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. She is medical director of the UNC Breast Center in Chapel Hill, a member of the UNC Lineberger Comprehensive Cancer Center, and an associate professor of medicine with the UNC School of Medicine. No. I didn't know that a trial was going to be available in my home town. The clinical trial could inconvenience you. People often use this type of trial as a last resort. Sign up now to save articles, get E-News, become a part of the Patient Power family, and take control of your health. Hosted by. And she says since there's a four? Dr. Aggarwal, let's go over that. But I think that if he's going to be eligible for a clinical trial, he should, you know, number one see if he's eligible. So we have some people who are in watch and wait, okay. 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. A phase III clinical trial for the vaccine produced by Moderna is seeking 30,000 participants across the country. Count on us for updates on the coronavirus and guidance for cancer patients and family members. “Every time I go in for my clinical trial appointments, it makes me feel like I am actively fighting against my cancer.”, “I want to do everything I possibly can to keep my cancer from coming back,” McCloud says. Clinical trials involve testing new drugs or … You must see that a lot. But not knowing about them is a big problem. We are either randomizing patients to standard of care or meeting standard therapy, the chemotherapy, be it a pill, be it targeted therapy or immunotherapy, and we compare patients to that approach and introduce the experimental approach on the other hand. This is a worldwide broadcast we're doing. Some even look at ways to prevent diseases from happening. Get free recipes, health tips, information and patient stories once a month! So let me go over that with Dr. Aggarwal. To further awareness and ultimately encourage more participation, read Dr. Frenck's 6 reasons why clinical trails are important. Or you don't want to have your genomic testing done yet, and yet you've started chemotherapy. Are you thinking about participating in a clinical trial? 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. How is the Safety of Clinical Trial Participants Protected? And some people need to be well enough to travel, you know, if they need to—if the trial is out of our ZIP code. Let's meet one of our medical specialists who is joining us, who has been on our Patient Power programs before and our lung cancer programs, and that's Dr. Charu Aggarwal. And then at our hospital, and I'm sure across the country, we make sure that they get the imaging so that they have something to compare it to, and then that's uploaded into your chart, you know, at the other facility so that everybody has the right information to take care of the patients. What would you say to patients about the opportunity, like I said, did it give me tomorrow's medicine today? Now, none of us know how long they'll last, so they say, well, why should I even think about trials if it's not broken now? 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. Access to clinical trials can be a last resort for many Canadians. 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. 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. In open-label trials, both patient and doctor know what the patient is taking. Consider trial designs (e.g., virtual trials, adaptive designs, crossover trials) that can simplify the study without compromising the quality of clinical data collected. And so there's a clinical trial underway combining two of these oral agents, ibrutinib (Imbruvica) and venetoclax (Venclexta), is underway at MD Anderson in Houston, and the same trial is supposed to begin at Northwestern in Chicago near where Mary Ellen is, and that's in May. Dr. Aggarwal, thank you for joining us. Clinical trials also help us find new ways to prevent and detect cancer. Are there other myths that you can think of that you really want to talk about now? And they help us improve the quality of life for people during and after treatment. Mary Ellen spoke about that but from your perspective. Clinical trials are sponsored or funded by sources such as physicians, hospitals, foundations, pharmaceutical companies, advocacy groups, universities and government agencies. Explore 364,793 research studies in all 50 states and in 219 countries. Well, I'm over here in Europe, today in Barcelona. You can view and edit this list in your account. I think that's another thing, is that patients are concerned that their doctor, whom they've forged this relationship with and the nurse, they think they will be upset if they go somewhere else. Many clinical trials look at new ways to detect, diagnose, or measure the extent of disease. But if you want to get the possibility of tomorrow's medicine today, and it happened for me with chronic lymphocytic leukemia, being in a Phase II trial way back in 2000, 10 years before the drug combination I received was approved. Pat and I told the story of each of us thinking we wouldn't be alive if we hadn't been in a trial. It's often a good way to get a new medicine that isn't available to everyone. So from your point of view, what's a myth that comes up a lot for people? And also you were treated for melanoma 2008, and then in 2014 prostate cancer. 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. New FDA Approval for RET Positive Medullary Thyroid Cancer. You know, so I would facilitate them getting scans closer to home with their outpatient oncologist and then ask them to perhaps bring a CD with them for review. 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. What do we want to leave people with, hopefully have more people think about trials, get access to them and have greater participation? Clinical trials are research studies conducted with human patients. CiteScore values are based on citation counts in a range of four years (e.g. 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? One of the most recent assessments was performed by researchers at the MIT Sloan School of Management led by Charles E. and Susan T. Harris Professor Andrew Lo. The sponsor of a clinical trial—such as the drugmaker—typically pays for that part. Pat, what's a final comment from you? Publishing date: May 04, 2018 • • 2 minute read. 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. And I would urge patients to actually discuss and ask the facility where they'll be treated if there is such a person who can discuss with them, because most academic cancer centers do have this facility. Are clinical trials only for patients who run out of treatment options? 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? People I think are—have heard about trials for other illnesses, but we're talking about cancer now. 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? Thanks for having me, Andrew. 3 Things People with Allergies Need to Know About the COVID-19 Vaccines, 3 Things Parents Should Know About the COVID-19 Vaccines and Children. Let's start with you, Dr. Aggarwal. If you’ve been diagnosed with cancer, your doctor might bring up clinical trials as an option to supplement your treatment plan. 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. And so I think that that's a misconception that many people have. Doctors use clinical trials to develop new treatments for serious diseases such as cancer. If an infusion needs to be done onsite, that's what happens. In the last five years, we've had upwards of eight to 10 drugs approved for lung cancer alone, and it would not have been possible without patients' participation on clinical trials. 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. Mary Ellen, first of all, thank you so much for being with us. And that actually has gone a long way in allaying some of the concerns that patients have when going on clinical trials. Talk to your oncologist again. We talked about genomics. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Here are three cancer screenings you shouldn’t postpone during the pandemic. Some clinical trials are designed to study patients who have not yet received treatment, so some clinical trials might be your best “first line” treatment. We talked about financial issues, and there are counselors to help you related to that. They make a difference. 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. Well, I think it depends somewhat on the trial and where they're going to be available. That's correct. Good, good point. We have a lot to talk about in helping debunk the myths about clinical trials and hopefully raising awareness and understanding for you and your family, so you can consider a clinical trial and see whether it's right for you. Clinical trials help scientists test new drugs to see if they’re safe and if they work. 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. We've been talking a little bit with our other guests about whether with you get a placebo, no, whether you're a guinea pig, no. Of course, there's always a certain amount of risk with any trial that we participate in, but the chances of some of the things happening that you might see on the comedy TV shows just aren't going to be there. Or, Pat, who feels he's alive because of that. This Cancer Research UK video talks about clinical trials. Can there be more partnership, or are more trials available now in the community as well? In some instances, they may see progression on ibrutinib prior to combination therapy that is ibrutinib and venetoclax. 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. That’s not possible if a patient receives treatment from two clinical trials at the same time. She's a lung cancer specialist and also a head and neck cancer specialist, very active in trials. The drug development process will normally proceed through all four phases over many years. CONTINUE READING Some people think of clinical trials as a last resort. And so I think it makes them feel really good that people have these connections. Now, Pat, what do you think are some of the myths? I think the other important thing to know is the criteria we talked about is you can't—if you are truly getting a second opinion, you should get it before you start something, because you don't want to have started a treatment that you get one dose of something that blocks you from access to a clinical trial. What Does CAR-NK Cell Research Mean for All Cancers. This came in from George, who also has CLL. Researchers still use human volunteers to test these methods, and the same rules apply. Carey Anders, MD, is a medical oncologist with UNC Cancer Care. 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. “For me personally, it has been extremely rewarding to offer patients this option,” says Dr. Olajide. And so I mentioned I have chronic lymphocytic leukemia. Clinical trials are studies to test new drugs, already approved drugs, devices, or other forms of treatments. What would you say to them? Dr. Aggarwal, you have a lot of research going. 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. Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They're the reason why you and I are alive today. It was life-saving for him, and that is Pat Gavin. You know, some people sign up for Medicaid or Medicare replacement policies in the different states. For example, medical appointments could take a lot of time. 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. Thanks to our wonderful partner, the Patient Empowerment Network, and also the Coalition for Clinical Trial Awareness and the Alliance for Patient Access. She joins us from Penn Medicine, the Abramson Cancer Center in Philadelphia. And I think that's key in clinical trial participation, to get drugs to patients early. But Dr. Olajide says she would like patients “to be thinking about clinical trial options at the outset” of their cancer treatment. As a first step, let’s get a sense of how successful drug developers are with clinical trials by taking a look at some estimates of clinical trial success rates. Medical Oncologist, Medical Director of UNC Breast Care Center in Chapel Hill, UNC Cancer Care, UNC Breast Center in Chapel Hill. And emerging as the last resort for a miniscule number, particularly those in the educated and tech-savvy category, are clinical trials. You know, we have patients who travel across the country that might have a genomic mutation. That’s how you’ll get care that’s most appropriate for you. How to stay safe if you have cancer during the pandemic. She's wondering about since the drugs get combined but sort of one after the other, can you sort of start, and how does that work? Do you believe it made a big difference for you? And then I have another condition, scarring in the bone marrow, myelofibrosis, and I was very grateful that a new drug had been approved for that. Who should join clinical trials: Any time you or a loved one is diagnosed with cancer you should also look at clinical trial alternatives. And we've certainly seen that for lung cancer, but we've also seen that for head and neck cancer, and immunotherapy is now possible because of clinical trial participation. Now, in some cases a clinical trial may be a last resort, but in other cases, like you mention, there may be things about early treatment that would disallow you from participating in a clinical trial later on, so it's best to be talking about clinical trials as an option right from the beginning. You know, you meet people all the time. When you take part in a clinical trial, you add to our knowledge about cancer and help improve cancer care for future patients. Clinical trials involve testing new therapies or procedures to find new treatments for diseases such as cancer. Read and share this infographic to learn more about how clinical research might be right for you. Dr. Charu Aggarwal from Penn Medicine, the Abramson Cancer Center in Philadelphia, thank you for being with us again on one of our programs. Okay. 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