forward to more patient participation on further trials, further programs like this. Okay. Now, Pat, what do you think are some of the myths? I just wanted to share my own personal experience as an example of how a clinical trial can at times be a "first resort." In open-label trials, both patient and doctor know what the patient is taking. Count on us for updates on the coronavirus and guidance for cancer patients and family members. Learn more about them: Need a doctor? Well, one of the big myths out there is that there's going to be a placebo arm, and there are not placebo arms to treatment trials, unless the standard of care would be a wait and watch, which is relatively rare. Is it the fact that they don't want to get the investigational drug, or is it the number of tests that are involved in association with receiving that drug? Video – Clinical Trials. Well, now joining us I think is Mary Ellen Hand, who has been at the Rush University Medical Center in Chicago for many years and also works with lung cancer patients but has been in oncology for many years. Here are three cancer screenings you shouldn’t postpone during the pandemic. How does that work? The Clinical Trial MythBusters series is a Patient Empowerment Network program produced by Patient Power. It's okay. My oncologist described it as we had the experience of witnessing a miracle. They may be looking for second or third generations of drugs, and so those people may travel. People often use this type of trial as a last resort. Pat, thank you so much for joining us on this program. Great program. Cancer Clinical Trials Don’t Have to Be a Last Resort. Thanks for having me, Andrew. Centralized patient interaction: It is common for the biopharmaceutical industry to use a number of different technologies, processes, and vendors to accomplish specific functions in a clinical trial. Maybe you could tick some off. Visit the link below to find UNC Health Care providers. And the goal is also to make this easier for patients. Ideas for clinical trials usually come from researchers. Are clinical trials only for patients who run out of treatment options? But Dr. Olajide says she would like patients “to be thinking about clinical trial options at the outset” of their cancer treatment. She joins us from Penn Medicine, the Abramson Cancer Center in Philadelphia. Dr. Aggarwal, let's go over that. Lola Olajide, MD, is a medical oncologist with UNC REX Cancer Care (with locations in Raleigh, Wakefield, Cary, Garner, Clayton and Smithfield) and a clinical professor of medicine at the UNC School of Medicine. And I want you to meet our first guest. Right. I was fortunate to have one of the original ones here in Grand Rapids by the Cancer Research Consortium, and those trials are available in academic centers, they're available in community cancer centers like I had. Pharyngeal head and neck cancer, in 2007, right? There are some trials that prohibit previous therapies or previous ibrutinib, for example, prior to enrolling in a combination clinical trial, and there are some trials that allow prior participation. And, in fact, we do facilitate meetings with a financial counselor so that if a patient has concerns about what will be covered versus what will not be covered will be discussed at length with a financial counselor. That's correct. Clinical trials are not a “last resort” There are thousands of clinical trials taking place around the globe. In general, many clinical trials are covered by insurance. And here at Penn we are actually trying to make this process very, very transparent so that when I discuss a clinical trial with a patient actually our consent forms reflect what will be the standard of care costs and what will be sponsored by the clinical trial. And thanks for the research that you're moving forward with and your devotion to patients with cancer. Clinical trials involve testing new drugs or … And, you know, when my patients say to me I don't want to be a guinea pig, I really try and figure out what is it about the trial that they don't want to do? We hope that—well, we know it makes a big difference, and we look forward to you having great discoveries in partnership with patients moving forward. Here's a question for Pat. Clinical trials involve testing new drugs or devices in an effort to discover breakthrough treatments. And I would ask what type of trials are available for people with my cancer, and what would you recommend as far as the trials that you see out there that you think is right for what I'm facing today? Pat and I told the story of each of us thinking we wouldn't be alive if we hadn't been in a trial. And so I think that that's a misconception that many people have. It's often a good way to get a new medicine that isn't available to everyone. How can that work where they can be in your trial but maybe some testing or some other things, or do they have to commute to your institution maybe from a distance all the time? You're welcome. Well, you know, this is a series we're doing, and so we've covered some ground today, and I just want to recap a couple of things. Clinical trials are done to make sure new treatments & procedures are safe and effective for people. There are many decisions to make regarding treatment, and it can be difficult in those circumstances to think about anything beyond that. “For me personally, it has been extremely rewarding to offer patients this option,” says Dr. Olajide. So I would say that each clinical trial is different in terms of how they're designed and what eligibility criteria are outlined. We are getting questions. In this section you can learn about clinical trials in general, find tools to help you decide if a clinical trial may be right for you, and search for specific studies you may be eligible for. We talked about the phases of trials. And so he says, are we likely to run into problems with clinical trials if you're on Medicare? Myth: Clinical trials are a last resort when all other treatments have failed. To further awareness and ultimately encourage more participation, read Dr. Frenck's 6 reasons why clinical trails are important. Find an oncologist near you. December 11, 2017. And they help us improve the quality of life for people during and after treatment. So we certainly do that. Good, good point. So I think what he's speaking particularly to is the co?pay of some of these medications is so very high, and co?pay assistance programs are not always built to support and help them in this. Clinical trials are studies of new drugs, procedures and other treatments in people. And so I mentioned I have chronic lymphocytic leukemia. Thank you so much for being with us. So sometimes it's just educating people that, you know, if they're not very sick, there's time to get more information. Tell us a little about the process of deciding whether you're going to have a trial at your institution at all. It is definitely happening more and more. We'll talk about that in June. They're the reason why you and I are alive today. 25 Interested. Researchers still use human volunteers to test these methods, and the same rules apply. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. We're here for a conference. Now, some of the pharma trials may be a little more isolated and localized to specific hospitals for some of their early?phase trials. Here in Chicago we're very collegial in head and neck cancer and lung cancer and, you know, multiple other cancers. What do you say to people? You know, if the trial exists five miles from here, we'll facilitate the patients getting on that trial there. What do we want to leave people with, hopefully have more people think about trials, get access to them and have greater participation? So, Pat, another concern—well, I guess one limitation of people being in trials is people don't even know about them, you know, not only don't understand what a trial is but have not even been told that it's an option, and that's a problem in the U.S. today, isn't it? Cancer, Clinical Trials. The drug development process will normally proceed through all four phases over many years. Author of the article: Tiffany Mayer. Absolutely. So, Mary Ellen, any guidance about that, Medicare patients and trials? And that actually has gone a long way in allaying some of the concerns that patients have when going on clinical trials. Researchers often conduct tests in a laboratory on animals first. I want to make sure that I'm getting a treatment and not being exposed to things that are unsafe. I think you call it an investigational review board. Their problem, their knowledge, all of us together, so. All right. Some even look at ways to prevent diseases from happening. I didn't know that a trial was going to be available in my home town. Do you believe it made a big difference for you? Thanks to our wonderful partner, the Patient Empowerment Network, and also the Coalition for Clinical Trial Awareness and the Alliance for Patient Access. The pandemic can be especially scary when you’ve already survived a health crisis. This isn’t your last resort. So while the administration of the drug and the monitoring of the drug may happen at the academic center, there are many tests and imaging procedures that can occur in the community. That included five months of chemotherapy, a double mastectomy and seven weeks of radiation therapy. Right. I even think it was a problem for me. We talked about genomics. Let's start with you, Dr. Aggarwal. What do you think are some of the things that people just think are true but really aren't? Now, if there are patients that have standard of care as observation, then, of course, that observation arm does become our randomized arm. Dr. Aggarwal, you have a lot of research going. Okay. It was a trial like many others that are in the national clinical trials network, and the NCI-sponsored trials are generally available at the NCORP sites, and there are a lot of those around the country. Hello and welcome to this Clinical Trials MythBusters program. So if a patient is 25 miles away, I try not to drag the patients here just for a clinical exam or just for a scan. These patients can find hope in new treatments offered only through clinical trials and satisfaction in knowing their participation may lead to safer, more effective treatments for future patients. COVID-19: A ‘last resort’ breathing machine prototype heads to clinical trials. I think over the last couple years in particular things have become much more complicated for people. Hosted by. This came in from George, who also has CLL. If an infusion needs to be done onsite, that's what happens. If it wouldn't have been for my oncologist recommending it to me, I probably wouldn't have joined. In my case, hormonal treatments quit working in early January and I needed to get on chemo asap. Consider trial designs (e.g., virtual trials, adaptive designs, crossover trials) that can simplify the study without compromising the quality of clinical data collected. Dr. Anders says at least one of her patients has taken part in three clinical trials. So there are lots of things and lots of procedures where we work synergistically with their community physician hand in hand to try and facilitate all of these procedures so that they don't have to keep traveling all the time. Our next program will be coming up on June 21st, and we're going to discuss are clinical trials a gamble? We talked about financial issues, and there are counselors to help you related to that. Thank you for being with us. Are Placebos Still Used in Clinical Trials? Whether it’s a vitamin, cancer drug, surgical procedure or medical device, researchers must test it on people to see if it will be successful. It’s perfectly OK for patients to participate in more than one clinical trial, but they must complete one trial before they will be eligible to enroll in another, Dr. Anders says. And, secondly, I will have people who have an out?of?network insurance or something that doesn't allow them the flexibility to maybe even come to our institution or somewhere else for their therapy, and they think cancer trials are free care, anything you get if you're on a trial is free. Dr. Aggarwal, lung cancer is a good example, but you're an oncologist, and you see many different areas that are changing fast. Could a clinical trial be a better match than current treatment options? This Cancer Research UK video talks about clinical trials. And then instead of knowing that it's a great opportunity for us to advance the body of knowledge but it's also—we're always encouraging and hopeful that people can get onto a clinical trial. Now, Pat, I want to go over a little background about you. I think there is, in some cases, a bit of a misconception that clinical trials are a last resort for our patients. So what's another myth, do you think? The sponsor of a clinical trial—such as the drugmaker—typically pays for that part. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. As we understand the biology of diseases better and as more medicines are available to us, the only way to access them and the only way to get FDA approval is through clinical trials. The clinical trial could inconvenience you. And I can tell you, in so many areas of cancer now there's exciting research going on. I think that medical records, one of the many—one of the most common medical records systems is available at many institutions across the country, so people can have access to the reports for another hospital. 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