What Are Common Barriers to Clinical Trials Access?
What Are Common Barriers to Clinical Trial Access? from Patient Empowerment Network on Vimeo.
Clinical trials are key to the approval of new breast cancer treatments. But what factors could prevent some patients from participating? Expert Dr. Jame Abraham reviews common barriers and emphasizes the commitment of the oncology community to improving trial access.
Dr. Jame Abraham is the chairman of the Department of Hematology & Medical Oncology at Cleveland Clinic and professor of medicine at Cleveland Clinic Lerner College of Medicine. Learn more about Dr. Abraham.
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When Should Breast Cancer Patients Consider a Clinical Trial? |
Transcript:
Katherine:
Dr. Abraham, what are barriers to accessing clinical trials?
Dr. Abraham:
That’s a really good question. I think we need to continue to work on breaking down the barriers. And the most common barrier is, wherever she, or he, are going for the treatment, they don’t have access to a client. There’s no trial available. The second, let’s just say, if I can say, the lack of awareness from the provider, or the patient’s side, about the importance of trial. And then, third, some trials can be complicated. So, it requires multiple appointments, or multiple trips to the doctor’s office, or the hospital, or the cancer center. So, that may not be feasible for everybody. Somebody has limited access, limited support, it can be tough.
And then, let’s just say, that people have comorbid conditions, if I can say. Other conditions, heart disease, or other things, or they’re not able to be more active, and some of those things, can make that person ineligible for a trial.
So, there are a number of things, potentially, can be barriers, but I think, as an oncology community, as cancer centers, we need to continue to work on optimizing, or breaking down, these barriers.
As a nation, we have a huge – we have a lot of work in addressing the disparities in cancer care.
As you know, where you’re born, and it can be innercity, Cleveland, innercity, Detroit, or it can be in the Appalachia, where you’re born, and what’s your access to healthcare, that plays a major role.
And, of course, your race, and your education, I know that plays a major role in access to healthcare, and then, able to continue with treatment, and that plays a similar role in clinical trials, too. So, the number of patients entering clinical trials from different race, especially African American patients, are less, compared to the other patient population. So, there is a lot of work, need to be done, in addressing the disparities in cancer care, in general, and especially clinical trials.
Katherine:
And I imagine that’s a focus for many of the people working on trials?
Dr. Abraham:
It’s a focus for National Cancer Institute, it’s a focus for all the cancer centers, absolutely.
Breast Cancer Clinical Trials | What Are the Phases?
Breast Cancer Clinical Trials | What Are the Phases? from Patient Empowerment Network on Vimeo.
What do breast cancer patients need to know about the phases of a clinical trial? Expert Dr. Jame Abraham explains the trial process and reviews what happens during each phase.
Dr. Jame Abraham is the chairman of the Department of Hematology & Medical Oncology at Cleveland Clinic and professor of medicine at Cleveland Clinic Lerner College of Medicine. Learn more about Dr. Abraham.
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When Should Breast Cancer Patients Consider a Clinical Trial? |
Transcript:
Katherine:
Dr. Abraham, many people are confused about how breast cancer clinical trials are conducted. What are the phases of a clinical trial?
Dr. Abraham:
So, that’s a really good question. It’s a really important question. And I’m kind of saying, there’s so many new things, and I’m talking about genomic testing, and I’m talking about all these new treatments. As I mentioned, I’ve been doing breast cancer for 20 years. So, every year, we are making huge progress in the treatment of breast cancer. Even then, more than 40,000 women will lose their life because of breast cancer. So, we have a long way to go. As you know, the only way we can make things better for tomorrow is by doing clinical trials. And there are so many different types of clinical trials. I’ll talk about that in a second.
Every new treatment we have today is coming out through a clinical trial, and someone, somewhere, said yes to a new treatment, or will be part of a trial. And that’s the reason we have a new drug today, and that’s making things better for tomorrow.
So, a clinical trial is extremely important, and I’ll say, a clinical trial is the gold standard of cancer treatment. And unfortunately, only less than seven percent of adults in the U.S. are enrolled in a clinical trial. Well, of course, that’s many reasons for that, but let me just make it clear. I know people sometimes worry, “Oh, by being part of a clinical trial, I’m a guinea pig.” No. No, no. Clinical trials are run with high ethical standards. So many committees review that, make sure it’s scientifically sound, it’s safe, and it protects the patient.
So, there’s so many layers of protection for the patients before anyone enters in a clinical trial.
So, there are treatment trials and non-treatment trials, and I’ll focus on – let me focus on treatment trials, not which other ones are making all these changes in the clinic. So, I’ve been doing trials for the last 20 years or so, or being part of a number of regional, and national, or global clients.
So, there are three major types of trials. One, because Phase I, Phase I. That’s the earliest form of clinical trial, and we have some, what they call as, preclinical data. A drug is found to be promising, but we don’t have too much, if I can say, data, in patients, or humans.
So, Phase I is the first human trial, which is looking for the right dose of the drug, what side effects we can expect, and we kind of look at how the drug is metabolized in the body. So, that’s the Phase I trial.
The second one is Phase II, Phase II trial. Phase II trials are looking for efficacy, and how active this drug is in breast cancer. And the third type of trial is Phase III, Phase III. Phase III is what we call as, randomized trials. Means there’s a standard treatment, and now, we have this new drug. The question is, is the new drug better than the standard treatment? So, Phase III, it’s randomized. It’s divided into two groups. One group will get the standard treatment, and the second group will get this new treatment.
And then, we’ll come back and compare these two, and see which is better. That’s Phase III.
So, there is Phase IV, that’s, they call as, a post-marketing study, and once the – based upon the phase, early phase trials, the FDA can approve, or not approve, a drug. And let’s just say, if it’s approved, it’s in the market. Then, the patients can potentially go for a, what we call as, phase – I mean, potentially, we can do a Phase IV study. That’s post-marketing study.
What Should You Know Before Participating in a Breast Cancer Clinical Trial?
What Should You Know Before Participating in a Breast Cancer Clinical Trial? from Patient Empowerment Network on Vimeo.
Is there a point in a patient’s breast cancer care when a clinical trial should be considered? Breast cancer expert Dr. Bhuvaneswari Ramaswamy shares her perspective.
Dr. Bhuvaneswari Ramaswamy is the Section Chief of Breast Medical Oncology and the Director of the Medical Oncology Fellowship Program in Breast Cancer at The Ohio State College of Medicine. Learn more about Dr. Ramaswamy.
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Transcript:
Katherine:
Well, what questions should patients ask their team before they even begin a clinical trial?
Dr. Ramaswamy:
I think most important thing, and in – and usually, a doctor would – should really explain this to you, particularly if it’s a little bit of a complex study with a paper and pen. They need to tell you if this is two arms, that you may be randomized into this arm versus this arm. So, what you need to understand is what are the drugs and what are the differences between these two arms? Whether you go into this arm or this arm, are you going to be compromised with your outcomes? And that is important to understand. And now certain arms may have a little bit more blood draws or scans. And so it’s important to understand what it means, what commitment of your time and other things that goes on with different treatments.
So, again, these are important for you to understand. Also, it’s important for you to know what is that experimental drug? What is that new drug? Right? And what data do they have from the past about this drug? Has it been tried in humans before or is this the first in the human study? And what does a target, why is it used in my cancer? How do you think it’s going to work? And what are the side effects that comes with this experimental drug? Mm-hmm. I think for you, the most important thing is to understand what is your commitment because the commitment during clinical trials can increase a little bit. You may have to come in, stay a bit longer to kind of check the drug levels in your body, in your blood, or do more testings, blood draws, and things like that.
Are you willing to do that? That’s something for you to answer. Don’t feel that you need to do this for some reason other than it fits your life and it fits your philosophy, okay? But also don’t push it away thinking that just because you don’t know enough and you’ve heard things from outside, it’s important for you to hear it from your providers and understand it clearly and then make a decision that’s right for you.
When Should Breast Cancer Patients Consider a Clinical Trial?
When Should Breast Cancer Patients Consider a Clinical Trial? from Patient Empowerment Network on Vimeo.
Is there a point in a patient’s breast cancer care when a clinical trial should be considered? Breast cancer expert Dr. Bhuvaneswari Ramaswamy shares her perspective.
Dr. Bhuvaneswari Ramaswamy is the Section Chief of Breast Medical Oncology and the Director of the Medical Oncology Fellowship Program in Breast Cancer at The Ohio State College of Medicine. Learn more about Dr. Ramaswamy.
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Transcript:
Katherine:
Let’s talk about where clinical trials fit into a breast cancer treatment plan. When should someone with breast cancer consider a trial?
Dr. Ramaswamy:
And the most important thing again here to understand is clinic – you should consider a clinical trial at all aspects, all parts of your journey through this whole diagnosis and whatever the outcomes that you are going to have. We all have a lot of misconstrued ideas about clinical trials. And one of the thing is we think clinical trials are only when standard of care is not needed like that is that – we don’t have other treatments. That you are coming to a point that you don’t have other treatments and now you should go to clinical trials. That is not true, right? Because the fact that you can have these treatments in your curative setting came because many of the patients before you were willing to go on the trial that compared standard of care, which may not have had that new drug with a competitor to the new drug with the standard of care.
So, nobody gives – the important thing to understand is no one is going to give you a placebo alone for cancer treatment. Think about that. I mean, there’s no way a doctor whose oath is to cure you to help you is going to just give you placebo. So, it is important for you throughout your process to actually ask. In fact, we used to wear a badge to say ask your doctor about clinical trials. So, ask your doctor about it, even if they miss it. Just ask, is there a clinical trial that I could fit in? They’re supposed to look for it, but you don’t need to leave it at that.
Ask at all aspects of your journey for a clinical trial option. If you are not suited for the trial, no provider is going to put you on that trial because everybody has the same goal that you need to get better. Your chances of getting better is high.
Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial
Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial from Patient Empowerment Network on Vimeo.
What questions should breast cancer patients ask their healthcare team before entering a clinical trial? Dr. Adrienne Waks shares her advice and key questions that breast cancer patients should ask before participating in a trial.
Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.
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Transcript:
Katherine:
What are some key questions patients should ask their healthcare team about participating in a trial?
Dr. Waks:
Yeah, I think there’s a couple of major ones. What’s the rationale behind this trial? Why do you think it might be better than the standard? What do I stand to gain in terms of effectiveness? Do you think it could be worse than the standard of care, and why or why not? So, basically, trying to capture well, what’s the rationale and the potential benefit of a trial? We’re always doing trials to try to give the patient some sort of benefits, so very reasonable to ask about that. Number two, of course, is what are the extra side effects that could be associated with participation on this trial, and how much do you know about them?
Is this a drug that you’ve used for five years in a different context or is it a pretty new drug and you don’t have a great sense, so number two, what are the side effects potentially associated with participation on the clinical trial? And then the third thing I would say is what is the extra burden on me going to be, not in terms of side effects but in terms of life disruption, time spent and things like that? What are those extra burdens going to be if I participate in a clinical trial will I have to get extra scans, will I have to do extra visits, will I have to get extra biopsies?
You know, there are a number of clinical trials that require biopsies or have optional biopsies at least because in addition to studying a new drug we’re trying to understand in whom does it work and in whom does it not. And so, we want to have biopsies to help us understand that, but a patient should obviously want to be informed about those biopsies.
So, what will the extra on me look like? And then, we always try as investigators in a clinical trial to put in place as best we can some ways to sort of mitigate the burden on patients. Like, well if I have to have a biopsy, can my parking be covered that extra day or what accommodations can be made to try to mitigate some of the disruption or the extra time? So, I would say those are sort of the three or four main things to ask about.
Should Breast Cancer Patients Consider a Clinical Trial?
Should Breast Cancer Patients Consider a Clinical Trial? from Patient Empowerment Network on Vimeo.
Dr. Adrienne Waks, a breast cancer expert, discusses why and when patients should consider participating in a clinical trial.
Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.
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Transcript:
Katherine:
Why should a breast cancer patient consider participating in a clinical trial?
Dr. Waks:
It’s a great question. I always tell patients and, of course, I work at Dana Farber, so we participate and I come to this question with a bias and a huge enormous amount of belief in the importance and the value of clinical research, but I honestly would encourage all patients to encourage clinical trials at all points in their breast cancer care. I think that often patients think that clinical trials are something that your doctor will bring up when you’re scraping the bottom of the barrel in terms of cancer treatment options.
You know, you’ve exhausted everything that’s good and now we’re going to give you treatments that were given to the mice last week or something like that. But that could not be further from the truth. At every stage of breast cancer treatment whether you have a stage I breast cancer or you have a metastatic breast cancer, all of the current standards for how we treat patients and all of the data that we have to tell us you should use those treatments because they’re beneficial, all of those standards and those data come from patients who came before you who participated in clinical trials. Those were not patients who were at the very last stage of their cancer treatment.
They were patients who could have been newly diagnosed with a Stage I breast cancer, newly diagnosed with metastatic breast or something like that. We change the standards of how we treat patients at all stages by running clinical trials.
In breast cancer, we have such effective treatments that it’s virtually unheard of that we would compare something to nothing. There’s almost never a time in breast cancer treatment when it’s ethical to offer nothing as a therapy, so most of our clinical trials are not saying you might get a placebo sugar pill and that’s it. It’s saying either you’ll get Arm A, which is this agent or you’ll get A plus B which is the standard plus something else. So, it’s not like by participating in a clinical trial you’re omitting standard therapy. What we’re generally trying to do is give you standard therapy and something better or replacing a part of standard therapy with something we think is going to do better.
Every time we design and implement a clinical trial, we’re obviously doing so because we hope that we can improve upon the current standard. So, there certainly isn’t a trial for everybody at every stage in their treatment course, and it’s absolutely fine if there’s no trial ongoing that’s the right fit for you, but I think it’s always a good question to ask. You know, is there a trial I should consider here?
Hesitant to Join a Breast Cancer Clinical Trial? What You Should Know.
Hesitant to Join a Breast Cancer Clinical Trial? What You Should Know. from Patient Empowerment Network on Vimeo.
What do breast cancer patients need to know about clinical trials? Breast cancer expert Dr. Adrienne Waks addresses common concerns and misconceptions about trial participation.
Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.
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Transcript:
Katherine:
What would you say to patients who may be hesitant to participate in a trial?
Dr. Waks:
That’s a great question. I think many patients are at first hesitant to participate in a trial, which is natural. You know, there’s already so many overwhelming and scary decisions to be made when it comes to getting a breast cancer diagnosis or any cancer diagnosis that introduce a whole other set of discussions. Instead of variables, it’s found extremely overwhelming and adds another level of what might feel like uncertainty, so I think that’s a completely natural response is to be hesitant and overwhelmed if somebody brings up the clinical trial.
But what I would try to address in terms of patient concerns is number one, I think that patients worry that if they are approached about a clinical trial that means there aren’t other good options available to them which not always, but almost always is actually far from the truth. Usually it’s just because we have a standard, we think it’s pretty good but we’d like to do better than the standard and participating in a clinical trial is how we do that.
So, first I always, of course, assure patients this clinical trial is not like something we’ve never tested before and we know nothing about it, and it’s not because I don’t have other options for you. It’s just because I want to do better than the existing options and often it’s looking at an agent that’s already FDA-approved, but we’re trying to combine it with a different agent or something like that.
So, obviously, number one try to give patients some reassurance about what we already know about the trial agents and also reassure them about the fact that we don’t anticipate the efficacy of their treatment overall would be compromised. Rather we’re trying to improve upon that. So, I think that’s probably the most common concern that I hear from patients, but, of course, as providers it’s our job to understand from that specific patient who’s in front of you what are your particular concerns about clinical trials in general. And are those misconceptions that I can dispel for you, or are they real things that some women on trials do experience in which case we should talk through them and decide if it’s the right fit for you.
It’s almost always true that participating in a clinical trial does come with what I always call a few other hoops to jump through, because when you’re participating in a clinical trial we want to learn from your experience. So, we do want women to complete questionnaires about their side effects or have a second appointment one week later so that we can do an extra side effect check-in or something like that. You know, do an EKG that they wouldn’t otherwise need. So, there can be and often are some additional logistical or scheduling components that come with participation in the trial.
Again, we would want a patient to voice how that might or might not fit into her life and be very up front about what could be expected in terms of additional asks which can be extremely minimal or sometimes more disruptive depending on the trials. So, obviously, we just need to have a conversation about that.
