Tag Archive for: clinical trial participation
What Are the Benefits of Thyroid Cancer Clinical Trial Participation?
What Are the Benefits of Thyroid Cancer Clinical Trial Participation? from Patient Empowerment Network on Vimeo.
What are the benefits of thyroid cancer clinical trial participation? Dr. Lori Wirth discusses how clinical trials provide access to promising new treatments, offering patients additional options, and the potential for significant advancements in managing their disease.
Dr. Lori Wirth is the Medical Director of the Center for Head and Neck Cancers at Massachusetts General Hospital. Learn more about Dr. Wirth.
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Transcript:
Katherine:
Dr. Wirth, what would you say to patients who are hesitant to participate in a clinical trial?
Dr. Wirth:
Oh, boy. So, that’s such an important question.
Katherine:
Yeah.
Dr. Wirth:
And I think that the natural reluctance to put oneself into an uncertain setting like a clinical trial is completely understandable.
But a couple of things that I would say is first of all there is a lot of really deep work that goes into identifying new agents that have promise in the preclinical setting from laboratories either within the pharmaceutical industry or within academics. The amount of smarts that goes into development new drugs as well as early testing to ensure safety and that there’s a real signal of activity, that amount of work that’s done before a clinical trial is launched is really quite significant. So, when we’re bringing a new drug into clinical trials, we already know that there’s a very good likelihood that that drug is going to have good activity.
Katherine:
Okay.
Dr. Wirth:
The other reason for patients to think about participating in clinical trials is when patients have metastatic disease in the solid tumor setting whether it’s colorectal cancer or breast cancer, unfortunately most of our treatments don’t work so well that there’s a chance of cure. However, if we can’t cure a cancer, the next best thing is to knock it back and hold it at bay for as long as possible so that people can feel well but also live as long as possible.
However, if we don’t have a drug that can work so well that can cure cancer completely many cancers ultimately are going to escape the control, and we’re going to need new therapies for those patients. When patients participate in a clinical trial that’s just giving them a whole other treatment option. And so, to have more options available gives more chances that there’s going to be a real homerun or a real success in terms of treatment.
So, I would much rather have my patient have three options of treatment rather than two options of treatment. And we can always turn to the drugs that we have that are already FDA approved as long as somebody’s well enough to receive cancer treatment. If there’s a promising clinical trial of a new agent that’s only available in a clinical trial, and if we use that earlier in the course of the disease, that gives us more options for down the road.
What AML Clinical Trial Inequities Do Minority and Ethnic Groups Face?
What AML Clinical Trial Inequities Do Minority and Ethnic Groups Face? from Patient Empowerment Network on Vimeo.
Do minority and ethnic groups face acute myeloid leukemia (AML) clinical trial inequities? Expert Dr. Andrew Hantel from Dana-Farber Cancer Institute and Harvard Medical School discusses research study results of NCI-designated cancer centers of AML versus other cancers and proactive patient advice for clinical trial access.
[ACT]IVATION TIP
“…patients to ask about where the nearest sites of care are for them that have clinical trials on at least historically, and then reaching out to those sites to ask, ‘Can I have a consultation?” Am I somebody who might be eligible for any of the clinical trials that you have?’”
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Transcript:
Lisa Hatfield:
Dr. Hantel, what primary findings are in your study regarding inequities and clinical trial participation among minoritized race and ethnic groups with cancer at the comprehensive cancer centers?
Dr. Andrew Hantel:
So we performed a couple of different studies on this, I think together, they’ve collectively found that there are significant disparities in clinical trial participation among minoritized racial and ethnic groups at comprehensive cancer centers. And just to take a step back and say, what are comprehensive cancer centers? They’re basically a designated center, and the designation is provided by the National Cancer Institute (NCI), and that basically says that this place is of such and such a level of quality in terms of their delivery of cancer care and their research that they perform, and so these are generally larger academic centers that have a lot of clinical trials, have a lot of experts across different cancer types, including AML. And those are the ones that we are wondering if people had equal or equitable access to, in other cancers compared to AML.
A lot of the disparities in clinical trial participation is really because these different minoritized groups have less access to these comprehensive cancer centers, so they could really never be considered for trials, because they’re just not seen at places where the trials are taking place. This is the case for a lot of common solid tumors, such as breast and colon cancer, where very, very large proportions of patients are seen in the community.
And this means that in leukemia, however, we found that participation disparities were not only due to access, but because the leukemia is less common because a lot of docs actually almost preemptively refer some of their patients to get seen, some of the disparity is kind of shifted, and it ends up becoming not as much an issue just of access but also of getting into the trial after they’re seen at the center.
And this can be because of a variety of things, there are reasons that we can go into in a second, but we kind of also want to make the statement in the context of it not being a one-size-fits-all answer. There are some cases where comprehensive cancer centers actually both allow great access and allow equitable enrollment on their trials, and there are other comprehensive cancer centers that have had…and continued to have issues with this.
So I also just want to make sure to make that distinction. But after somebody gets down to a center, you have the process of, is there a trial at the center that’s actually right for your specific type of leukemia and the stage of the disease, and if you’re up front or relapsed or all of these other nuances, and then you have the questions of, are you eligible, are you offered that trial, and then are you interested in partaking in that trial, and is it feasible for you to participate?
So there are all these other steps after that point of access, and in general, what we saw was that it was kind of these later steps that were as much more of an issue for equitable enrollment for leukemia as that first step of access. And so it’s slightly different from what we’ve seen in other cancers, and so the answers and the solutions for that are going to be different.
So my activation tip for this question would be for patients to ask about where the nearest sites of care are for them that have clinical trials on at least historically, and then reaching out to those sites to ask, “Can I have a consultation?” Am I somebody who might be eligible for any of the clinical trials that you have?” That might be something where it does take you to that site to actually get evaluated and see if there is anything available, but that would be the first step.
Considering a Myelofibrosis Clinical Trial? Questions You Should Ask
Considering a Myelofibrosis Clinical Trial? Questions You Should Ask from Patient Empowerment Network on Vimeo.
What questions should patients ask when considering a myelofibrosis clinical trial? Expert Dr. Gabriela Hobbs discusses how clinical trials may fit into a treatment plan and shares key questions to ask your healthcare team about participation.
Dr. Gabriela Hobbs is a hematology-oncology physician specializing in the care of patients with myeloproliferative neoplasms (MPN), chronic myeloid leukemia and leukemia. Dr. Hobbs serves as clinical director of the adult leukemia service at Massachusetts General Hospital. Learn more about Dr. Gaby Hobbs.
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Transcript:
Katherine:
So, where do clinical trials fit into a treatment plan?
Dr. Hobbs:
So, it really depends on what is available at the site where you’re seeking care. Clinical trials come in a variety of different flavors. So, there may be a clinical trial for patients that are newly diagnosed, that are about to start a JAK inhibitor, for example.
So, if you’re a patient that’s considering a JAK inhibitor to treat your spleen symptoms or your systemic symptoms, and there happens to be a clinical trial for adding on another medication, like the first JAK inhibitor you receive, well, that’s a great place to consider a clinical trial.
There may also be clinical trials in later lines. Let’s say you were treated only with a JAK inhibitor first, but the study that’s available at your center is adding another medication to the JAK inhibitor if the JAK inhibitor by itself didn’t quite do the trick.
There’s also other studies, for example, at the time of transplantation, for example, using the JAK inhibitors during transplant. So, really the clinical trials can be relevant at any time during treatment. In addition to clinical trials, testing new medications, there’s also other ways to participate in research throughout your time as a patient with your care team, which may include things like, for example, consenting to participate in a tissue bank.
You donate a sample of your blood or bone marrow that is then later on used for research. Or we may have studies investigating the symptoms a patient has throughout their disease or their experience living with their disease. So, there’s many different ways of participating in research and clinical trials, even if those don’t necessarily include trying a new medication.
Katherine:
What questions should patients be asking if they’re interested in learning more about clinical trials?
Dr. Hobbs:
Yeah, great question. So, the first is understanding, you know, what is the medication that you will be receiving? Are you going to be receiving a placebo? Is that an option? This means a sugar pill. That’s a common question that I get. How do you get assigned to different groups? So, in one trial, there may be a group that gets one dose, another group that gets another dose, et cetera. So, it’d be important to know how are you going to get assigned and what are the options potentially for you before you sign up.
After that, it’s important to know what phase the study is in. So, is this a first-in-human study where your doctor may not be able to tell you a whole lot about what’s expected in terms of side effects or safety or toxicity? Or is this a Phase III study where maybe the trial has been open for many years and there’s been many patients that have been enrolled in it already? Or maybe this is a drug that’s already been approved for another condition and we’re borrowing it for myelofibrosis, for example, and then your care team can tell you lots of information about the safety and toxicities, etc.
So, having a sense of where the drug is in its development, I think can be very helpful. Then there are some practical things that we sometimes do not spend enough time talking about.
So, I’m glad to have the space to talk about that here. Participating in a clinical trial takes time. And it’ll take more time as a patient to participate in a clinical trial than to receive regular care. You may have to go to the hospital where you’re being treated more frequently. If you’re somebody that receives virtual care where some of your visits are telehealth and some of them are in person, you need to be aware that you may have more visits that are in person because the clinical trial procedure requires that certain labs or tests be done in the facility, not anywhere else. Clinical trials by definition, unfortunately, sometimes have to be very inflexible in order to ensure that we collect data in a uniform way.
So, just being aware that it may take more time to participate is important. And along those lines, asking if the clinical trial will reimburse you for some of that time. So, for example, if you need to park in the expensive hospital parking more frequently, some trials will actually reimburse you for that. Or they may offer a hotel reimbursement if you need to travel from far away and spend a night there. So, don’t be afraid to ask those things because many times that’s built into the clinical trial.
So, that’s an important thing just practically to know. So, asking for a study calendar so you get a sense of how frequently you’ll need to be going to the doctor is really important. Also, then realizing that potentially you may have to go to see the doctor or the care team more frequently initially, but then after the first couple of months, if everything is going well, you’ll likely have the flexibility to go less often. So, all those questions are important to have in mind.
AML Clinical Trial Participation Disparities | Impact on Access, Outcomes, and Inclusion Strategies
AML Clinical Trial Participation Disparities | Impact on Access, Outcomes, and Inclusion Strategies from Patient Empowerment Network on Vimeo.
What are AML clinical trial disparities, outcomes, and solutions for inclusion? Expert Dr. Sara Taveras Alam from UTHealth Houston discusses patient factors that impact access, underrepresented patient groups, and patient advice for improving clinical trial access.
[ACT]IVATION Tip
“…inquire if there are clinical trials available at the institution where you’re being cared for, not all institutions do have clinical trials available, and that is okay, but you should be informed and given the opportunity to look into other facilities if clinical trials are available and have the ability to do so.”
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Transcript:
Lisa Hatfield:
Dr. Taveras, so this is kind of a three-part question regarding disparities in acute myeloid leukemia. So what are the disparities in clinical trial participation among AML patients, and how do these disparities affect access to innovative treatments and outcomes, and then kind of a third part to this question, how can efforts be made to increase diversity and inclusion and clinical trials for AML?
Dr. Sara Taveras Alam:
Thank you. This is a very important question. Unfortunately, disparities exist in the outcome of AML patients based on different factors, social-economic factors, racial factors, ethnicity, and unfortunately, it has been proven that in clinical trials, the non-Hispanic white population is the predominant population study, so unfortunately, our African Americans or Black patients and our Hispanic patients are underrepresented, and this may impact whether or not the treatments that are getting put, being studied and being utilized in AML patients are appropriate for these patients who were not included on the clinical trials.
I do see that there is an intentional effort to recruit patients from minority groups in institutions where trials are available; however, one caveat is that unfortunately, some of those underrepresented populations don’t necessarily have access to the institutions that are leading the clinical trials. I’m in Houston, and we actually have a county system here in Houston, where leukemia trials are available, and that is really a blessing, because it’s not something that is very common. So throughout my training, when I did go to a county hospital, I was able to see Hispanic patients and African American patients being given the opportunity to participate in clinical trials that may impact the long-term treatment of other patients and those treatments being studied in the population that was using them.
My activation tip for this question is to inquire if there are clinical trials available at the institution where you’re being cared for, not all institutions do have clinical trials available, and that is okay, but you should be informed and given the opportunity to look into other facilities if clinical trials are available and have the ability to do so.
How Can Myeloma HCPs Overcome Unforeseen Practice Related Barriers?
How Can Myeloma HCPs Overcome Unforeseen Practice Related Barriers? from Patient Empowerment Network on Vimeo.
What are some solutions to myeloma patient care barriers? Expert Dr. Craig Cole from Karmanos Cancer Institute discusses barriers and solutions he has encountered with his patients and how patient comfort levels with clinical trials have improved.
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Transcript:
Dr. Nicole Rochester:
Dr. Cole, I’m going to turn the conversation back to you. As a physician, I know that often, there are some barriers just as part of our everyday practice that can hinder our work. And so I’d love for you to speak to any unforeseen or outdated practice related barriers that you feel may hinder your work, and the work of your colleagues specifically as it relates to myeloma trials. And then if you could also share some potential solutions to those barriers.
Dr. Craig Cole:
Yes, super good question. I love this question. There are a lot that are out there that I…barriers that I hear providers talk about at other academic centers and in the community. One is that patients don’t want to go on clinical trials that they…and some of that is subconscious bias. Sometimes those are true, true bias. We know the FDA knows all the drug companies all, and I think every myeloma provider knows that there have been horrific disparities in the enrollment of patients in clinical trials based on race and age and ethnicity that the FDA looked at some of the data of trials that were going for FDA approval, and found that over the past 10 years, and that in those trials, that only 4 percent of the population of the trials were Black.
While in the United States, the number of Black myeloma patients is about 20 percent, over 20 percent of the myeloma population. So that’s a huge disparity. And what I hear is that while older patients and Black and Hispanic and Asian patients don’t want to go on clinical trials, and that’s not true. That’s been shown in multiple clinical trials that actually, the patients of different ethnicities and races actually are more likely to go on clinical trials than other racial groups. And so I think that it’s really important to keep that in mind that patients really…that really the ownership of getting a patient on a clinical trial is really on us to present the clinical trial option to them with every single conversation that we have.
Some of the other barriers to clinical trials is, and Ms. Gleason had mentioned this, what they do at through the Emory system is that, well, the nurses and the other staff in the cancer center aren’t aware of the clinical trials, that when a patient goes through the clinic, they talk to more than just the provider. They talk to the treatment nurses, they talk to the intake people, they talked to the MAs, they talked to the scheduling people.
And there was a study that was done a few years ago in looking at patients who were given consent forms and declined clinical trials. And they found that a lot of patients declined clinical trials, well, because they said that, well, their doctor didn’t want them on the trial. And when they looked further into that, they saw that, well, the doctor offered them a clinical trial, but when they discussed the clinical trial with a nurse practitioner, when they discussed that trial with a treatment nurse or the MA or any of the other staff, when they didn’t know about the clinical trial, that was considered well, if you don’t know about the clinical trial, it must not be good for me. And then they withdrew from the trial.
So just like what they do, what Ms. Gleason had said, we have an all-in approach. We make sure that the treatment nurses, the MAs, the intake people know what we’re doing, know about our clinical trials, because that’s the fun part about what we do. The fun part is when we say, look, my goodness, this four-drug therapy had a 100 percent response rate. That shouldn’t be left in the physician compartment. It really shouldn’t be left in the provider compartment. That excitement should be clinic-wide. And when you have that all-in approach where everybody’s involved, everyone’s excited about clinical trials, it produces a culture of clinical trials that everybody wants to be part of, and the patients then can jump on that bus and feel comfortable participating in the trial.
Dr. Nicole Rochester:
Wow. Thank you for elucidating that. Both the issue of the health disparities that we see in clinical trials and the need to diversify that clinical trial patient population, some of those biases that exist, as well as really lifting up this idea of creating a culture of clinical trials.I love the language that you use for that and the idea that everyone throughout the entire clinical encounter needs to be both aware of, and excited about the clinical trials that are underway.
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Small Cell Lung Cancer Clinical Trials and DeLLphi Study Update
Small Cell Lung Cancer Clinical Trials and DeLLphi Study Update from Patient Empowerment Network on Vimeo.
What value might small cell lung cancer (SCLC) clinical trial participation and the DeLLphi study offer patients? Expert Dr. Vinicius Ernani from the Mayo Clinic explains the significance of clinical trial participation and what is being studied in the DeLLphi trial for SCLC care.
[ACT]IVATION TIP
“…always ask your team about clinical trials. And again, I recommend patients, if it’s a reasonable clinical trial, I will always recommend my patients to be enrolled in it.”
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Advice for Small Cell Lung Cancer Patients Considering Clinical Trials |
Transcript:
Lisa Hatfield:
Dr. Ernani, can you speak to the importance of expression of DLL3, what it is and what it means for small cell lung cancer research, and why is clinical trial participation so important in small cell lung cancer? And what advice do you have for patients who are considering a clinical trial?
Dr. Vinicius Ernani:
Yeah, so DLL3 is a protein expressed on the cancer cell of the majority of those patients with small cell lung cancer. And that’s where, exactly where tarlatamab, which is, it’s the BiTE, the T-cell engager that I mentioned before, that’s one of the targets. So the tarlatamab, it binds to the DLL3 on the surface of the cancer cell, and also bind to the CD3 at the T cell, right?
So that activation, the tarlatamab does that bridge and that activation enhances or activates the T cells to go there and fight the cancer. What we’ve seen in DeLLphi study with the tarlatamab is that the responses are irrespective of the DLL3 expression. But that being said, again, is the target of tarlatamab. And so it, again, it binds to the DLL3 the cancer cell, and it binds to the CD3 on the T cell.
And that activation enhances the T cell to fight against the cancer. Why is clinical trial participation so important in small cell? Well, I think I encourage all my patients to participate in clinical trials because some of the treatments that you can only get in clinical trials today, they might become the standard of care tomorrow.
Let’s say patients on immunotherapy five years ago, there are still some patients that are on trial, they’re still getting immunotherapy. And now, basically every disease you can treat the patients with immunotherapy. So you never know. The trial that you are enrolled in today might be the new standard of care tomorrow, and you might be having this chance to get it very early in the course of your disease.
So my activation tip for this question is, always ask your team about clinical trials. And again, I recommend patients, if it’s a reasonable clinical trial, I will always recommend my patients to be enrolled in it.
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Advice for Small Cell Lung Cancer Patients Considering Clinical Trials
Advice for Small Cell Lung Cancer Patients Considering Clinical Trials from Patient Empowerment Network on Vimeo.
What’s vital for small cell lung cancer (SCLC) patients to know about clinical trials? Dr. Rafael Santana-Davila with the University of Washington School of Medicine explains the impact of clinical trial on treatment advancements and questions for patients to ask when considering clinical trial participation.
[ACT]IVATION TIP
“…if you’re considering a clinical trial, to make sure you read that consent. And that consent can be difficult sometimes. So if you have questions, just ask. When patients are on clinical trials, there’s a whole team of people that are looking for that patient. So ask the questions that you may have from that consent with that patient.”
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Transcript:
Lisa Hatfield:
Why is clinical trial participation so important in small cell lung cancer? And what advice do you have for patients considering one?
Rafael Santana-Davila:
So clinical trials are very important, not only in small cell lung cancer, but in all cancers. The only way that we know how to treat this is by doing clinical trials. That is what moves the needle forward. It’s thanks to patients that participate in clinical trials that we know whether something worked or how much worked or something did not work, and we need to either get back to the drawing board or eliminate that possibility and move on.
Unfortunately, only the minority of patients participate in clinical trials and that is many times only because of access. So it’s important for patients to consider clinical trials. That is where we’re analyzing the future medications, and many of those future medications will become the standard of care and by participating in clinical trials, patients will have access to those medications.
And by participating in clinical trials, patients are also paying it forward. These clinical trials may not help them as much as possible, but they are helping those patients down the line. When patients are considering a clinical trial, there’s many questions that they need to ask is, “What does that involve for me? How frequently do I need to come to the cancer center? Aside from getting it, what else is asked from me? Am I being asked to also come to other blood draws, for example, or am I just receiving this treatment and that’s treatment by itself? Is there a randomized component to this clinical trial? Am I being elected to receive one arm or the other? Is there a placebo component in that trial?” The majority of patients with the majority of trials in cancer are not placebo-based.
But that’s important to know. “What help can the clinical trial give me?” Again, like we talked about, many clinical trials can help patients with lodging or transportation. So the activation tip for that is, if you’re considering a clinical trial, to make sure you read that consent. And that consent can be difficult sometimes.
So if you have questions, just ask. When patients are on clinical trials, there’s a whole team of people that are looking for that patient. So ask the questions that you may have from that consent with that patient. And I always encourage a clinical trial because again, that is what is helping us move the needle forward.
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What Are the Potential Benefits of an Advanced Non-Melanoma Skin Cancer Clinical Trial?
What Are the Potential Benefits of an Advanced Non-Melanoma Skin Cancer Clinical Trial? from Patient Empowerment Network on Vimeo.
Clinical trials are an option for some advanced non-melanoma skin cancer patients, but what are the potential benefits? Dr. Diwakar Davar shares his perspective on why patients should consider trial participation.
Dr. Diwakar Davar is the Clinical Director of the Melanoma and Skin Cancer Program at UPMC Hillman Cancer Center. Learn more about Dr. Davar.
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Transcript:
Katherine:
Dr. Davar, thank you for that detailed information. It is really valuable. You mentioned, a few moments ago, clinical trials. What are the benefits of participating in a clinical trial?
Dr. Davar:
Well, the first and the most important benefit of participating in a clinical trial is that oftentimes, your team is larger. Normally, a patient has a doctor. We have a PA and we have a nurse taking care of them. When you have a clinical trial, at that clinical trial, you have three, four, five times that number of people taking care of you. There are research nurses, research coordinators, nurse navigators, and all of these people are looking over your chart helping the doctor cross-check and check to make sure that nothing falls through the cracks.
The first and the most important thing is when you enter a clinical trial, your team grows. You have a primary physician taking care of you, but he has more help and more support. That helps ensure that the best possible care is delivered for our patients. The second benefit of taking part in clinical trials is that you oftentimes have access to the latest and the greatest.
For example, in the context of non-melanoma skin cancer that is transplant associated, these provocative approaches that are being tested, immune augmentation of immune suppression with concurrent systemic immunotherapy without causing allograft rejection, this is only available in the context of an NCI, ECTCN funded trial that Dr. Lipson is leading. If you’re not a member of one of the ECTCN sites, you do not have access to this trial. If you’re not a patient that is being seen at one of these sites, you, unfortunately, do not have access to this trial.
The key thing here is, entering a clinical trial represents the ability, potentially, to get a treatment that potentially could improve cancer and save one’s life without causing allograft rejection. In the context of the RP1 study, you could potentially be getting a drug that doesn’t cause allograft rejection and causes cancer aggression in a significant number of patients, but again, it is not a standard of care agent.
Entering clinical trials helps you because it allows you access to the latest and the greatest in terms of treatment modalities, but also, it allows you to receive the best possible care.
Why Renal Medullary Carcinoma Clinical Trial Participation Is Pivotal
Why Renal Medullary Carcinoma Clinical Trial Participation Is Pivotal from Patient Empowerment Network on Vimeo.
What do renal medullary carcinoma (RMC) patients need to know about clinical trials? Expert Dr. Nizar Tannir explains the importance of clinical trial participation, what is examined in clinical trials, and advice for patients who are considering clinical trials.
Dr. Nizar Tannir is a Professor in the Department of Genitourinary Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.
[ACT]IVATION TIP
“…you should not be afraid of trials, you should embrace them and you should participate in them…the role of the physician is to explain the rationale and the potential benefits and potential toxicity, because everything has a price. Unfortunately, there are some drugs that could cause side effects, but hopefully it’ll be worthwhile to achieve to break the barrier of cure.”
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Transcript:
Cora:
Why is clinical trial participation so critical in RMC, and what advice do you have for RMC patients considering a clinical trial?
Dr. Tannir:
Clinical trials are important in oncology in general, and specifically in tumors that are rare and aggressive. For decades now, I would say for the past 20 plus years since the initial reports of RMC were made back in the mid ’90s, I will recognize that RMC was a cancer that affects individuals who have sickle cell trait, chemotherapy has been the mainstay, and it’s still a reliable and good treatment to start with. But we can’t stop with just chemotherapy, we can’t just have chemotherapy. We need more effective drugs, we need more drugs, because, unfortunately, not every single patient with RMC will respond to chemotherapy like Herman did and be cured and alive and are living well 10 years, 11 years and beyond.
Patients may respond to treatment and has often happened, unfortunately, the resistance sets in so the cancer cells become resistant to the chemotherapy that you gave to the patient. And then the disease will start progressing again. So you need to think about other therapy. So while we have more than one chemotherapy regimen we can treat our patients with, we still need to identify relevant targets for RMC that we can develop new therapies. And this is where clinical trials become important. And so my activation tip is for patients with RMC to consider participating in clinical trials with the hope that we will bring to FDA approval, newer drugs, and not just chemotherapy. I can mention to you, Cora, that with the first trial we launched in RMC was in 2015 with a drug called tazemetostat (Tazverik).
We opened this trial. We launched this trial with this drug, which was oral, in many rare tumor types and I lobbied, I worked hard with the Epizyme, the company at the time, which was subsequently bought up by another company to have a cohort of patients with RMC to treat them with this drug. And people were skeptical that I will be able to recruit and enroll any patient on this trial. And I said, “I know if we have this trial, patients will come.” As the saying goes, you build it and they’ll come. We opened the trial. Within six months, I had nine patients enrolled within six months. Whereas in the past, we used to see one, two patients per year. In six months, we had nine patients enrolled in the trial. The trial, we finally finished the trial.
Unfortunately, the drug did not provide durable benefit to patients, although we saw dramatic responses that were brief lasting only weeks, but there were dramatic responses. So, but we cannot achieve success without having to go through failures. We cannot be discouraged by negative trials, by negative results or disappointing results or results that are gratifying, but for a short period of time and then the cancer progresses. So my activation tip is for patients and their loved ones to support clinical trials that are well thought out that bring the opportunity to patients with RMC and other cancers, the opportunity to test some novel therapies based on grounded in biology.
You really have to do the research first. You really have to identify relevant targets, and you develop these therapies against those targets to really be able to say, you know I believe this will work and it may not work, but we have to try it. And so my activation tip is trials…you should not be afraid of trials, you should embrace them and you should participate in them. But, of course, you know the role of the physician is to explain the rationale and the potential benefits and potential toxicity, because everything has a price. Unfortunately, there are some drugs that could cause side effects, but hopefully it’ll be worthwhile to achieve to break the barrier of cure.
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How Advancements in Breast Cancer Are Driven by Clinical Trials
How Advancements in Breast Cancer Are Driven By Clinical Trials from Patient Empowerment Network on Vimeo.
Breast cancer clinical trials are a treatment option, but what do patients need to know? Expert Dr. Demetria Smith-Graziani explains the importance of clinical trial participation and shares advice for patients considering clinical trials.
Demetria Smith-Graziani, MD, MPH is an Assistant Professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine. Learn more about Dr. Smith-Graziani.
[ACT]IVATION TIP
“…ask your oncologist, ‘Are there any clinical trials that’d be a good fit for me?’ And if they mention some trials, I would ask for a copy of the consent form to read over it, which they need to provide to you anyway, and take so time to read over it on your own and ask any questions that come up so that you completely understand what the clinical trial involves, if there are any cost to the trial, how much time you would have to spend in the clinic or in a hospital getting this special treatment under the trial, and any other concerns that you might have about the trial.”
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Transcript:
Lisa Hatfield:
Why is clinical trial participation so important in breast cancer? And what advice do you have for patients considering a clinical trial?
Dr. Demetria Smith-Graziani:
So clinical trials are vitally important to advancements in breast cancer treatments, all of the current treatments we have that are FDA-approved were approved because of the results from clinical trials that previous patients participated in.
And we won’t get any new advancements in breast cancer treatments and come up with even better, more effective treatments, unless we are able to do more clinical trials with more patients. The other part is that in the past, most of the participants of clinical trials have been pretty much the same, they have been mostly white, mostly have insurance, mostly of a higher socioeconomic status, and those patterns continue today, we are still trying to get the patients in clinical trials to reflect the true population of the United States. And in order to know that clinical trials are effective for everybody, we need to have everybody in those trials. So for patients who are considering a clinical trial, my activation tip is to ask your oncologist, “Are there any clinical trials that’d be a good fit for me?” And if they mention some trials, I would ask for a copy of the consent form to read over it, which they need to provide to you anyway, and take so time to read over it on your own and ask any questions that come up so that you completely understand what the clinical trial involves, if there are any cost to the trial, how much time you would have to spend in the clinic or in a hospital getting this special treatment under the trial, and any other concerns that you might have about the trial.
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What Endometrial Cancer Patients Should Know About Clinical Trials
What Endometrial Cancer Patients Should Know About Clinical Trials from Patient Empowerment Network on Vimeo.
What do endometrial cancer patients need to know about clinical trials? Expert Dr. Ebony Hoskins explains the importance of clinical trial participation for all patients and shares advice for patients to improve their clinical trial access.
Dr. Ebony Hoskins is a board-certified gynecologic oncologist at MedStar Washington Hospital Center and assistant professor of Clinical Obstetrics and Gynecology at Georgetown University Medical Center.
[ACT]IVATION TIP
“…asking their provider, one, are clinicals trial offered at their institution. And second, if it’s not offered at the institution, do you think that, are there any other institutions that may offer trials for the patient?”
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Transcript:
Mikki:
Dr. Hoskins, why is clinical trial participation so important in endometrial cancer? What advice do you have for patients considering a clinical trial?
Dr. Ebony Hoskins:
So I think clinical trial participation is important in endometrial cancer. Number one, the rate of Black women getting advanced and aggressive endometrial cancer is on the rise. The representation in these trials are different. What’s different is not only the patient, the tumor type is different. How do we know that these same patients that’s not in the trials are going to respond to this treatment? That’s what I always ask. I’m like, maybe they don’t respond as well, because that’s a different disease type, right?
So we recently looked at a trial where most of the patients had an endometrioid type of endometrial cancer, whereas I, in my practice, I see a lot of Black women who don’t have endometrioid type. They may have a serous type, which is a more aggressive type or a carcinosarcoma. So I don’t know if I can really apply that to this, to that the medication.
That’s all I have, but how do I know that she’s going to respond in the same way? So I think it’s definitely important. I recently had a patient that I referred to a clinical trial. And she really was struggling with whether she should do it or not. And one of the things that I said to her is, “I think it’s important. One, you’re going to have access to advanced treatment options that are not there now.” And I said, also I said, “Not that she has to take it for a whole group, but we need to have more information on the type of cancer you have.” And I was like, “And Black women are dying, and we need this information to know if this is the same.” And she instantly was like, “I’m going, I’m doing it.” And I mean, not that she has to take, but we need to know more. And I think it’s very important that we have patients with access to trials.
Mikki:
Yes. Do you have an activation tip for those patients that you see?
Dr. Ebony Hoskins:
I think asking their provider, one, are clinical trials offered at their institution. And second, if it’s not offered at the institution, do you think that, are there any other institutions that may offer trials for the patient? There are sometimes where patients don’t have the opportunity to travel elsewhere and need to be in their community for work, family, etcetera. So I understand the asking.
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Ovarian Cancer and Clinical Trial Participation: What Patients Should Know
Ovarian Cancer and Clinical Trial Participation: What Patients Should Know from Patient Empowerment Network on Vimeo.
What do ovarian cancer patients need to know about clinical trial participation? Expert Dr. Ebony Hoskins explains the importance of clinical trial participation and key advice for patients who are considering participation in a clinical trial.
Dr. Hoskins is a board-certified gynecologic oncologist at MedStar Washington Hospital Center and assistant professor of Clinical Obstetrics and Gynecology at Georgetown University Medical Center. Hoskins sees women for gynecological malignancies, which include the treatment of endometrial, ovarian, vulva, vaginal and cervical cancers.
[ACT]IVATION TIP
“…inquire with your doctor, ‘Am I a candidate for a clinical trial? Do you offer a clinical trial, are there clinical trials that would fit my scenario that’s local that I could go to? Are there clinical trials that are available, say, out of state that you think I will be a good fit for?’”
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Transcript:
Mikki:
Dr. Hoskins, why is clinical trial participation so important in ovarian cancer, and what advice do you have for patients considering a clinical trial?
Dr. Ebony Hoskins:
One, I always tell patients is the reason we know what to give you now, treatment is based off a clinical trial. So we need these trials. We didn’t just create a new drug and just gave it. We need to know, is it going to improve survival? What are the side effects? Is it going to kill the cancer? And so it’s important to be on the cutting edge if you will, of advancement in the field. The only way I know what to give patients is based off a clinical trial.
Right, so that’s number one. The advice for patients I have is, I think understanding what the options are for treatment, whether they come off of trial. So knowing if I’m not on trial, what am I going to get? If I am on trial, what am I going to get? What are the side effects? Side effects is an important thing. What are the safety issues? Because not only are there side effects, there can be a safety issue. I think one thing that we don’t really talk about that could be there, is some of the clinical trials depends on who’s sponsoring it, provide the drugs, and some of the drugs are quite costly, so that’s something that we’re not talking about.
The financial toxicity and sometimes coming under their trial, the drugs are covered, so you’re getting cutting-edge care that comes as maybe it’s not as costly to you, so I think, again, my activation tip for a patient is inquire with your doctor, “Am I a candidate for a clinical trial? Do you offer a clinical trial, are there clinical trials that would fit my scenario that’s local that I could go to? Are there clinical trials that are available, say, out of state that you think I will be a good fit for?” And sometimes…again, not every patient is a clinical trial candidate for a number of reasons, but asking the question, I think is huge.
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Why Is Clinical Trial Participation Vital for Diffuse Large B-Cell Lymphoma Patients?
Why Is Clinical Trial Participation Vital for Diffuse Large B-Cell Lymphoma Patients? from Patient Empowerment Network on Vimeo.
Why is it vital for diffuse large B-cell lymphoma (DLBCL) patients to participate in clinical trials? Expert Dr. Nirav Shah from the Medical College of Wisconsin shares his perspective on the benefits of clinical trial participation and advice for patients who are considering joining a trial.
Dr. Nirav Shah is an Associate Professor at the Medical College of Wisconsin. Learn more about Dr. Shah.
[ACT]IVATION TIP:
“…for clinical trials is, consider them. They may not be right for you, and that’s okay.”
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Transcript:
Lisa Hatfield:
Okay, Dr. Shah, why is clinical trial participation so important with DLBCL patients, and what advice do you have for those patients considering a clinical trial?
Dr. Nirav N. Shah:
Yeah, so number one, I always tell my patients one thing is it’s, clinical trials are an opportunity or an option, not a mandate. And so I never want a patient thinking that they have to participate in the clinical trial, participating in a clinical trial is an opportunity to help define potentially, the next treatment. Every treatment we’ve talked about up until this point was because kind, courageous people were willing to participate in a clinical trial. We wouldn’t have CAR T if hundreds of patients didn’t go on these clinical trials and be willing to be a subject and go through a treatment that was at the time undefined and without knowing how efficacious it was going to be.
And so clinical trials are important because without patients participating in clinical trials, how can we do better? That being said, a clinical trial is not right for every patient, and so it’s a value, it’s a judgment that each individual has to make. But I know that I really value my patients that are willing to participate because they all become part of that story about how to improve outcomes for diffuse large B-cell lymphoma for that patient who’s diagnosed five years from today or 10 years from today. And their participation, again, may not be recognized in the time that they’re participating, but what they did helps define the future of how we treat this disease. So my activation point for clinical trials is, consider them. They may not be right for you, and that’s okay.
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Prostate Cancer Clinical Trial Safety and Protocols
Prostate Cancer Clinical Trial Safety and Protocols from Patient Empowerment Network on Vimeo.
Expert Dr. Sumit Subudhi explains clinical trial safety protocols, the risks of participation, and addresses the patient concern of clinical trials as a last-resort treatment option.
Dr. Sumit Subudhi is an Associate Professor in the Department of Genitourinary Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. Learn more about Dr. Subudhi.
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Transcript:
Katherine:
Patients also often have questions about safety. So, what are the risks of clinical trial participation?
Dr. Subudhi:
So, safety is a major issue, especially more into the Phase I. The Phase I trial, if you remember, are the trials where we’re dose escalating, meaning we start off with a small cohort of patients, maybe three to five patients. And we give one dose of the drug. We see if it’s safe. If it’s safe, then we go to the next dosing level. And we just keep going until we find a dose that may be too toxic or too unsafe for our patient.
So, in the Phase I, we have less information, especially in the first-in-human drugs. But in those cases, we are watching you carefully to make sure that nothing bad happens to you.
But the problem with those trials is it requires a lot of time at the institution or with your doctor. For example, I’m doing a bispecific trial where we have to keep the patients inside the hospital for eight days, purely for safety reasons. They’re not getting the drug for all eight days. But we’re just keeping them under observation so in case anything bad happens we’re ready to react because we know that if something bad happens at their home in that first eight days, it could actually risk their lives.
So, in those cases, some trials, if we’re concerned about safety, you’ll be spending more time in the doctor’s office or in a hospital being evaluated. So, that’s the one negative. But sometimes, the trials that can be more exhausting as far as the amount of time it takes you away from your home and family are the ones that have the most reward.
Katherine:
Well, then it’s a tossup, isn’t it?
Dr. Subudhi:
That’s right.
Katherine:
You have to decide what’s more important.
Dr. Subudhi:
That’s correct.
Katherine:
Well, what protocols are in place to protect patients?
Dr. Subudhi:
So, when they sign up for a protocol, we are instructed to give them our best information. So, let’s say it’s a first-in-human drug. Well, usually, first-in-human drugs are tested in other mammals, such as monkeys, and we look for toxicities there. And we have signs of what’s going to happen. Sometimes, a first-in-human drug is part of a class of drugs, like I talked to you about T-cell bispecifics.
Well, there’s several T-cell bispecifics out there. And we’ve learned that this class of drugs has a unique set of side effects that they all tend to have. Some have it more, and some have it less.
But when we’re discussing this with you or the patient, we are actually going to go through each and all of these side effects. Now, me personally, my patients that go on my trials, they all get my cellphone number so they have 24/7 access to me because I know they’re taking a risk. And it’s a lot of courage to go on these trials. And it’s scary. And I want to make sure they don’t feel like they’re ever alone.
Katherine:
Another common concern we hear is that a clinical trial is only considered when there are no other treatment options available for a patient. What are your thoughts on this?
Dr. Subudhi:
There’s a lot of my colleagues in the field that feel that way. And I know a lot of patients’ misconceptions are also that way. And that’s partly because of Hollywood and movies and TV shows that we watch. But I think that many people, especially in the medical field, think of clinical trials as the last resort.
And I actually disagree with that. I think that I like to actually start my patients with one or two standard of care treatments. But after that, really start putting clinical trials in between. And we have to remember that there’s not always a clinical trial available that the patient actually meets the criteria for.
So, it’s always disheartening in clinic when I meet someone for the very first time who was referred to me because they exhausted everything. And we just don’t have any clinical trials available, or they’re so weak from the cancer and all the prior treatments that they don’t qualify for a clinical trial. And then I really don’t have anything else to give them.
So, my personal approach is to try to put clinical trials in between and always have something in my back pocket so that if they get a bit exhausted or they want to spend more time with friends and family, they can get the standard of care treatment.
