Tag Archive for: clinical trial participation

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. 

The Risks and Benefits of Participating in an MPN Clinical Trial

The Risks and Benefits of Participating in an MPN Clinical Trial from Patient Empowerment Network on Vimeo.

What are the risks and benefits of MPN clinical trial participation? Dr. Angela Fleischman discusses clinical trial risks, benefits, safety protocols, monitoring, and importance of clinical trial participation.

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:

When should a patient consider participating in a clinical trial? 

Dr. Fleischman:

Okay, well, I guess a patient could really consider participating in a clinical trial at any point if they had a very altruistic philosophy, that understanding that their participation may not necessarily help them at this moment in time, but may help others in the future, and we’ll gain knowledge about myeloproliferative neoplasms. 

That’s one approach. Another approach, which is probably a more usual approach, is when a patient has already tried standard therapies and they haven’t quite worked for them, or they’re in a class where, maybe, we don’t have really great standard therapies for somebody. 

For example, a myelofibrosis who may not be doing too well and may not necessarily be a candidate for a transplant, I think that’s a very reasonable population to go out and seek clinical trials, because there’s really not necessarily a great standard of care treatments for that patient population, or ET or PV patients who have tried standard of care and, maybe, can’t tolerate standard medications, or they’re just not working for them. 

But really, anytime somebody can do a clinical trial, if that’s what they feel is important to them. 

What are the benefits and risks of a trial participation? 

Dr. Fleischman:

So, the benefits are that you’re getting a drug that, potentially, is better than standard of care, that could be standard of care five to 10 years from now, but you’re getting it early.  

As investigators, ethically, we can’t start a clinical trial if we believe that the drug that we’re testing might have negative side effects on the patient, or maybe worse than standard of care. I mean, ethically, that’s not appropriate. So, ethically, we believe that what we’re testing may be better than what we’re currently giving patients, but we don’t know that. So, that’s the purpose of a clinical trial. 

So, a clinical trial, it’s a new drug. So, could have side effects that are unanticipated, including death. I mean, that’s just the reality. That would be a very uncommon scenario, but it’s an unknown, so it’s an unknown. 

Other things that I think are very important to discuss are the financial implications of a clinical trial. On the pros, one could be getting a free drug that is outside of standard of care, and many of the tests that are done for the purposes of the research are covered. However, drugs, say, if it’s a combination drug, standard of care plus a new drug, the standard of care drug is usually billed to insurance. And so, the patient would need to pay for that, or if there are studies that would be considered standard of care, the patient would need to cover them. 

So, I think it, really, is important to discuss the financial implications. What money is it going to save you by participating, and may there be extra costs, or hidden costs, potentially, involved by participating? 

Katherine:

Yeah. Let’s talk about safety in clinical trials. Would you review the safety protocols that are in place before a clinical trial even begins? 

Dr. Fleischman:

So, before a clinical trial begins, there, usually, needs to be safety information in animals. Also, a lot of drugs have been tried in other diseases first. Either, they’re, have been studied in clinical trials and maybe not found to be very efficacious, but at least we have the value of the safety data in another population. 

So, we’re entering, again, into clinical trials with the understanding that it would not be harmful to humans with the data that we have available in animals, or in liquid culture. But again, we just don’t know that. And then, also, for many clinical trials, starting off at lower doses, and then, increasing the dose slowly in different cohorts of patients, to see what’s the maximally tolerated dose. 

As well as, when somebody is on a clinical trial, safety and side effects are very closely monitored, and even small side effects that likely have nothing to do with the drug, really do need to be investigated fully, just to make sure that they’re not related to the drug. 

Katherine:

Yeah. How do you know if the medicine is safe prior to starting a human trial? 

Dr. Fleischman:

That’s a great question. 

Based on what the molecule looks like, as well as, many times, they’ve been tested in animals to see – for example, for myeloproliferative neoplasm, it would be important to know, does it change a healthy rat’s blood count? Does it harm their liver? Those sorts of things, and safety information is usually available for a new drug. 

Katherine:

Are patients monitored more closely when they’re in a trial? 

Dr. Fleischman:

Yes, definitely. And for the purposes, mainly, of paying very close attention to even small side effects that, if somebody was not watched closely, may be missed because they’re so subtle. 

Katherine:

But what if they don’t? Why is it crucial that patients participate in trials? 

Dr. Fleischman:

Because without participation in clinical trials, we are not going to further our understanding of myeloproliferative neoplasm. Many of the drugs that we use today in myeloproliferative neoplasms, as well as other diseases, the reason why we use them today is because people 10, 20 years ago participated in the clinical trial and demonstrated a benefit of these medications. So, people don’t participate, we’re not going to have new drugs for myeloproliferative neoplasms.  

Advancing MPN Research: How Clinical Trials Work

Advancing MPN Research: How Clinical Trials Work from Patient Empowerment Network on Vimeo.

How do clinical trials advance MPN research? Dr. Angela Fleischman shares insight about the clinical trial process and the significance of clinical trials in moving MPN research forward.

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.

See More From MPN Clinical Trials 201

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Transcript:

Dr. Fleischman:

Well, there are multiple stages of clinical trials. One needs to have some rationale for testing a specific drug in patients. You just can’t say, I just want to take something off the shelf and see if it works for myeloproliferative neoplasms. 

There could be different ways that things sort of enter into clinical trials, either preclinical data from in vitro, meaning, in the lab, in the liquid media, with cells, that makes somebody think that it might work in humans, or that it works in a similar disease to myeloproliferative neoplasm. So, it’s a little bit of a stretch, but a very rational stretch, to then test it in a new population. 

First and foremost, safety needs to be evaluated, because as physicians, one of our primary objectives is to do no harm to patients. So, at very early stages of clinical trials, the primary objective is to see what the appropriate doses, what’s tolerated, what the side effect profile is. 

And then, moving on to efficacy. So, maybe it’s tolerated, but does it actually work at the next stage of clinical trials. Then, a much larger clinical trial would be to do a head-to-head comparison between, in most cases, standard of care versus drug X. 

And I think, for clinical trials, in particular, for myeloproliferative neoplasm, it’s very important to understand what the stated, primary end point is, in particular, for myelofibrosis patients, that myelofibrosis patients may have different problems. Some myelofibrosis patients, their primary issue may be anemia. And so, if they’re looking for a clinical trial to address their anemia, they would probably want to be looking for one whose primary end point is transfusion, freedom from transfusions, or improving the anemia, not necessarily – there was another trial that’s primarily looked at spleen reduction, but they didn’t have an enlarged spleen, that, necessarily, wouldn’t be appropriate for the patient. 

So, I think it is particularly important in myeloproliferative neoplasm to identify what the primary end point is, and whether what you’re going for is that primary end point. 

Katherine:

Mm-hmm. Any advances that are being done in MPN research require MPN patients to participate in clinical trials, right? 

Dr. Fleischman:

Of course. 

Katherine:

But what if they don’t? Why is it crucial that patients participate in trials? 

Dr. Fleischman:

Because without participation in clinical trials, we are not going to further our understanding of myeloproliferative neoplasm. Many of the drugs that we use today in myeloproliferative neoplasms, as well as other diseases, the reason why we use them today is because people 10, 20 years ago participated in the clinical trial and demonstrated a benefit of these medications. So, people don’t participate, we’re not going to have new drugs for myeloproliferative neoplasms. 

Developing CLL Research and Treatment News

Developing CLL Research and Treatment News from Patient Empowerment Network on Vimeo.

CLL expert Dr. Michael Choi provides his perspective on the goals of current CLL clinical trials, discusses approved inhibitor treatments, and shares credible resources to keep up with the latest news in research.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

See More from CLL Clinical Trials 201

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Transcript:

Laura Beth:

Dr. Choi, are there recent advances in CLL treatment and research that you are excited about?  

Dr. Choi:

There’s certainly a lot to be excited about as far as new treatments or new understanding of our treatments. What I see as kind of two main aims of trials right now for our patients with CLL, one is to figure out the optimal way to treat patients, especially in the first line of treatment.  

For the past few years, we’ve had two very clear options, two very clear standards, a BTK inhibitor or the combination of venetoclax and a CD20 antibody. And so, right now, there are a couple of trials both in the states and internationally that are for the first time really comparing those head-to-head. At UCSD, we’re eagerly hoping to join one of those trials as well, and so this will help us and help our patients kind of really know which of those options make the most sense for maybe different subgroups of patients.  

I guess the other main emphasis is to have new therapies available to patients in case these existing standards stop working. And fortunately, this is not a common occurrence. Resistance to BTK inhibitors and Bcl-2 inhibitors is not common, fortunately. But we have to be ready with something if that does occur for our patients.  

Certainly, there’s a lot of enthusiasm for the next generation of BTK inhibitors, cellular therapies like CAR-T therapy, and other classes of medications. So, while I hope most of my patients never need those drugs or never need those trials, I think it’s important that we have those available.  

Laura Beth:

How can patients keep up to date on developing CLL research?  

Dr. Choi:

Oh, that’s a great question. I guess I sometimes ask that same question of myself. How can I stay updated on all the developments and discoveries. Yeah, I guess, yeah, certainly talking to your doctors about what other options there may be. Sometimes, that’s maybe the simplest question to ask.

Yeah, I wish online things were a little bit more straightforward. When I go onto clinicaltrials.gov, I pull up hundreds of different CLL trials, some that might not be relevant for all of my patients. I think The Leukemia & Lymphoma Society and other societies and your group as well have done a great job communicating what some of the most promising areas of research are.  

Hesitant to Participate in a CLL Clinical Trial? What You Should Know.

Hesitant to Participate in a CLL Clinical Trial? What You Should Know. from Patient Empowerment Network on Vimeo.

What should patients know about clinical trials? CLL expert Dr. Michael Choi explains patient trial opportunities and provides key questions to ask about clinical trial participation.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

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Transcript:

Laura Beth:

Dr. Choi, what would you say to someone who is perhaps a little hesitant to participate in a trial to encourage them to learn more?  

Dr. Choi:

Yeah, certainly, it’s very natural to be anxious and to be hesitant about entering into a clinical trial about volunteering to receive something that maybe hasn’t been fully tested before. You know, I think when I talk to my patients about trials, one thing I try to keep in mind is that ultimately, to a degree, to a large degree, we have our trials for our patients. We want to have our trials open at our center so that patients that can benefit from them can have access to them.  

And so, a lot of trials are really kind of designed in that way, to give patients a chance at something that we think will be better or a chance to get a drug when other drugs have stopped working. So, I think many clinical trials aren’t really with the thought that we want to prioritize the science and that our patients are just guinea pigs.  

In fact, I think all of us that are treating patients with CLL and being a part of CLL clinical trials, I think we’re really doing our best to prioritize our patients and their health. The trials are really just a part of that. But beyond that, I think maybe the questions that can be asked would be kind of what’s known already about these drugs. 

 Many trials are using drugs that we’ve already used for many years and maybe just using them in a different manner. So, talk to your doctors about what’s already known. Certainly, the question about how will they be monitored, that’s an important question for your team too. And then, certainly, make sure you understand if there are any other options that would be appropriate or good for you and discuss the pros and cons of the trial versus those options. 

How Does Patient Clinical Trial Participation Move CLL Research Forward?

How Does Patient Clinical Trial Participation Move CLL Research Forward? from Patient Empowerment Network on Vimeo.

Chronic lymphocytic leukemia (CLL) expert Dr. Michael Choi shares how clinical trial participation helps advance research and benefit the CLL community.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

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Transcript:

Laura Beth:

Dr. Choi, why is patient participation in CLL clinical trials so critical to advancing research?  

Dr. Choi:

Yeah, there’s still so much that we can do better for our patients. We’ve come a long way. I think we have a few – many treatments that we can really count on to work when we need it, but I think we still have a way that we can refine this more, which combination to use, which sequence to use, how long to do the certain treatments, and then, of course, what to do if those treatments stop working.  

So, I think, yeah, trials help us answer these questions in kind of formal manners so that the information can be used to help other patients in the future.   

Laura Beth:

I imagine that trial participation benefits the CLL community as a whole, by helping to move the research forward?   

Dr. Choi:

That’s so right, yeah. I’m always humbled and impressed by, I guess, the selflessness and the bravery of some of our patients, or of all of our patients and their families and their loved ones. Volunteering for a trial is certainly no trivial thing, not a trivial thing. And so, yeah, I think that that realization that by being a part of a trial, they’re not only potentially helping themselves and getting good care but also helping the future patients as well.  

A Patient’s Perspective | Participating in a Clinical Trial

A Patient’s Perspective | Participating in a Clinical Trial from Patient Empowerment Network on Vimeo.

Colorectal cancer survivor Cindi Terwoord recounts her clinical trial experience and explains why she believes patients should consider trial participation.

Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.

Cindi Terwoord is a colorectal cancer survivor and patient advocate. Learn more about Cindi, here.

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Transcript:

Katherine Banwell:    

Cindi, you were diagnosed with stage IV colorectal cancer, and decided to participate in a clinic trial. Can you tell us about what it was like when you were diagnosed?

Cindi Terwoord:        

Yeah. That was in September of 2019, and I had had some problems; bloody diarrhea one evening, and then the next morning the same thing. So, I called my husband at work, I said, “Things aren’t looking right. I think I’d better go to the emergency room.”

And so, we went there, they took blood work – so I think they knew something was going on – and said, “We’re going to keep you for observation.” So, then I knew it must’ve been something bad. And so, two days later, then I had a colonoscopy, and that’s when they found the tumor, and so that was the beginning of my journey.

Katherine Banwell:    

Mm-hmm. Had you had a colonoscopy before, or was that your first one?

Cindi Terwoord:        

No, I had screenings, I would get screenings. I had heard a lot of bad things about colonoscopies, and complications and that, so I was always very leery of doing that. Shame on me. I go for my other screenings, but I didn’t like to do that one. I have those down pat now, I’m very good at those.

Katherine Banwell:    

Yeah, I’m sure you do. So, Cindi, what helped guide your decision to join a clinical trial?

Cindi Terwoord:        

Well, I have a friend – it was very interesting.

He was probably one of the first people we told, because he had all sorts of cancer, and he was, I believe, one of the first patients in the nation to take part in this trial. It’s nivolumab (Opdivo), and he’s been on it for about seven years. And he had had various cancers would crop up, but it was keeping him alive.

And so, frankly, I didn’t know I was going to have the option of a trial, but he told me run straight to Cleveland Clinic, it’s one of the best hospitals. So, I took his advice. And the first day the doctor walked in, and then all these people walked in, and I’m like, “Why do I have so many people in here?” Not just a doctor and a nurse. There was like a whole – this is interesting.

And so, then they said, “Well, we have something to offer you. And we have this immunotherapy trial, and you would be one of the first patients to try this.”

Now, when they said first patient, I’m not quite sure if they meant the first colon cancer patient, I’m not sure. But they told me the name of it, and I said, “I’m in. I’m in.” Because I knew my friend had survived all these years, and I thought, “Well, I’ve gotten the worst diagnosis I can have, what do I have to lose?” So, I said, “I’m on board, I’m on board.”

Katherine Banwell:    

Mm-hmm. Did you have any hesitations?

Cindi Terwoord:        

Nope. No, I’m an optimistic person, and what they assured me was that I could drop out at any time, which I liked that option.

Because I go, “Well, if I’m not feeling well, and it’s not working, I’ll get out.” So, I liked that part of it. I also liked, as Dr. Funchain had said, you go in for more visits. And I like being closely monitored, I felt that was very good.

I’ve always kept very good track of my health. I get my records, I get my office notes from my doctor. I’m one of those people. I probably know the results of blood tests before the doctor does because I’m looking them up. So, I felt very confident in their care. They watched me like a hawk. I kept a diary because they were asking me so many questions.

Katherine Banwell:    

Oh, good for you.

Cindi Terwoord:        

I’m a transcriptionist, so I just typed out all my notes, and I’d hand it to them.

Katherine Banwell:    

That’s a great idea.

Cindi Terwoord:        

Here’s how I’m feeling, here’s…And I was very lucky I didn’t have many side effects.

Katherine Banwell:    

In your conversations with your doctor, did you weigh the pros and cons about joining a trial? Or had you already made up your mind that yes, indeed, you were going for it?

Cindi Terwoord:        

Yeah, I already said, “I’m in, I’m in.” Like I said, it had kept my friend alive for these many years, he’s still on it, and I had no hesitation whatsoever.

I wish more people – I wanted to get out there and talk to every patient in the waiting room and say, “Do it, do it.”

I mean, you can’t start chemotherapy then get in the trial. And if I ever hear of someone that has cancer, I ask them, “Well, were you given the option to get into a trial?” Well, and then some of them had started the chemo before they even thought of that.

Katherine Banwell:    

Mm-hmm. So, how are you doing now, Cindi? How are you feeling?

Cindi Terwoord:        

Good, good, I’m doing fantastic, thank goodness, and staying healthy. I’m big into herbal supplements, always was, so I keep those up, and I’m exercising. I’m pretty much back to normal –

Katherine Banwell:

Cindi, what advice do you have for patients who may be considering participating in a trial? 

Cindi Terwoord:

Do it. Like I said, I don’t see any downside to it. You want to get better as quickly as possible, and this could help accelerate your recovery. And everything Dr. Funchain mentioned, as far as – I really never brought up any questions about whether it would be covered. 

And then somewhere along the line, one of the research people said, “Well, anything the trial research group needs done – like the blood draws – that’s not charged to your insurance.” So, that was nice, that was very encouraging, because I think everybody’s afraid your insurance is going to drop you or something.  

And then the first day I was in there for treatment, a social worker came in, and they talked to you. “Do you need financial help? We also have art therapy, music therapy,” so that was very helpful. I mean, she came in and said, “I’m a social worker,” and I’m like, “Oh, okay. I didn’t know somebody was coming in here to talk to me.” 

But that was all very helpful, and I did get free parking for a few weeks. I mean, sometimes I’d have to remind them. I’d say, “It’s costing me more to park than to get treated.” But, yeah, like I said, I’m a big advocate for it, because you hear so many positive outcomes from immunotherapy trials, and boy, I’d say if you’re a candidate, do it. 

Katherine Banwell:

Dr. Funchain, do you have any final thoughts that you’d like to leave the audience with? 

Dr. Pauline Funchain:

First, Cindi, I have to say thank you. I say thank you to every clinical trial participant, everybody who participates in the science. Because honestly, whether you give blood, or you try a new drug, I think people don’t understand how many other lives they touch when they do that.  

It’s really incredible. Coming into clinic day in and day out, we get to see – I mean, really, even within a year or two years, there are people that we’ve seen on clinical trial that we’re now treating normally, standardly, insurance is paying for it, it’s all standard of care. And those are even the people we can see, and there are so many people we can’t see in other centers all over the world, and people who will go on after us, right?  

 So, it’s an amazing – I wouldn’t even consider most of the time that it’s a personal sacrifice. There are a couple more visits and things like that, but it is an incredible gift that people do, in terms of getting trials. And then for some of those trials, people have some amazing results. 

And so, just the opportunity to have patients get an outcome that wouldn’t have existed without that trial, like Cindi, is incredible, incredible. 

Emerging Approaches in Bladder Cancer Treatment

Emerging Approaches in Bladder Cancer Treatment from Patient Empowerment Network on Vimeo.

Dr. Shilpa Gupta of the Cleveland Clinic shares a promising update in bladder cancer treatment and research, including the benefits of patient participation in clinical trials. 

Dr. Shilpa Gupta is the Director of the Genitourinary Medical Oncology at Taussig Cancer Institute and Co-Leader of the Genitourinary Oncology Program at Cleveland Clinic. Dr. Gupta’s research interests are novel drug development and understanding biomarkers of response and resistance to therapies in bladder cancer. Learn more about Dr. Gupta, here.

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Transcript:

Katherine:                  

So, Dr. Gupta, are there emerging approaches for treating bladder cancer that patients should know about?

Dr. Gupta:                  

Yes, absolutely. I would say that the field is so rife with so many different treatment approaches and ways to offer more personalized medicine. We know, for example chemotherapy followed by surgery has been the gold standard, but we have seen data that there are certain genes in some patients’ tumors which may predict how well they will respond and potentially we could avoid a life-changing surgery like cystectomy.

And we have trials with immunotherapy adding to chemotherapy in bladder preservation approaches along with radiation. So, these are some of the new work that’s been done. Approaches to intensify the effect of BCG in newly diagnosed non-muscle invasive bladder cancer patients are also ongoing. Then, in the metastatic setting, we have so many treatment options that have become approved in the last couple of years, now the goal is, well, how to sequence the therapies best for the patient and whether in the front-line therapy we can actually get rid of chemotherapy.

Some of these antibody drug conjugates and immunotherapy combinations are proving to be very effective and the hope is that one day patients may not need chemotherapy because we have chemo-sparing regimens. So, there’s a lot going on and I think the progress has been tremendous in the past few years.                                            

Katherine:                  

Some patients may be fearful when it comes to clinical trials. So, what would you say to someone who might be hesitant to consider participating in one? 

Dr. Gupta:                  

I would say there’s a lot of misconceptions out there that going on a trial is like being a guinea pig or you get a placebo. For the most part, patients are getting active drugs whenever possible. The only time where we have placebo-controlled trials is if, for that particular setting, there is no approved treatment. But I think patients should get all the information from their doctors and the study teams about the pros and cons.

Many times, it’s about – you could do the study because the patients meet the criteria and are fit to do it and if they wait for later, they may not be eligible anymore for whatever reasons.

I always put it this way, that standard of care therapies will still be available, but studies are sometimes with a tight window and tight criteria. So, I think patients should know that all these studies that are out there are very ethical and use the best possible control arm. So that even if they don’t get that experimental drug, they still get what is the standard of care unless it is something really being compared to nothing.