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.

See More from Breast Cancer Clinical Trials 201

Related Resources:

What Role Do Breast Cancer Patients Play in Care and Treatment Decisions?

Should Breast Cancer Patients Consider a Clinical Trial?

Hesitant to Join a Breast Cancer Clinical Trial? What You Should Know.


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.

See More from Breast Cancer Clinical Trials 201

Related Resources:

What Role Do Breast Cancer Patients Play in Care and Treatment Decisions?

Hesitant to Join a Breast Cancer Clinical Trial? What You Should Know.

Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial


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.

See More from Breast Cancer Clinical Trials 201

Related Resources:

How Is Metastatic Breast Cancer Treated?

Should Breast Cancer Patients Consider a Clinical Trial?

Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial


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. 

Why Should Breast Cancer Patients Feel Empowered to Speak Up About Their Care?

Why Should Breast Cancer Patients Feel Empowered to Speak Up About Their Care? from Patient Empowerment Network on Vimeo

Why is it important for breast cancer patients to speak up and have a voice in their care? Breast cancer expert Dr. Adrienne Waks shares her perspective encouraging patients to ask questions and understand their care.

Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.

See More from Thrive Breast Cancer

Related Resources:

What Role Do Breast Cancer Patients Play in Care and Treatment Decisions?

What Are the Treatment Options for Early Stage Breast Cancer?

How Is Metastatic Breast Cancer Treated?


Transcript:

Katherine:

Why should patients feel empowered to speak up and ask questions? 

Dr. Waks:

Well, I think for all sorts of different reasons. I think in breast cancer there are times when there’s a very clear right answer and right path forward and then a variety of other options that are clearly not recommended, not standard of care inadvisable, dangerous whatever, so there’s plenty of circumstances where that’s the case. But there’s also lots of circumstances, probably the majority of decisions that a patient has to make over the course of her or his breast cancer treatment plan and a variety of circumstances where there’s actually a number of different reasonable paths forward. 

Again, I think that’s the physicians or the nurse practitioner, the infusion nurse, whatever healthcare practitioner is helping to guide the patient through that particular decision, it’s our role to help lay out those options. Ultimately, we will always look to the patient for the most important final decision, so in order to make that decision, a patient needs to ask questions and help us understand where is she or he coming from, and what are their values and what are their competing interests, competing priorities outside of their breast cancer diagnosis, what is the most important outcome, a thing they want to maximize most, a thing they don’t really care about. 

We’ll never be able to bring that perspective to the table. We always look to the patient to do that. 

And so, they’re only get there by asking questions. Obviously, we’re going to try our best to anticipate all of the questions and lay out the options as comprehensively as we can, but there will always be things we can’t anticipate and things that are important to the patient that we just simply could never know about. So, we understand, appreciate, expect, and hope that a patient will ask questions and even more so that their accompanying family member or friend will do the same. 

What Role Do Breast Cancer Patients Play in Care and Treatment Decisions?

What Role Do Breast Cancer Patients Play in Care and Treatment Decisions? from Patient Empowerment Network on Vimeo

What is shared decision-making? Breast cancer expert Dr. Adrienne Waks outlines the shared decision-making process and explains how patients can play an active role in their care.

Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.

See More from Thrive Breast Cancer

Related Resources:

Why Should Breast Cancer Patients Feel Empowered to Speak Up About Their Care?

What Are the Treatment Options for Early Stage Breast Cancer?

How Is Metastatic Breast Cancer Treated?


Transcript:

Katherine:

What is shared decision-making, and how does it work? 

Dr. Waks:

So, to me basically what that means is that patients and providers are working together to decide what are the best steps to take in a patient’s treatment plan, essentially. I see my role as the provider being to lay out the menu of options and try to, of course, offer some guidance about which might be the best, which are less preferred, why that is. But then, to guide the discussion and then have the subsequent conversation with the patient about how do they take in that information, what feels like the right fit to them and then incorporate their preferences into the actual plan we make in terms of how to go forward. 

Katherine:

Well, what role do patients play in the decision-making? 

Dr. Waks:

I think the patients play the most important role ultimately. You know, what I always say to patients is I’m always going to try to offer my opinion. Again, lay out a variety of different options and then offer my opinion because I think I would imagine it could be frustrating if you’re a patient and you go to a doctor and they say like here are five options, and you can just select between them. So, it’s definitely I think the physician’s role to try to put some value judgments or comparisons of the different options, but ultimately, basically every single decision is the patient’s, and I can tell them that’s what I would have done or that’s not what I would have done, but I understand where you’re coming from. 

Again, it’s not like your physician isn’t there to guide you and give feedback and try to tell you what the best choice is. But actually ultimately in breast cancer management and in a free medical issue, it is ultimately the patient’s decision, so their voice is the most important one. 

What Are the Treatment Options for Early Stage Breast Cancer?

What Are the Treatment Options for Early Stage Breast Cancer? from Patient Empowerment Network on Vimeo.

Breast cancer expert Dr. Adrienne Waks reviews available treatment approaches for patients with early stage breast cancer and explains the role of sub types when choosing a treatment plan.

Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.

See More from Thrive Breast Cancer

Related Resources:

What Role Do Breast Cancer Patients Play in Care and Treatment Decisions?

Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial

How Is Metastatic Breast Cancer Treated?


Transcript:

Katherine:

Well, let’s get into the specific treatment options that are available for breast cancer patients. Could you tell us about those?  

Dr. Waks:

So, fortunately, the answer to that question is enormous, because we have so many effective treatment options in breast cancer and generally our patients do very well in the long term when they are diagnosed with early stage breast cancer, so stage I or II or III breast cancer.  

That might involve the breast, it might involve the lymph nodes under the arm, but it hasn’t traveled anywhere else in the body. So I’ll set aside metastatic breast cancer and just talk about stage I, II, and III. 

So, as you may know, we think about as medical oncologists we completely separate treatment considerations for three different subtypes of breast cancer. Those are hormone receptor-positive, HER2-positive and then triple-negative. So, again, highlighting just important developments and not really the overall treatment planning for each of those subtypes, in ER-positive disease or estrogen receptor-positive disease hormonally-driven, estrogen-driven breast cancer – those are all sort of terms for the same thing, I think there have been a couple of important developments over the last few years.  

Probably the most important recent one is the new understanding and demonstration that the CDK4/6 inhibitor abemaciclib, the brand name of that drug is Verzenio. 

That drug when we administer it for two years after a patient has had their surgery and in conjunction with alongside the antiestrogen medicines; the antiestrogen medicines are usually done for a minimum of five years, when we add on to that the CDK4/6 inhibitor abemaciclib, we see that for women with higher risk disease, so maybe some lymph node involvement or a large tumor in the breast or both that the addition of the Verzenio, the abemaciclib seems to decrease their risk of recurrence of breast cancer a couple of years out. So, that’s been an important exciting development. 

Again, not for all women within early stage estrogen-driven breast cancer, but for a little bit more advanced early stage disease like lymph node involvement. You know, we’re obviously always looking for ways to reduce that risk of recurrence for women who have a little bit more risk at diagnosis and the addition of abemaciclib was an exciting and welcome addition to our toolkit there. 

In HER2-positive disease, which is about 20 percent of breast cancers overall, I think what the recent years have brought us is increasing understanding that in many cases we give women too much chemotherapy and that we need to be – so, here it’s less about adding on. Like the Verzenio example I was just talking about and more about individualizing and figuring out in whom and how we can pull back from sort of the kitchen sink approach that we take often to treating a HER2-positive early stage breast cancer and be more thoughtful and more personalized in the amount of treatment that we give women with HER2-positive breast cancer. 

The reason for that is that we’re basically 20 years into understanding that for HER2-positive breast cancers we can treat those cancers very effectively with anti-HER2 antibody drugs like trastuzumab or Herceptin. We didn’t even know that until 20 years ago. And so, Herceptin, trastuzumab and similar drugs have really revolutionized how effectively we can treat women with HER2-positive breast cancers. And so, at this point, it’s becoming more and more clear that we can really lean more on our arsenal of anti-HER2 targeted therapies like Trastuzumab. Pertuzumab (Perjeta) is another one and trastuzumab MTNC and TDM1 is another one. 

So, we have all these excellent smart targeted treatments for women with HER2-positive disease, but yet the standard of care is still to give all those good rational targeted treatments with a whole bunch of chemotherapy that comes with a lot of side effects. 

I think more and more we’re figuring out that we can lean more on our anti-HER2 treatments and require less of the really side effect heavy chemotherapy, but how do we do that thoughtfully? We obviously don’t want to undertreat anybody, so how do we do that thoughtfully? How do we pick out the women who only need the anti-HER2 treatment and can get away with less chemotherapy. I think that’s really what’s exciting in HER2-positive early stage breast cancer right is how do we individualize and take advantage of targeted agents that we have? 

And then finally, in the third subtype of breast cancer which is triple-negative breast cancer which accounts for about 10 percent of breast cancers, the most exciting development there clearly in the last year or so is the realization and the demonstration in randomized clinical trial that we can improve outcomes for those women if we give them not just chemotherapy but also chemotherapy combined with immunotherapy and specifically the immunotherapy agent called pembrolizumab or Keytruda. 

So, up until a year or two ago, the standard for a stage I or II or III triple-negative breast cancer was to get a multiagent chemo regimen and chemo was really the only type of option we had to treat those triple-negative breast cancer patients and now we know from a major important clinical trial called Keynote 522, that if we take a standard chemo backbone and add Pembrolizumab immunotherapy onto it, that we can help those women do better in the long term. So, that’s really a pretty new in the last one or two years standard of care for triple-negative breast cancer. 

And I guess the last thing I’ll say is not about one of those three subtypes of breast cancer but specifically for women with a BRCA1 or BRCA2 mutation associated with their breast cancer, which is a minority. It’s about 5 percent of breast cancer patients. Obviously, the proportion changes depending on your subtype of breast cancer and your age when you’re diagnosed, but for women who have a breast cancer associated with BRCA1 or 2 mutation and have a higher risk or early stage breast cancer. 

So, again, they have a number of lymph nodes involved or a big tumor in the breast or something like that, we now know that we can add on one year of the PARP inhibitor medication called olaparib or Lynparza to the postoperative treatment of those breast cancer patients in addition to whatever other treatment they got; the antiestrogen pills, the chemotherapy, or a combination of those two, and with the addition of olaparib or Lynparza for a year that we can again see better long-term outcomes for those patients and help them avoid recurrences. 

So, that’s not a majority of breast cancer patients but is a targeted treatment that we’re very excited about that definitely makes an important contribution to reducing risk for women with a BRCA1- or BRCA2-associated cancer or men for that matter. I’m saying women, but it could absolutely apply to men. 

How Is Metastatic Breast Cancer Treated?

How Is Metastatic Breast Cancer Treated? from Patient Empowerment Network on Vimeo

Breast cancer expert Dr. Adrienne Waks discusses treatment approaches for metastatic breast cancer and explains how research is evolving.

Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.

See More from Thrive Breast Cancer

Related Resources:

What Role Do Breast Cancer Patients Play in Care and Treatment Decisions?

Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial

What Are the Treatment Options for Early Stage Breast Cancer?


Transcript:

Katherine:

What about people who have metastatic disease? What treatment advances are available for them?  

Dr. Waks:

Yeah. You know, I think that’s an incredibly important question and a totally different set of discussions than we have with women with early stage breast cancer and unfortunately and unacceptably at this point for a woman diagnosed with metastatic breast cancer still typically that can become a life-threatening diagnosis. 

So, it’s exceptionally important that we rapidly improve the treatment options that we have for women with metastatic breast cancer. Maybe everybody says this every year, but I think that this year, 2022, has been a particularly exciting year in terms of advances that we’re making in the treatment of metastatic breast cancer, really of all subtypes. I would say the most exciting class of drugs or type of drugs that’s coming out in breast cancer and in all malignancies honestly, is called antibody drug conjugates, which is to say an antibody. So, a molecule that’s targeted to some particular approaching on a cancer cell surface and then is attached to or conjugated to a chemotherapy molecule.  

So, the antibody is like a smart delivery system directly to the cancer cell for what’s call a payload, basically like a sort of action molecule or the killer molecule, which is the chemotherapy. 

Those kinds of antibody drug conjugants have made a huge impact in recent years in improving outcomes for women really with all subtypes of breast cancer, so that drug class I think is a very exciting one to watch in general. In terms of specific recent developments in metastatic breast cancer, so probably the biggest blockbuster development over the past year and really over just the past three months is the understanding that we can break out a subtype of metastatic breast cancer that we really didn’t even talk about before which is called HER2-low breast cancer. So, before if you asked me in May of 2022, there really were only two types of HER2 readouts for a breast cancer tumor. 

There was a HER2-negative breast cancer tumor and there was a HER2-positive breast cancer tumor and as I already told you, the HER2-positive accounts for about 20 percent of breast cancers overall. The other 80 percent are HER2-negative. And so, historically, again you asked me three months ago I would have said if you’re HER2-positive and that 20 percent will give you these different HER2-directed treatments and if you’re not, we can’t use those. And what’s changed is that we’ve developed new antibody drug conjugants. So, drugs that are targeted against in this case the protein HER2 that seem to be so effective and work so well, that you don’t truly have to be HER2-positive.  

You can be HER2-low and still benefit from these treatments, which is to say your cancer has a little bit of HER2 protein on the surface of the breast cancer cells but not a lot. So, not enough to make it positive but enough to make it low in its designation. 

That’s actually a large proportion of breast cancer patients. It’s over 50 percent of breast cancer patients, so it’s significantly more than HER2-positive, so a large proportion of breast cancer patients actually fit into this new category called HER2-low and we now know from data that were presented in June of 2022 and then published in the New England Journal of Medicine, which is our biggest most high profile academic medical journal, we know that for patients who fall into that HER2-low category, again that’s more than 50 percent of breast cancer patients, that they can, if they have a metastatic breast cancer, benefit from this new antibody drug conjugate called trastuzumab deruxtecan (Enhertu).  

When it was compared to the existing chemo options we have for those patients which do have some efficacy but nonetheless, when trastuzumab deruxtecan was compared to the existing chemo options, it clearly looked better for patients with HER2-low breast cancer. So, that was not just an exciting advance in terms of new treatment options which we always love to be able to offer to patients but also in terms of breaking out this entirely new designation and subcategory that captures more than half of our metastatic breast cancer patients and helping us to offer them something new and hopefully will be a pathway for other drugs to be developed in this space and for this new subcategory. 

So, that was very exciting. I’ve been talking about it with patients all the time in the past just three months since those data came out.  

You know, a second antibody drug conjugate that has also been very exciting in recent months and recent years is called sacituzumab govitecan which Trodelvy is the brand name of that one. That’s an antibody drug conjugate that’s targeted against a different protein on the cell surface that’s targeted against the protein Trop-2, so that’s where the Trodelvy comes from. It’s targeting Trop-2. That’s an antibody drug conjugate that we’ve known for probably three or more years now can be very effective in triple-negative metastatic breast cancer. So, we’ve had that option for a number of years in metastatic triple-negative breast cancer. 

But again, just in the past few months have gotten good and exciting data that this Trodelvy or sacituzumab drug also works in estrogen-driven breast cancers.  

And so, it’s giving another option to patients with not just triple-negative but also estrogen-driven breast cancer. So, that was another very recent development just in the last three months or so. 

Katherine:

That’s really exciting. 

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.

See More from Clinical Trials 101

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A Patient Shares Her Clinical Trial Experience

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

Are Clinical Trials a Logistical Nightmare?


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. 

What Are the Risks and Benefits of Joining a Clinical Trial?

What Are the Risks and Benefits of Joining a Clinical Trial? from Patient Empowerment Network on Vimeo.

Why should a cancer patient consider a clinical trial? Dr. Pauline Funchain of the Cleveland Clinic explains the advantages of clinical 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.

See More from Clinical Trials 101

Related Resources:

You’ve Chosen to Participate In a Clinical Trial: What Are Next Steps?

Understanding Common Clinical Trial Terminology

How to Find A Clinical Trial That’s Right for You


Transcript:

Katherine Banwell:

Why would a cancer patient consider participating in a clinical trial? What are the benefits? 

Dr. Pauline Funchain:

So, I mean, the number one benefit, I think, for everyone, including the cancer patient, is really clinical trials help us help the patient, and help us help future patients, really.  

We learn more about what good practices are in the future, what better drugs there are for us, what better regimens there are for us, by doing these trials. And ideally, everyone would participate in a trial, but it’s a very personal decision, so we weigh all the risks and benefits. I think that is the main reason.  

I think a couple of other good reasons to consider a trial would be the chance to see a drug that a person might not otherwise have access to. So, a lot of the drugs in clinical trials are brand new, or the way they’re sequenced are brand new. And so, this is a chance to be able to have a body, or a cancer, see something else that wouldn’t otherwise be available.  

And I think the last thing – and this is sort of the thing we don’t talk about as much – but really, because clinical trials are designed to be as safe as possible, and because they are new procedures, there’s a lot of safety protocols that are involved with them, which means a lot of eyes are on somebody going through a clinical trial.  

Which actually to me means a little bit sort of more love and care from a lot more people. It’s not that the standard of care – there’s plenty of love and care and plenty of people, but this doubles or triples the amount of eyes on a person going through a trial. 

Katherine Banwell:

Yeah. When it comes to having a conversation with their doctor, how can a patient best weigh the risks and benefits to determine whether a trial is right for them? 

Dr. Pauline Funchain:

Right. So, I think that’s a very personal decision, and that’s something that a person with cancer would be talking to their physician about very carefully to really understand what the risks are for them, what the benefits are for them. Because for everybody, risks and benefits are totally different. So, I think it’s really important to sort of understand the general concept. It’s a new drug, we don’t always know whether it will or will not work. And there tend to be more visits, just because people are under more surveillance in a trial.  

So, sort of getting all the subtleties of what those risks and benefits are, I think, are really important. 

Katherine Banwell:

Mm-hmm. What are some key questions that patients should ask? 

Dr. Pauline Funchain:

Well, I think the first question that any patient should ask is, “Is there a trial for me?” I think that every patient needs to know is that an option. It isn’t an option for everyone. And if it is, I think it’s – everybody wants that Plan A, B, and C, right? You want to know what your Plan A, B, and C are. If one of them includes a trial, and what the order might be for the particular person, in terms of whether a trial is Plan A, B, or C. 

How Can Clinical Trials Be Accessed?

How Can Clinical Trials Be Accessed?  from Patient Empowerment Network on Vimeo.

Clinical researcher Dr. Seth Pollack and patient advocate Sujata Dutta explain the benefits of participating in a clinical trial. They review important questions to ask your doctor and share advice for finding a trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

What Is a Clinical Trial and What Are the Phases? 

Are Clinical Trials Safe?

A Patient Shares Her Clinical Trial Experience


Transcript:

Katherine Banwell:    

Sujata, there’s clearly a lot of hesitation and misconceptions out there. What would you say to someone who’s considering a trial but is hesitant?

Sujata Dutta:  

I would say speak to your provider, speak to your doctor, and get all these myths kind of busted to say, “it’s going to be expensive” or whatever those questions are. And then, through that process also try and understand what is it that the study is trying to achieve? How is that going to be beneficial to you? So, in my instance, it wasn’t the last line of defense, it was just one of the processes or combos that would help me. And so, that was important for me to understand and then a little bit of education as well. So, I was asking, I have questions on my phone every time I meet my provider, and I did the same thing. So, I think that one of the good practices is keep your note of your questions and have those questions ready. And no question is silly, all questions are important. So, ask as many questions as you can and use that opportunity to educate yourself about it.

And maybe you realize, “No. I don’t think it’s working for me” or “I don’t think this trial is good for me.” But it’s good, important, to have that conversation with your provider, that’s what I would recommend highly.

Katherine Banwell:    

Excellent. Thank you, Dr. Pollack, if someone is interested in participating, how can they find out about what trials are even available for them?

Dr. Seth Pollack:       

Yeah. I mean, the best thing to do is to start just by asking your doctor if they know about any clinical trials. And a lot of the times the clinical trials are run at the big medical centers that may be closer to you, so you could ask your doctor if there’s any clinical trials at the big medical center even. Or I always think it’s good to get a second opinion, you could go get a second opinion at the big medical center that’s close to you and ask them what clinical trials are at your center.

And sometimes they’ll be conscious about some of the clinical trials that may be even run around the country. And you can ask about that as well.

Katherine Banwell:    

Would specialists have more information about clinical trials than say a general practitioner?

Dr. Seth Pollack:       

So, I specialize in rare cancers, so a lot of the times the general practitioners they’ve got my cell phone number, and they text me, and they say, “Hey, do you have a clinical trial going on right now?” And that happens all the time, but yeah, the specialists will usually because frankly there’s so much to know. And the general practitioners really have a lot to keep track of with all the different types of diseases that are out there. Whereas at the big centers, the specialists, part of their job is really to keep their tabs on what’s going on with the clinical trials.

So, they’re good people to ask, either your local doctor could reach out to them, or you could go get a second opinion and ask.

Sujata Dutta:  

There’s also a lot of information, Katherine, on sites such as LLS, or PEN, or American Cancer Society that they also publish a lot of information. Of course, I would recommend once you have that information then vet it by your specialist, or whatever. But if you’re interested in knowing more about clinical trials in general and some that would work for you, then those are also some places to get information from.

Katherine Banwell:    

That’s great information. Thank you, I was going to ask you about that Sujata. Well, before we end the program, Dr. Pollack, I’d like to get your final thoughts. What message do you want to leave the audience with related to clinical trial participation?

Dr. Seth Pollack:       

Yeah. I think clinical trials it can be a very rewarding thing for a lot of patients to do, I think patients really like learning about the new treatments. And I think a lot of patients really like being a part of pushing the therapies forward in addition to feeling like sometimes they’re getting a little bit of an extra layer of scrutiny, because there’s a whole extra team of research coordinators that are going through everything.

And getting access to something that isn’t available yet to the general population. So, I think there’s a whole host of advantages of going on clinical trials, but you need to figure out whether or not a clinical trial is right for you.

Katherine Banwell:    

Yeah. Sujata, what would you like to add?

Sujata Dutta:  

Absolutely, I second everything that Dr. Pollack is saying. And in my personal experience I wouldn’t say everything is hunky-dory, everything is fine. I’m going through treatment, I have chemo every four weeks, I started with chemo every week. That’s when the logistics pace was really difficult because going to Mayo every week was not easy. But anyways, as the trial progress itself every four weeks, but as I said the benefits are huge because I have labs every four weeks. I meet my provider every four weeks.

So, we go through the labs and anything amiss, I’ve had some changes to my dosage because I’ve had some changes in the labs. And so, there’s a lot of scrutiny which I like, but the flip side, for maybe some maybe like, “I have to have chemo every four weeks. Do I want to do that or not?” Or whatever. In my case, I knew it, and I signed up for it, and I’m committed to doing that for two years. And so, I’m fine with that. So, I would say all in all, I’d see more benefits of being in a clinical trial. One, you’re motivated to give back to the community. Two, you are being monitored and so your health is important to your provider just as it is to you. And so, I highly recommend being part of a trial if it works for you and if you’re eligible for one.

Are Clinical Trials Safe?

Are Clinical Trials Safe?  from Patient Empowerment Network on Vimeo.

Clinical researcher Dr. Seth Pollack explains the safety protocols in place for clinical trials, including how data is reported and protected. Patient advocate Sujata Dutta goes on to share her experience in a clinical trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

A Patient Shares Her Clinical Trial Experience

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?


Transcript:

Katherine Banwell:

Some patients feel that clinical trials aren’t safe, is that the case, Dr. Pollack?  

Dr. Seth Pollack:

No. I mean, we go through, as I was saying before, these clinical trials are extensively vetted. So, the safety is, of course, one of the things that we look most carefully about. But as I was saying before, like with any treatment’s cancer treatments have toxicity, that’s a common problem. So, and when you’re dealing with something brand new sometimes there is a little bit more risk. So, when you’re talking about these very early-stage Phase I trials you probably want to talk to your doctor about what sorts of toxicities you can expect and where they are in the Phase I trial. Are you the first ever to receive this new drug? And if you are nobody’s making you go in the clinical trial, so it can only help to get more information. Right? So, you should ask your team about it, you should find out. 

Most of the time there’s going to be a lot of patients that have been treated already, I mean, they can’t give you definitive data about how things are going but they can maybe say, “Hey. I’ve already treated a few patients on it, and they seem to be doing great.” 

Katherine Banwell:

So, you need to weigh the pros and cons of the trial. 

Dr. Seth Pollack:

You do need to weigh the pros and cons. Now, when you’re talking about these Phase IIs and Phase IIIs, I mean, these are drugs now that have really been vetted for their safety and we have a lot of data about it. And even the Phase Is, it’s not like these things are coming out of nowhere, they’ve been scrutinized, we really expect that they’re going to be safe but we’re doing the trial to prove it. So, it’s a good thing to ask about. 

Katherine Banwell:

Yeah, yeah. 

Sujata Dutta:

Yeah. I would also add that it’s so closely monitored that safety is a top priority, it’s front and center. So, the advantage, I think, with being on a trial is the close monitoring of the patient exactly for this reason. 

If something is amiss it’s going to be picked up as quickly as possible and you’re any issues are going to be addressed as soon as. So, I think, safety does get addressed pretty quickly.  

Katherine Banwell:

Good. 

Can data from trials even be trusted? Dr. Pollack, is that the case? 

Dr. Seth Pollack:

Well, of course, I mean, it can be trusted. Because the thing with the clinical trial data is that you really see the data and there’s all kinds of scrutiny making sure that the data is reported accurately. Now, there’s a whole other conversation we could have as to whether we could interpret the data differently. And sometimes that is an issue that comes up, but the data is reported very accurately. 

So, and there are statistics that are very well understood, and the bar is actually pretty high to say one arm of the trial was better than the other arm of the trial. So, if patients have better survival on one arm, if we say that, usually it means they did considerably better. Enough better that it wasn’t a random chance that one extra patient did better on the treatment arm. No. There were enough patients that did better that the statisticians can go through it with a fine-toothed comb. And they can be absolutely sure up to exactly how many percent sure they can tell you, 0.05 percent or less chance of error that this was a real difference between the study arm and the standard of care arm. 

Sujata Dutta:

I think you mentioned too that one is trust, and one is data. So, Dr. Pollack mentioned a lot about the data, I think the trust is also a very important thing. I like to go with positive intent because I do not have a reason to believe my doctor has some ulterior motive to suggest a clinical trial. And so, I trust them wholeheartedly. The first hurdle is you have to trust the system or what is being proposed to you because, as Dr. Pollack said, it’s gone through a lot of vetting. A recommendation to be part of a trial itself is vetted by your doctor when they make the recommendation. So, have faith, trust, that they are making a good recommendation. And then, of course, the data, I don’t know much about that, but as I said, I trust it. So, I would trust the data too. 

Katherine Banwell:

Of course. Of course. Some patients feel like they’re going to lose their privacy. Sujata, did you feel that at all? 

Sujata Dutta:

No. Not at all. 

I mean, with everything else that is also taken care of, my information, or whatever, is not made available to anybody. And so, obviously there’s a lot of people will get those, and I had a huge pile of paperwork to go through, but I think that’s a good thing. For my peace of mind that I knew that my information was not going to be shared outside of the study, the trial, etc., and things. So, no, I don’t think that’s a problem. 

Katherine Banwell:

Beyond these misconceptions is there anything else you hear? Dr. Pollack?  

Dr. Seth Pollack:

No. I mean, look, in our crazy modern world there’s concerns everywhere, but the clinical trial is very, very careful. Whenever possible we use the medical chart.  

And then, we have a very stringently protected database that’s storing people’s information, but it’s deidentified. So, I mean, we have a separate key to figure out who the patients are and then we try to limit the use of the patient’s name or any identifying information about them beyond that. So, and your information is not shared. For example, if there’s a drug company involved in the trial, your information is not shared with the drug company, you have a new identifier that is unique and not traceable back to you that is provided to whoever, if there’s outside groups working on the trial with you. So, your information is very carefully protected, and everyone is very conscious about issues regarding privacy.  

Katherine Banwell:

That’s great to know.  

Are Clinical Trials a Logistical Nightmare?

Are Clinical Trials a Logistical Nightmare?  from Patient Empowerment Network on Vimeo.

PEN board member and myeloma survivor Sujata Dutta shares how her family managed the logistics of her clinical trial participation.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

Are Clinical Trials Safe?


Transcript:

Katherine Banwell:    

The logistics will be a nightmare and I don’t live close to a research hospital. Sujata, did you have that issue?

Sujata Dutta:  

Yeah. That’s a very interesting one, and actually I’ll share my experience. I did have this concern about logistics, because I got my transplant at Mayo Rochester, which is a two-hour drive from where I live. And so, when I got to know about it literally me and my husband were like, “Oh, my gosh. What are we going to do?” It’s not just me, my husband is my caregiver, he has to take the day off to drive me to Mayo, wait through my treatment, and drive me back. Then we have boys who were distance learning at the time, and so what do we do with them? Do we drop off a friends or take a favor from a friend? And so on and so forth.

So, the logistics was an issue and we literally said, “Thanks but no thanks” and we walked out of the room. And we came downstairs, and my husband was like, “What the heck?” My team understands everything, and I fortunately work for a very good employer, and they understand everything, people first. And so, he was like, “I can figure this out. Let’s do it if this is what’s going to help you, then let’s just figure this out.” And at that time, it was so good, and I have total respect for Dr. Pollack.

You and everybody in this medical community. My doctor who leads the trial at Mayo, she actually said, “Why don’t you check with your local cancer center? Maybe they are also approved by FDA, and they may be able to administer this treatment to you.” Unfortunately, at that time they weren’t but we were like, “We’re going to go ahead with the trial. It doesn’t matter.” My husband was like, “I’ll take the day off, you don’t worry about it.” And then, four months later my institute did get approved by FDA, and so I was able to transfer from Mayo to my local cancer center, Abramson Cancer Center, which is 20 minutes from home. And so, there are options, I know that it can be an issue and it can be overwhelming at the time which was the case with me. But I was able to overcome that, so maybe there are options available that the patients can consider.

Is It Expensive to Participate in a Clinical Trial?

Is It Expensive to Participate in a Clinical Trial?  from Patient Empowerment Network on Vimeo.

Is there a financial cost to participating in a clinical trial? Dr. Seth Pollack explains how clinical trials participation is billed and potential financial impacts.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Is this fact or fiction; it will be expensive? Dr. Pollack?

Dr. Seth Pollack:       

That’s fiction because the way the clinical trials work is we go through everything very carefully to figure out what things are standard and what things are unique to the clinical trials. So, if you are getting chemotherapy, you’re going to need blood work, you’re going to need the chemotherapy drugs, you’re going to need some sort of imaging, CT scan, or whatever your doctor would do.

And all those sorts of things are considered standard, so your insurance company is built for those. Then there’s a bunch of things that are considered research. For example, there’s special research bloodwork, maybe there’s an investigational agent that’s being added to standard chemotherapy. Those things are billed to the study, so you don’t actually have to pay anything extra, it’s just like you’re getting the normal treatment as far as you’re concerned. I mean, that’s the way it always is, and I haven’t had any of my patients ever get into real problems in terms of the finances of these things. It always works very straight forward like standard therapy.

Is a Clinical Trial a Last-Resort Option?

Is a Clinical Trial a Last-Resort Option?  from Patient Empowerment Network on Vimeo.

Are clinical trials only meant as a last-resort option? Dr. Seth Pollack debunks this common clinical trial misconception and explains why he feels patients should participate when the opportunity arises.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Right. And another concern that people have is; clinical trials are my last resort treatment option. What do you say to that Dr. Pollack?

Dr. Seth Pollack:       

Yeah, no. That’s a common misconception. So, we like to have clinical trials for every phase of the patient’s cancer journey because we’re trying to make every single part of the cancer journey better. So, I think a lot of people think that, okay, when they hit their last resort that’s kind of the time to try something new. Even in the very earliest parts of the cancer journey, even in the diagnosis phase sometimes we’ll have clinical trials where we’ve tried different images, modalities, or look at things in a different way in terms of the biopsies.

But then, in terms of the cured-of treatments, when somebody is in the cured-of setting we don’t usually try something very brand new. But a lot of the times we’ll try something that is very affective for patients at the end, and we want to try and make the cured-of strategy even better. So, a lot of the times for those patients we’ll have new therapies that are very safe and established that we’re trying to incorporate earlier into patients’ treatments because we know they work really well, right? And then, even in patients who have incurable cancer a lot of times it’s better to try a clinical trial earlier on just because sometimes the clinical trials have the most exciting new therapies that are bringing people a lot of hope.

And a lot of the times you want to try that when you’re really fit and when you’re in good shape. So, that’s why I think that you really want to think about doing a clinical trial when the opportunity arises.

Katherine Banwell:    

Yeah. Beause it could be beneficial to you and it’s certainly going to be beneficial to other people.

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?  from Patient Empowerment Network on Vimeo.

Does participating in a clinical trial make you a “guinea pig” for new treatments? Clinical researcher, Dr. Seth Pollack, provides a clear explanation of clinical trial safety protocols.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Well, I’d like to address a list of common concerns about clinical trials that we’ve heard from various audience members prior to this program.

And this is probably the most common; I will be a guinea pig. Dr. Pollack, how do you respond to that?

Dr. Seth Pollack:       

Yeah. I know that is a common concern. I mean, I think the thing that people have to understand about clinical trials is there is just so much oversight that happens for these clinical trials. Every document, every procedure, is scrutinized by multiple committees. There’s a scientific review committee, there’s a review board, IRB, that reviews these. Many of these trials are reviewed by the FDA and they’re reviewed by your doctor and your doctor’s colleagues that are also participating in the trial. So, every detail is discussed at length.

In fact, a lot of the times there’s a lot more structure to being on the clinical trial than just routine clinical care because they’ve thought so thoroughly about when everything needs to be done and what the right timing of is for the various procedures.