Tag Archive for: clinical trial access

What Endometrial Cancer Patients Should Know About Clinical Trials

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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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Accessing Myeloma CAR T-Cell Therapy Clinical Trials

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Accessing Myeloma CAR T-Cell Therapy Clinical Trials from Patient Empowerment Network on Vimeo.

How has CAR T-cell therapy changed the landscape of myeloma care? Dr. Brandon Blue shares how this therapy has been a “game changer” in myeloma care, and how clinical trials for newer CAR T-cell therapies are advancing care and access for patients.

Dr. Brandon Blue is Assistant Member and Clinical Instructor in the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, FL. Learn more about Dr. Brandon Blue.

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Transcript:

Katherine Banwell:

Dr. Blue, we know that the approved CAR T-cell therapies are for patients who have already undergone several lines of treatment. How has this therapy revolutionized care for myeloma patients?  

Dr. Brandon Blue:

Yeah. So, CAR T is really a game changer when it comes to multiple myeloma. I’ll tell you that previously people have seen a lot of the best medicines that we have, and unfortunately for a good percentage of people the disease just becomes what we call refractory.  

And unfortunately, despite us giving them the best medicines, the disease still likes to survive. So, we had to think of something of what can still kill cancer, but may not be the traditional chemotherapy that people may think of? So, we say, “Well, let’s come up with CAR T because it’s a way to actually use the body’s own immune system to fight off those cancer cells.” And for myeloma it really has shown a lot of progress. And one of the things that we know now is that not only do we have one, but we have two products, and maybe even a third coming down the pipeline because there’s more and more of this CAR T becoming available. 

And that’s better, and better for patients.  

Katherine Banwell:

Absolutely. That’s great news. For patients who are recently diagnosed, Dr. Blue, is there any chance of accessing this treatment sooner? Maybe through clinical trials. 

Dr. Brandon Blue:

Yeah. One of the biggest clinical trials that I think that people are excited about is trying to challenge something that we’ve been doing since the 1980s, which is stem cell transplant.  

So, typically, when a person get diagnosed with multiple myeloma, especially newly diagnosed, stem cell transplant is typically part of the treatment plan. But now there’s clinical trials that are coming out where we challenge instead of maybe a patient going to stem cell transplant, maybe they might do CAR T instead. And we’re trying to figure out can something that we’ve been doing since the ‘80s be un-throned as the best standard practice? And so, I think that’s something that people are really excited about, that’s something I’m excited about. 

And it gives people who are newly diagnosed a chance to get some of this novel therapy.   

Katherine Banwell:

I have a follow-up question about the clinical trials, you mentioned that there is one going on. Where is it taking place?  

Dr. Brandon Blue:

Yeah. So, it’s actually a multi-center study. And so, hopefully, we hope to have Moffit Cancer Center involved in that clinical trial, but it’s multiple different sites really all over the world because I think this is a question that everybody’s really excited about. Again, like I said, transplant has been happening since 1980s, and so for some treatment to come along to potentially challenge that, I think people are excited about a new contender. And we’ve already seen the progress that CAR T has already made. 

And so, the big question is how well will it work when someone is newly diagnosed before their body has really seen all the extra treatments that are there? Will it work even better?  

We’re very hopeful, and we’re very optimistic. 

Katherine Banwell:

Where can people find out about this particular clinical trial and other clinical trials?  

Dr. Brandon Blue:

Yeah. So, I tell people there’s so many different websites and resources. One of the main ones that is very readily accessible is clinicaltrials.gov, is very kind of easy, and intuitive. Typically, what you can do at clinicaltrials.gov is you can literally kind of just type in your disease process, and then they’ll tell you if it’s newly diagnosed, or relapsed. There’s also a place called SparkCures. SparkCures is fantastic organization that really tries to focus people, and get them matched with clinical trials, which is fantastic.  

There’s also HealthTree. HealthTree not only helps people from a clinical trial standpoint, but they also have patient support programs because nobody wants to be in the fight for cancer by themselves. The American Cancer Society does a fantastic job, as well as Leukemia & Lymphoma Society. 

The International Myeloma Foundation, or the IMF, and then the MMRF, the Multiple Myeloma Research Foundation. And there’s many more, but those are some of the top ones that we readily use that have a lot of information. And some of them have not only information for the patient, but also information for the family, and the caregivers. Because again, when someone gets diagnosed with cancer it doesn’t just affect the person, it affects the whole family.  

Health Equity: Accessing Quality MPN Care and Clinical Trials

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Health Equity: Accessing Quality MPN Care and Clinical Trials from Patient Empowerment Network on Vimeo.

How can health equity be addressed in MPN care? Dr. Angela Fleischman discusses the importance of clinical trial diversity and ways to help provide equitable MPN care for all patients.

Dr. Angela Fleischman is a physician scientist and assistant professor in the Department of Medicine at the University of California, Irvine. Learn more about Dr. Fleischman.

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Transcript:

Katherine:

Based on American history, some people believe that they won’t receive equitable or safe care if they participate in a trial.  

How can you reassure those people who are concerned they’ll be treated fairly? 

Dr. Fleischman:

Now, I think that this is a very important point, and something that there’s been a lot of emphasis, to try to improve diversity in clinical trials, because our American population is quite diverse. However, the participants that, in general, participate in clinical trials are, unfortunately, still have not a very diverse population in our clinical trials. 

I think what we need to first start doing is education, to reach out to underrepresented communities, to start to build the trust amongst these communities, to tell them about the value of clinical trials. And I think it’s going to take some time to build trust first, because it does take quite a bit of trust to participate in the clinical trial. 

But I don’t have a great answer for that, other than, we need to work hard to, first, build trust, and then, I think the diversity will come. 

Katherine:

Mm-hmm. How does holding on to some of these beliefs lead to limitations in care and create disparities? 

Dr. Fleischman:

So, and rightfully so, if a patient is scared, or has some reservations of participating in a clinical trial, they may – that’s offered to them, that they provide them with, potentially, something better than standard of care. They may be missing out on a potential opportunity. 

Also, potentially, if a patient, if they’re asked about a clinical trial and they have a negative connotation about them, they may lose trust with their physician, if they say, oh, my physician is asking me to participate in a clinical trial.  

I think it all boils down to trust, and as physicians, we need to demonstrate that we are worthy of the patient’s trust, and we really are ingrained in us to treat every patient the same. I mean, that’s what our oath is. That’s what we’re supposed to do, and I think that the vast majority of patients, they have, ethically, are treating patients exactly the same, regardless of their circumstances.  

Katherine:

Health equity means that no matter what a patient’s circumstances, whether it be race, income issues, lack of education, that they should have access to the best care. What is being done by the medical community to address this issue?  

Dr. Fleischman:

So, yes, this is a significant issue, and in particular, with myeloproliferative neoplasms, in whom there are lots of oral drugs – or with interferons, it’s injectable, but you get the prescription, and you give it to yourself – that there can be quite high copays, in some cases, exorbitant amounts, which, really, are not able to be paid for by the vast majority of people. 

So, many companies do have copay assistance programs. Also, foundations have copay assistance programs. So, I think that is, at least, one step in trying to make things more equitable, to get people who need a drug, their drug, at a very reasonable cost. Again, it does take some time, some legwork on the part of the patient, to seek out these programs, or to find an advocate for themselves to seek out these programs for them.  

What Barriers Do CLL Patients Face in Accessing Clinical Trials?

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What Barriers Do CLL Patients Face in Accessing Clinical Trials? from Patient Empowerment Network on Vimeo.

When could CLL patients run into barriers to clinical trial access? CLL expert Dr. Adam Kittai explains how access can vary, explains cooperative groups, and discusses the financial benefits of some clinical trials.

Dr. Adam Kittai is a hematologist and an assistant professor at the The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Kittai, here.

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Transcript:

Katherine:

What do you feel are the barriers to accessing clinical trials for patients?  

Dr. Kittai:

So, unfortunately, a lot of clinical trials are at academic centers, and so there are – and the reason that is, is that the academic centers have the infrastructure to run the clinical trial. So, as we have mentioned before, there’s a lot of visits with a lot of extra science and labs that are done associated with the clinical trial. And a lot of those things and the coordination can only be done at large centers that can open clinical trials and know how to run them.  

Similar explanation could be that that safety monitoring committee that I’d mentioned before, where the academic centers have the infrastructure to ensure safety for the patients. So, access to academic centers is a limitation to enrolling in clinical trials. That being said, there are a lot of centers that are associated with an academic center and do have a lot of the clinical trials that are available at the academic center.  

And there are also cooperative groups. These cooperative groups are called Alliance and ECOG and SWOG. And these cooperative groups are national groups that are headed by multiple academic centers in partnership with pharmaceutical companies and they typically run large Phase III medical trials that help redefine standard of care. And those particular clinical trials are often available at private practices as well.  

Katherine:

Oh, that’s great. So, patients don’t necessarily have to think about traveling to a large educational institution then to become part of the clinical trial?  

Dr. Kittai:

Not always. Not always. Typically for the Phase I, the answer is yes. But for Phase III trials, usually there’s a lot of access available for Phase III trials.  

Katherine:

What would you say to patients who may be hesitant about participating in a trial?  

Dr. Kittai:

I would say that it’s important to at least ask about what’s available. And knowing what’s available and the risks and benefits of going on a clinical trial is how you should make the determination if you should go on a clinical trial.  

Remember what I said earlier that the clinical trial is really meant to help improve safety or efficacy. So, we don’t open clinical trials that we are not hoping to improve one of those two things. And so, that is something that we should be able to put in words to you when inquiring about the clinical trial. What is the goal of this trial, and why do you think it’s going to improve safety or efficacy? And the physician who’s talking the trial with you about it should be able to answer those questions for you. So, if you have some hesitance about going in clinical trials, I would say gather your information first before making a final decision.  

Katherine:

Some patients worry about the financial aspect or impact of a clinical trial. Aren’t trials expensive?  

Dr. Kittai:

So, actually, most clinical trials are less expensive than enrolling a standard of care. So, this is actually a benefit of going on a clinical trial. Often times, the drugs in the clinical trial are a cover. So, that’s something to ask too. And so, if somebody’s having trouble getting access to novel therapy that is looking good in a specific cancer, a clinical trial is actually a way to get access to that drug without paying for it.  

Also, all clinical trials when they’re being developed are looked at by the finance committees of the hospital or wherever it’s being developed. All standard of care options are billed through the patient insurance, but all the extra stuff is usually covered by the pharmaceutical company that’s enrolling those patients onto the trial. Or I should say the supporting the clinical trial.

How Can You Access an MPN Clinical Trial?

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How Can You Access an MPN Clinical Trial? from Patient Empowerment Network on Vimeo.

How can MPN patients access clinical trials? Dr. Ruben Mesa provides tips and resources for patients to learn more about participating in an MPN clinical trial.

Dr. Ruben Mesa is an international expert in the research and care of patients with myeloproliferative neoplasms (MPNs). He serves as executive director of UT Health San Antonio MD Anderson Cancer Center in San Antonio, Texas. More about this expert, here.

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Transcript:

Katherine:                  

Dr. Mesa, let’s move on to participation. How can someone find out about what trials are available to them?

Dr. Mesa:                   

So, first and foremost, it begins with a conversation with your physician. And overall, clinical trials – the majority of clinical trials are in situations where things are not going perfectly. You know, if you’re doing well, you’re feeling well, you’re doctors a hundred percent happy with how you’re doing, then a clinical trial may or may not be an option. They are usually in a situation where things are not going as well as we would like. You have residual symptoms; you’ve only had a partial response.

If the current medicines for the disease don’t agree with you, you had side effects, or others. Now additional research for learning about these trials include many different organizations. There are disease-specific ones, like the MPN Research Foundation, MPN advocacy & Education International, MPN Hub, amongst many others. There is the broader, clinicaltrials.gov. Now, that’s a very broad site.

It is searchable. Sometimes it gives you more information than is helpful, but most things are listed on there. The Leukemia and Lymphoma Society, at LLS.org, has a specific kind of navigation function that they have for learning more about clinical trials and getting matched up with them.

But it truly starts with you and your doctor. If things aren’t working well, what are the options that I have? Is it a different option in terms of therapy? Or, if not, asking about clinical trials because clinical trials, again, will have their own upsides and downsides you and doctor will go through depending upon your situation.

Katherine:                  

What are the barriers to accessing clinical trials? Are there any?

Dr. Mesa:                   

So, first, clinical trials have, kind of, the broader logistics barriers. Frequently, you need to enroll and participate at a particular site and sometimes that site is not locally. Your doctor may or may not be participating in that trial. Some trials are only done at a single institution. So, for many, there can be a hassle factor.

You know, it’s impractical for me to be there, or be there for the frequency of visits or other pieces. So, that is one potential barrier. Overall, we hope that insurance or other coverage is not a barrier. In general, clinical trials are structured in a way to hopefully have them be financially neutral for patients.

It’s not less expensive to get your care if you’re on a trial, but it shouldn’t be any more expensive because the standard of care items are billed to your insurance as they would be normally. But if there are things that are experimental, they are included as an expense of running the trial and you’re not charged for those. Now the other barrier is, specifically, trials tend to have a specific set of eligibility for participation that are medical. It may be in a subset of patients based on any number of factors.

And there may be other limiters in terms of prior health conditions, sometimes in terms of age, sometimes in terms of how well the heart, the liver, the kidneys, or other things work. There’s both kind of a logistical piece, but then there is very specific eligibility. As a researcher, when a patient is a candidate for a clinical trial, I will have to go point by point, and sometimes there might be 50 points of disease, blood tests, and organ function – other pieces that need to be correct for participation in that trial.

It’s not to say that drug may not conceivably help that individual. It’s to say that for that specific trial, that’s what’s needed to participate in that very specific clinical trial.

So, sometimes that can lead to a bit of frustration, but it’s critical so that that trial is comparing the right group of patients so that the safety is really as great as the safety can be in the conduct of that study.

Katherine:                  

Right. What sort of questions should patients be asking their healthcare team about participating in a clinical trial?

Dr. Mesa:                   

Well, I think this discussion acts as a nice framework. So first, why should I participate in this clinical trial? Meaning, what is it about my disease that makes a different treatment option a consideration? So, why to begin with? And, if so, why this trial? What drug is it? Why does it help? If it was successful, what can I expect?

Then, what is entailed with me to participate? How frequently do I need to come? What’s involved? Is there more expenses that I can anticipate?

Again, in general, I can hopefully say no. But, of course, if you’re having to fly once a month, that, in some trials, may be covered as an expense of the trial and you’re reimbursed, but it may not. So, again, I think it starts with, medically, why does it make sense? What is involved for me? And then, really, what are those other next steps? And then, what are the alternatives? Sometimes there’s more than one clinical trial as an alternative. Sometimes there’s other options that are not a clinical trial that are an alternative to consider as well.

Katherine:                  

Before we end the program, Dr. Mesa, I’d like to get your thoughts. What message would you like to leave the audience with related to clinical trial participation?

Dr. Mesa:                   

Clinical trials are essential.

They are really the only way that we make progress in terms of developing new treatments. In the United States, less than 10 percent of patients with diseases like MPNs and cancers participate in clinical trials. And, to be honest, this really slows our ability to develop new therapies that would benefit folks. These are a very important resource.

I’ll flip it around another way – in children, where, again, we want to do everything that we can – about 80 to 90 percent of children are treated in the conduct of a clinical trial, where, again, they’re constantly pushing the envelope to try to develop better therapies.

And because of that, I think our progress comparatively, in childhood cancers, has been much faster in developing therapies than it has been in adults. So, it’s critical. It’s an opportunity.

Again, it’s very much a personal decision, but it’s something that I would strongly encourage you to consider. Again, one can begin and you are not obligated to remain on if that clinical does not, in the end, end up having the benefit that you had hoped, or if it ends up having a side effect that you prefer to not experience.