|
Slide #1
GISELLE SAROSY: Thank you very much. I'd like to thank the Lymphoma Research Foundation for inviting me here today. What I'm going to do in the next half hour is give an overview of how you can use the internet to find clinical trial information. I'd like this to be as interactive as possible. Again, it'll be sort of an interesting presentation, because parts of it I'll simulate what it's like to be on the internet, although I won't actually be on the internet. But if something -- if as I'm going through this presentation, if you have any questions or you're confused or unsure of what I'm saying, feel free to interrupt at that time, and we're going to allow some time at the end of each of our sessions for questions.
When one goes about trying to become savvy about clinical trials, I know you have questions. Among them are, how do I find the best treatment for my disease? Is a clinical trial a right thing for me? So then you start looking around. Who do you ask questions of? Who do you call, or where do you go on the internet? And one of the things that you probably are aware of is the National Cancer Institute provides several avenues to try to find -- to try to provide answers to your questions. The first is the cancer -- the NCI's cancer information service. The number is 1-800-4CANCER, and the second is a website called cancer.gov, which contains a great deal of information that is used by the people at the NCI's Cancer Information Service. If there is nothing else that you take away from my part of the session, it would be to remember these two things, the phone number and this URL.
When one goes to the internet, one can either go to trusted sites -- and in my presentation I'll go over aspects of what one can consider when looking at a new site to decide whether it's trusted or not -- or simply searching the internet.
This is the home page of NCI's website, cancer.gov, and it was redesigned approximately a year ago, and we're now in about our tenth month. Our audience is everyone in the American public, including health professionals, patients with cancer, those who care for patients with cancer, those who are doing basic science research. And the two areas that you'll probably be most interested in looking at would be the area about cancer information, and this was the website that was previously called Cancer Net, for those of you who might remember that website, and Clinical Trials, which was the website previously called Cancer Trials. What we tried to do was integrate all the information as much as possible and make it as easy as possible for anyone interested in cancer information from the NCI to find the information they need.
What I thought would be helpful would be if, let's say, you came to this website -- and again, I'm not on the internet, so I can't do this interactively, but I can show you some of the paths to the information that I've decided to try to show you today. Let's say if you want information about lymphoma, you could either navigate it from the cancer information area, or you could type "lymphoma" in the search area. I apologize. These letters are probably pretty small for those of you in the back of the room, but feel free to come up closer, and I'd be happy to show you this in smaller groups afterwards or other breaks during the session.
But if you type in "lymphoma" and hit "search," you'll come to a list of hits from that search in your search retrieval, including as the first retrieval the Lymphoma Home Page, which clusters in one area all the information, or a great deal of the information, that NCI has that would be of interest to someone who is looking for information about the treatment of lymphoma. I have a question.
MALE SPEAKER: [Inaudible]
GISELLE SAROSY: The question is, the Lymphoma Home Page is the Lymphoma Research Foundation Home Page. The answer is no. Since this is the cancer.gov, the NCI's website, the next page, this is the Lymphoma Home Page. It's the home page, or the starting point, of all clinically relevant lymphoma information on this website. What it will have is, it will give you an overview of what you need to know about lymphoma, and will have an area of treatment information.
Could I see how many people have heard of PDQ or know of PDQ? Okay, it looks like quite a few of you. PDQ is a cancer information resource that began almost 20 years ago when personal computers were first becoming widely available, and it has two sources of information that are very helpful for someone who's looking for cancer information: the treatment summaries, which are reviewed and updated monthly by experts in the field, in this case lymphoma experts and medical oncologists who specialize in lymphoma and other areas relevant to lymphoma, as well as a database of clinical trials called PDQ.
So let me show you first of all, if, let's say, you were coming here and you were new to the field of lymphoma, where would you start? One possibility would be to start at the very first document, "What You Need to Know about Non-Hodgkin's Lymphoma." And this shows you the first page of that document, and much of what I'm showing you in terms of where it is on the web and how you can find it, Sheila will talk about in greater detail. But this is an overview of what non-Hodgkin's lymphoma is, and as you can see, a lot of the terms are hyperlinked to the definitions in a glossary, which is also updated and maintained each month. Again, the terms reviewed, updated and maintained. One of our guiding principles is continuously reviewing, updating and maintaining this information.
If you went back to the home page, you would find the PDQ treatment information in this area, and these statements are in two formats, the highly technical version written for health care professionals, and a consumer-oriented version of the same information. And you would also find on the bottom of this page information that is relevant to a lot of people who are dealing with cancer in terms of how to deal with side effects, nausea and vomiting, depression, et cetera, and complementary and alternative medicine.
However, one of the things that this session is really about is how do you find clinical trials on the web? How do you find them? How do you assess the quality of them? Where do you go for additional information? So let's say you wanted to search for clinical trials. You could search right there, and this would bring you to a search form. The search form that I'm showing you is the current search form on cancer.gov, the PDQ search form. But I should tell you that this will look like this only for about another month or two. PDQ, as I mentioned earlier, has been around for almost 20 years, and it's been in a process of evolution in the past year or two with new technology and with the new searching capabilities and interface design. So within the next two months, we're hoping to present a more streamlined interface to this information, and over the next -- within the foreseeable future, probably introduce an interview-style interface to this information to make it even easier for people to use.
That having been said, if one went there today, for the sake of argument, if you go to the first box, you have a pull-down list of various diagnoses, and for sake of argument I said, let's say you're looking for a trial for somebody with adult non-Hodgkin's lymphoma and you wanted a treatment trial, not one of the prevention of non-Hodgkin's lymphoma or the screening of non-Hodgkin's lymphoma, but a clinical trial that was looking for a new kind of treatment. And since we're in Los Angeles, I've decided to put in Los Angeles and California for the geographic area that I was interested in.
The second part of the search form allows you to more clearly, more precisely refine the results of your search. So what I did here was that I limited the retrieval to -- actually, what I did was the second one, contiguous stage II adult diffuse mixed-cell lymphoma. I didn't refine by modality, but again, if there was a specific type of trial you were interested in, you could do that from that menu. And we've heard a lot about phases of trial earlier today. If you wanted to limit your trial to a specific phase, you could do it in this area also. And if you wanted to limit your trial to a certain, specific type of trial, whether it be NCI-sponsored or pharmaceutical study, you could do so here.
In Los Angeles, California, as of today there are two clinical trials listed in PDQ and distributed through NCI's cancer.gov website for contiguous stage II diffuse large-cell lymphoma, and these include a phase II trial here and a phase III trial here. If you elect to get more information about the initial trial, this is the health professional version of that trial, and it has -- it shows you who's sponsoring the trial, and this is both an NCI cooperative group trial and an NCI-sponsored trial, and it includes quite a bit of information, including the objectives of the trial, who's eligible, and the participating organizations. Again, this is written in fairly technical language, but it has the contact information.
But let's say you wanted to look at the more consumer-oriented version. You would click the patient tab, and you would find very similar information. Again, there are hyperlinks to the technical terms that are described in this abstract.
If you were to go back and say, "All right, now I think I might be interested in a clinical trial, but I want to know more about it," if you click the clinical trial tab at the top of the website, you come to a whole universe of information that may be of interest, including what -- understanding a clinical trial, what it is, recent developments, newly published findings in clinical trials, clinical trial results, which include recent sound bites, and newly published articles about clinical trials. And again, you'd have a way to find a clinical trial.
The area here is directed primarily to clinical trial researchers and provides them with the information regarding the rules, the regulations, the paperwork, the monitoring, and even how to go about -- let's say somebody new in the field is interested in starting a clinical trial. This is an area where they'd be able to go to find more information.
The area in understanding I've shown you so you get some sense of the type of information that is in it. It really talks about what is a clinical trial, has a link to a clinical trials education series that the NCI has developed, and really discusses a lot of issues that somebody new to clinical trials would be interested in, including what is randomization and questions and answers about clinical trials. It also has an area explaining the science of clinical trials. What is angiogenesis, what is the immune system, et cetera.
Moving away from the NCI's website, I think it would be helpful to get a perspective of how much information there is on the internet, and it's hard to believe that ten years ago we didn't have World Wide Web access and we didn't have the source of information. That sometimes is mind-boggling to me to think just how much is there. And I recently did a search of the Google search engine, and I typed in the word "lymphoma," came up with 462,000 hits. I typed in the words "clinical trials" and I found 1,430,000 hits.
Well, when you're new to the field and you're faced with that much information, where do you start? And when you start going through that list, what's credible, what's to be believed and what's not?
We've developed a fact sheet that is posted on the NCI's website that discusses some of the issues that you should consider when looking at this information. When you start looking at the vast number of sites, these are some things to consider when you're looking at the information: What is the purpose of the site? Is it run by a nonprofit or a governmental organization to provide information, or is it done by a single individual to promote his or her own idea, or is it run by a commercial entity that's trying to sell something?
Who pays for the site? Again, that's an important thing to think about when you're looking at one of these multiple sites. What is the source of information? As I told you in the NCI's website, cancer.gov, a core of its information is information from PDQ's Cancer Information Database, which is peer-reviewed, updated monthly, doesn't represent one person's opinion, doesn't represent one expert's opinion, but represents a synthesis and evidence-based collection of that information.
How is the information selected? Again, is there a bias towards one opinion or one commercial entity, or is it well-balanced? How current is the information? And I encourage you when you're looking at web content to see the date when it was last reviewed or last updated. If it was last reviewed in 1999 and last updated in 1999, then that information may not be as helpful and as credible as something that was last updated in 2002.
And then very importantly, what information does the website collect about you and why, because you really want to make sure that you're not having some other computer collecting information about you that you don't want collected.
And then I thought it would be helpful -- I've really spend most of my time talking about where I work and what I do and what we provide to the American public through the NCI's cancer.gov website, but there's a variety of cancer clinical trial websites out there, and I have not attempted to make a comprehensive list, but I have listed some of the ones that do exist, including OncoLink -- that's sponsored by the University of Pennsylvania -- Hope Link, Center Watch, Emerging Med, and what I should point out to you is that many of these use as the source of their information NCI's PDQ database. They frequently provide a different way of getting to that clinical trial data. That is, they may have an interview-style interface, as in Hope Link and in Emerging Med, and they may have some trials that are not found in PDQ, but ultimately most of what most clinical trial websites have as the core of their information is what the NCI provides.
I would also want to point out that NCI's database, a lot of people sometimes say, "Well, it's just NCI trials," and it's not. It's approximately 60% NCI-sponsored trials and approximately 40% other trials -- that is, single institution trials, trials from Europe, trials from a pharmaceutical company. Right now, no one source is comprehensive, but what I would recommend to you is that NCI's website, cancer.gov, is a good starting point in terms of both getting information about what are the treatment options for someone with lymphoma, what is information that may be appropriate in terms ancillary care, supportive care, and a good starting point for a list of clinical trials and appropriate contact points. And then one can visit these other sites for, perhaps, additional information, another way to get to that information, and I would again encourage you when you go to those 400,000 or 1.4 million sites to really keep a set of criteria that you use to judge them as you go through.
So I know that I've gone through an awful lot in a short period of time, but I'd like to at this point open the floor for some questions. Yes?
Q: When you go into a clinical trial ... on the financial side of ... do you pay half ... clinical trials ... trials where you pay ...[Inaudible]
GISELLE SAROSY: The question was, there are some clinical trials where you would pay half, some you would pay, some you would pay part of. I'm not really probably the right person to comment on that, because what I do is -- or what we do is provide information about the clinical trials. But exactly how they're funded and who pays what is a different -- is really not information that we provide. We do have information about insurance concerns and issues to be considered when participating in a clinical trial, but I couldn't answer that question directly. Any other -- Yes?
Q: Yes, in some of these -- my wife is in remission for six months. Is there any need to look at clinical trials for ...
GISELLE SAROSY: The question is, this gentleman's wife has been in remission for six months. Is there any need or reason to look at a clinical trial? What I would suggest, I really view that treatment decisions should be made in consultation with the physician and the health care team that's taking care of the patient, so I would sit down and talk to them and say, "What direction should we go in right now in terms of treatment, and is a clinical trial part of that?"
I think there has been a real shift over the past 15 years between the doctor being the one who tells you what to do to the paradigm that we have now where doctors -- and as a medical oncologist myself, I feel very strongly that health care decisions need to be made in partnership with the patient, and the patient, whoever the patient wants to bring into that decision process in terms of loved ones. So I think I'd sit down with the health care professional and say, "What do you think we should do right now in terms of treatment?"
Q: [Inaudible]
GISELLE SAROSY: To be honest, I don't know the answer to that question. I don't have internet access right now. I apologize. I had hoped that I would, because then we would be able to go and research your questions and we could have looked, but maybe later. Can you hear me now? Okay.
Q: [Inaudible]
GISELLE SAROSY: The question is, is there any way to -- is there any move afoot to try to get clinical trials as a treatment option put into the practice of all physicians, and to answer that, I think there's a lot of movement underway to try to increase participation in clinical trials to make it easier for physicians to participate in clinical trials, because, as we all know, physicians have become incredibly busy, and there are a lot of time constraints. There are a lot of barriers to conducting clinical trials. There are barriers to spending the time in a physician-patient encounter to go through all the treatment options thoroughly, including a clinical trial.
So I'm not aware of any movement to, let's say, institutionalize or to mandate it in every physician-patient encounter, but I think there's a lot of effort underway to try to make clinical trials part of the culture, part of something that both physicians and patients -- or physicians think of and bring to patients when they're thinking about making a treatment decision. Other questions? Again, I apologize for not having been able to get on the web, because I was hoping to be able to go and show you these things, because actually, interacting with the web and doing it can be a lot more alive than just talking about it.
Let me see a show of hands. How many people actually surf the web to find information? So it looks like virtually all of you. And so are there any other issues that you -- Okay, I see another --
Q: I'm just wondering, after you find the possibilities for a trial on the internet, what is the procedure? What are the steps you can take? I'm from Canada, so ... what the trials are in different cities ...
GISELLE SAROSY: Okay, the question is, once you've found the information on the internet regarding a clinical trial, what would be your next step? My suggestion would be to go and talk to your health care provider, your physician, and say, "Okay, here are the clinical trials that I've found that I think might be helpful for me. Let's talk about them. Which ones would you recommend? Which ones not? Which ones can I get at, given the health care system I'm in?"
Again, I feel very strongly that you need to feel comfortable and need to be able to partner with your health care professional and as a team make decisions that make sense for you.
Q: ... the time issue ...
GISELLE SAROSY: The question is, there's a time issue in terms of the encounter?
Q: Yes. There's so much information that ... selection yourself. You can't bring everything that you've found to the doctor. So ... do the selection yourself.
GISELLE SAROSY: The question -- Oh, go --
Q: [Inaudible]
GISELLE SAROSY: Yeah, the question is, when you have -- there's so much information, and there's really not enough time with your physician to have him or her work with you to pick out the clinical trial that's good for you. How do you make the decision as to which one is relevant?
I think if one is interested in clinical trials, one can do a couple of things. One is to get as much information as you can about your disease in terms of what's the diagnostic name of it, what is the stage, have you had previous treatment, and then call -- If you perhaps call 1-800-4CANCER and talk to one of the trained information specialists there to help point you in the right direction of what trials might be appropriate.
Okay, I understand that we're now technically where we need to be for Sheila to start her presentation, because I think her presentation will cover some of the questions that have now been coming up.
Slide #2
SHEILA BRESLIN, RN, MS: Hi. It's nice to see so many of you here. What I hope to do in the next 25 minutes or so is to give you some insight or tips, maybe addressing some of the unanswered questions about how to be a savvy clinical trials participant. I actually would like to share with you that I say insider tips because not only am I a clinical trials research nurse, but I'm also a cancer survivor and a clinical trials participant.
Slide #3
So you've already heard about some of the information you can get on the web. There are also some booklets that you can get. This is one, "Taking Part in Clinical Trials: What Cancer Patients Need to Know."
Slide #4
And another one is called "Taking Part in Clinical Trials: Cancer Prevention Studies." Both of these you can get. Either by calling 1-800-4CANCER or accessing the web at cancer.gov you can order these. These will give you good general overviews of clinical trials, what it means to be a clinical trials participant, what the different phases of clinical trials are, what kinds of questions you should ask.
But actually, as I was preparing this presentation, I learned a lot, and I came across a really good publication from the American Cancer Society that I downloaded. It's called "Clinical Trials: What You Need to Know." This is about 24 pages, much more in depth, and it goes through examples of different phases of clinical trials and what kinds of things to consider. And if you're considering participating in a clinical trial, I would definitely start with the booklets from the NCI, but then I would try and get a copy of this, either downloading it or calling American Cancer Society to see if they can send you a copy. This is really excellent.
Q: {Inaudible}
SHEILA BRESLIN, RN, MS: It's American Cancer Society, ACS. Just call your local chapter of American Cancer Society. Every area has a local chapter, or just type in your browser ACS or American Cancer Society. That's how I found it. It's an excellent piece of literature.
Slide #5
So you've probably learned by now that what you really need to do as a cancer patient is your homework. You all thought you were done with school. You're not done with school if you have cancer, and unfortunately, to some extent, the onus is on us because there are -- The good news is that there's a lot of options. The bad news is that there's a lot of options, in some sense.
Cancer is an overwhelming diagnosis. I speak from personal experience, and you really need nowadays to educate yourself about what's out there, and there are a number of ways to do this. The NCI website is outstanding. Lymphoma Research Foundation has an excellent website, as well. American Cancer Society. Many, many resources for you.
Slide #6
But because it's overwhelming, it's really helpful to have a friend. It's really helpful to have another pair of eyes, ears -- and in this case, whiskers -- to help you sort through the tons of material that's out there to help you learn about your disease and hopefully to make an informed decision about what treatment options would be best for you.
Slide #7
So if you're being told that a clinical trial might be an option for you, you're going to get a document called a consent form, and it can range from three or four pages to as many as 15 pages, but it's going to include some basic information, and I'm going to go over each one of these in more depth with you.
First of all, the consent form is going to include the reason that the study is being proposed and what the objectives of the study are. It's also going to include information on the treatment plan. So what exactly am I signing up for? It's going to talk about potential risks and potential benefits. It's also going to talk about alternatives to participation -- what other options do I have? It should give you information about costs. What specifically will the study pay for? What specifically will be billed to you or your insurance company? How will your confidentiality be protected? And a statement that you have freedom to withdraw from the study at any time. So let's go through each one of these.
Slide #8
First of all, what are the rationale and objectives of the study? So the kinds of things that should be clear after reading the consent form -- which, by the way, is supposed to be written, I think, at the fifth- or the sixth-grade reading level. However, there's not some master person that checks all the consent forms, and I can tell you from experience that this really varies widely from institution to institution. So I always tell my patients to jot down questions that they have in the corner of the consent form as they're reading it through for the first time.
So hopefully this will be explained right in the beginning of the consent form, why do doctors think that this new treatment might be of benefit to me? What backs it up? What kind of prior studies have been done?
What are the specific goals of the study? Is the goal to improve the cure rate? Is the goal to test a new drug and find out what the best dose level is? Are the goals of the study the same as my goals? So if you're reading a consent form and it says the main objective of the study is to test this new drug that's just coming out of the lab to see what the maximum dose that a patient can tolerate is, and your goal is, "I want something that hopefully will give me a long-term remission and a cure," those goals may not mesh. And we'll talk more a little bit about that when I talk about phase I clinical trials.
Why does my doctor think that this study may be of benefit to me? So not why in general may the study be of benefit. Why does my doctor think -- My doctor knows my history, knows the prior treatments I have. Why is this now being offered to me? So where are we now in the decision-making process in terms of my particular disease?
Slide #9
When you're thinking yourself about how likely the study is to be of benefit to you, you want to know what phase the study is -- and we'll talk more about phases in a minute -- whether the study includes randomization to a particular treatment arm, whether there's going to be a placebo involved. It would be a good idea to ask how many patients with your diagnosis and your stage have been treated so far and how they've done, and that's an okay question to ask. If they have results, they are obligated to share them with you. And also it would be interesting to know if results of similar or preceding studies are available, and what are the results?
Slide #10
I know that in one of the last sessions they talked a little bit about the different phases of the study, so I won't belabor this, but I'd just like -- if you're not already aware, before a drug, for example, is FDA-approved, it goes through three phases of clinical studies, and the goals are different, depending on what the phase of the study is. So, for example, for phase I clinical trials -- now, these are -- the very first time, for example, a drug is being tested on humans, they've done a lot of basic science research, and now it's being brought to patients to see if it's going to be useful. The first thing that they're really looking at is what's the safety profile? They know how it affects mice, but they don't know how it really affects humans. So they're going to look at safety and also the maximum tolerated dose. So phase I studies are generally reserved for patients in whom all other therapies have not worked, and they have very limited treatment options. And in these studies, the benefits to each individual patient are really very uncertain. However, certainly the information that's gained will benefit others in the future.
And the phase I studies are tested in lots of different types of cancer, so you may be in a phase I study with someone who's got lung cancer and colon cancer and ovarian cancer and so on, and they're looking to see mainly safety and maximum tolerated dose. Now if, in a phase I study, it looks like a drug has some effectiveness in a subgroup of patients -- so say it's tried in lymphoma, breast, colon, lung, and it looks to have some effectiveness in lymphoma and lung cancer patients, then it will be advanced to a phase II study. Now they know what dose the maximum tolerated dose is, and they're trying to see how effective it is in a particular disease. And in general, at least for an experimental drug, it's for patients who have relapsed after standard therapy. These studies have a better chance of benefitting you personally than a phase I study, obviously, because now they know what the best dose level is.
And then the only way we ever know if a new therapy is as good or better than a standard therapy is to compare it in a phase III study where it's randomized, meaning that you do not have a choice as to which treatment group you're in, and that's the downside of a phase III study. But there again is a better chance of personal benefit in a phase III study.
Slide #11
The next thing you need to understand is the treatment plan. Again, this will be explained in the consent form. Unfortunately, it's never quite as simple as taking one enormous pill and then calling the doctor in four years.
Slide #12
And so the kinds of questions that you want to ask are how long the treatment will last, meaning each individual treatment, the infusion, how many times do I have to come in for it, what tests and procedures are involved, so when do I come in for CAT scans, blood work, how often will they be done? How and when will I know if the treatment is working?
Now, for some drugs it's pretty obvious within a very short period of time whether there is any effectiveness. For other treatments, newer treatments, for example, Rituxan is a good example -- therapies that mobilize one's own immune system, you may not see results for months, or maximum results for months. So if I'm scheduled to have a CAT scan in a month, what if it doesn't show any change? Does that mean it's not working for me? And that depends on the particular study. So for some studies the answer would be yes. For some studies the answer would be no, we don't really expect to see a maximum benefit for six months.
What happens if my disease progresses during this study? Typically what happens is you're taken off the study and offered other options. You would not be kept on a study if your disease was not responding to the treatment. And it would also be important to know how often you'd have to come in for followups and what that would entail.
Slide #13
What are the risks? Well, hopefully, way before you grew this claw you'd be talking to your doctor and talking about side effects, but certainly any therapy has side effects associated with it, whether it's in a clinical trial or not.
Slide #14
So here are some of the risks of participating in a clinical trial. First of all, the new treatment may be less effective than standard treatment, it may have more side effects than standard treatment. If it's a randomized study, you may not have a personal choice as to which group you're in. There may be additional costs associated with the study, which may or may not be covered by your insurance company, and sometimes if you participate in one study you may be excluded from participating in another study, depending on what that study is. For example, when we were doing studies with Zevalin, patients who had had stem cell transplants were excluded from participating in the Zevalin trials, and there are reasons for this, but it's just something to be aware of when you're sort of weighing -- If you have more than clinical trial as an option, if you're weighing one against another, it might make more sense to do one first, and then if that doesn't work follow it by the next available option.
Slide #15
Quality of life. I'm one of those people who believes that quality is more important than quantity. It's a very personal thing, but the kinds of things that you want to think about are, what are the short- and the long-term side effects and how likely are they to occur, and how do they compare with standard therapy? Again, all therapy has side effects, so you want to know how the new therapy may impact your quality of life. If it's going to be more negatively impacted, perhaps, as a possibility, that may enter into your consideration.
Are the side effects temporary or are they permanent? Can I talk to other patients who have participated in this study, and who do I contact in case of problems, and how do I get in touch with them?
Slide #16
If we're talking about drug studies, there are just a few considerations. Sometimes studies involved FDA-approved drugs, in which case it may or may not be approved for your particular type of cancer. We may just be looking at a different combination of drugs, wanting to collect data and then carry it on to a future phase III study. Sometimes if the drug use is not -- if it's considered, quote, "off-label," then that may or may not be reimbursed by your insurance company.
If the drug's experimental, you might want to know how many others have received the drug and what the known side effects are. This should be in the consent form. And in the case of a phase I study, if dose escalation is involved, which it always is, meaning that they enroll patients in groups of three or six, observe the side effects. If they're tolerated, go to the next highest level. This might affect your interest also in participating.
And is there a placebo arm, and if there's a placebo arm, is there an option to, what they say, cross over to the treatment arm if your disease starts -- if your disease doesn't respond. So typically placebo-controlled studies are blinded. The researcher doesn't know what you're getting. You don't know what you're getting. But there are certain parameters for un-blinding the study and either taking you off the study and offering you other therapy or crossing you over to the actual treatment arm.
Slide #17
Now, a word about placebo-controlled studies, because I know this freaks a lot of people out. First of all, placebo-controlled studies are never -- Placeboes are never given if a known effective therapy is available. That would be completely unethical. However, they may be used as part of an adjuvant or prevention study, and a good example of this is vaccine studies after a primary therapy of chemo, for example, or surgery. It's not known at this time whether giving a vaccine is going to improve the outcome, so in that case there may be a placebo arm so that one patient gets a vaccine and another patient gets a placebo vaccine. However, whether or not there's a placebo must be disclosed in the consent form. There's no surprises. Nothing can be hidden. Okay?
Slide #18 41:58
What are the benefits?
Slide #19
The new therapy may potentially be better. It may result in improved remission or cure rates. It may improve your quality of life. Typically when you're in a clinical trial, you're very closely monitored. It's really a team approach, so not only is your physician involved, there may be something called a data safety monitoring board that's reviewing the data. A research nurse is typically involved. Research pharmacy may be involved. And then the other benefit, if you're feeling really altruistic, obviously, is that others will benefit in the future from the knowledge that's gained from the clinical trial.
Slide #20
Now, a lot of consent forms will say you have alternatives, but it doesn't spell them out, and there's a wide variety of ways consents are written, and there are a number of reasons why it may not be spelled out, because, as you've seen, particularly with lymphoma, lymphoma is definitely not just one disease, it's a whole group of diseases, and it might be very difficult to put all of the alternatives in a consent form. But nevertheless you should ask, and you should know specifically what other alternatives are there for me, and how likely your doctor thinks these alternatives may be of benefit to you.
Slide #21
Costs. This is where I learned a lot preparing this presentation. You would want to know what part of the study is covered by the insurance and what part of the study is covered by a grant, specifically. And in March of 2000, the Medicare rules changed. I don't know if you're all aware of this, but for Medicare recipients, all government-sponsored phase II and III trials are now covered by Medicare. At least the routine patient care costs are now covered by Medicare.
And in California, in August of last year, the governor signed into law Senate Bill 37, which mandates coverage of routine patient care costs for any cancer patient participating in any phase clinical trial. Now, this doesn't mean your insurance company can't cover things that it wouldn't routinely cover, but they need to cover things like CAT scans, blood work, chest x-rays, biopsies, et cetera. Typically, if it's an experimental drug in a study, the experimental drug is covered.
Now, there may be some hidden costs associated with clinical trials, like transportation costs if you live really far from the study center, and sometimes you can negotiate with the study folks to get reimbursement for that. Sometimes it's built in. Sometimes pharmaceutical companies will cough up a little extra money. But if transportation is an issue, as my mother said, "It never hurts to ask."
Slide #22
Confidentiality. The consent form should tell you who will have access to your records. Now, I can tell you that there are some laws coming down the pipeline in April that are going to severely impact this and actually make it maybe a little more difficult for us to conduct clinical trials in order to protect your privacy, which isn't necessarily a bad thing. It really just depends on how they're implemented. But you would basically want to know who's going to have access to your records, and typically it's the investigator and the investigator's associates, the pharmaceutical company, the FDA, and how is your privacy going to be protected? Where are my records going to be kept? Is my name on them? Is an ID number on them? Who has access to them? And that they'll be kept in a secure location. And this is sort of standard, routine stuff that's in a consent form.
Slide #23
You need to know -- and I always tell my patients that they're always free to withdraw from a clinical trial at any time without any penalty or prejudice to their medical care, and you are.
Slide #24
I really see informed consent as an ongoing process. It continues throughout the study as we learn new information, especially as it relates to risks, and at some point you actually -- if you do sign up for a clinical trial, you may be asked to sign a new consent form as we learn more about the risks of a particular treatment. You also have the right to ask for updates periodically. How are the other patients doing?
Slide #25
What I really see this whole process as is a process of informed decision-making. Treatment decisions can be very difficult, especially if you're under emotional stress, and if you've gotten a diagnosis of cancer, that's sort of a gimme. Everybody's under emotional stress at that point. But you want to make sure that you understand and accept everything that's involved, especially the potential risks. And if you don't understand, you need to ask for clarification.
I often tell my patients who are really having trouble making a decision about a clinical trial to sit down, hopefully with a trusted friend or colleague or family member, and make a list of the pros and the cons.
Slide #26
And despite what this Gary Larson cartoon seems to imply about curiosity killing the cat, there is no such thing as asking too many questions. Ask as many questions as you need to ask until you feel comfortable with the decision that you've made.
Slide #27
However, sometimes you need a translator, and sometimes the physician is not always the best person to answer those questions, and this, for those of you who can't read it in the back, says, "Doctor, can you please call my nurse to explain what you just said?"
Slide #28
And this really wasn't meant to be a plug for me or my colleagues, but I really do feel that clinical trials nurses, if you have the opportunity to work with them, can be very helpful to you in terms of teaching you about your disease and your treatment options and how to manage side effects, acting as facilitator to try and push things through the process, be it insurance, be it scheduling CAT scans, acting as a liaison to go back to the physician, as I've done, and say, "I'm sorry, but Mr. Jones just really doesn't understand what you just told him, so please go back in and do it again and do it better." To triage problems, side effects that patients are having. And what I see as the number-one role of the clinical trials nurse, and that is acting as a patient advocate, which probably incorporates elements of all of those things.
Slide #29
There are also patient advocacy organizations, and the Lymphoma Research Foundation is one of those, that provide information and support, act as liaisons with researchers, and also provide peer counseling.
Thank you, and I'd be happy to take any questions. [APPLAUSE] Any questions?
Q: [Inaudible]
SHEILA BRESLIN, RN, MS: It's Senate Bill 37, and I am not a big web-type person, but I found it, and I wish I could tell you exactly how I found it. I do have a copy that I'd be happy to share with you. It's written in a lot of legal jargon, and actually what you can do -- Who asked me that question? I wasn't wearing my glasses. Oh, thank you. Now I know who to look at. The American Cancer Society -- 15 states have similar laws on the books, and if you go to the American Cancer Society website, there is a phone number that you can call to get your state legislature. They can send you a copy of it, of the bill.
Q: [Inaudible]
SHEILA BRESLIN, RN, MS: No, the state does not cover the cost. The state mandates that your insurance company cover the cost of routine patient care costs associated with clinical trials. So if you have an HMO, then your HMO has to cover the usual costs of participating in a clinical trial.
Q: You used the term ... Can you explain that?
SHEILA BRESLIN, RN, MS: Yeah. I was going to explain that if I had time. I'm just conscious of your next session, but we have time. So a drug is typically approved for a certain indication -- like lung cancer, for example -- and maybe in some phase II studies it showed some effectiveness in ovarian cancer or lymphoma, but it's really not approved for that. So when it's used, then, in a clinical trial for lung cancer or lymphoma, the use is, quote, "off-label." So the labeling says its indication is for whatever I said it was approved for, and now it's being used -- Pardon? Lung cancer. And now it's being used for Lymphoma. That's an off label use. But it's an approved drug. It's just not approved for that indication.
Q: [Inaudible]
SHEILA BRESLIN, RN, MS: Well, you can, and people do, but your insurance might not pay for it. Mm-hm, back there?
Q: Is there a phase IV, a phase V?
SHEILA BRESLIN, RN, MS: There's a phase IV. There's not a phase V that I'm aware of. Phase IV are -- After FDA approval, sometimes they do phase IV studies, and they involve maybe testing a new way to give an approved drug, but they're -- After phase III, it's approved. So phase IV is maybe just refining it a little bit, looking at giving it in a different way. Do you have anything to add to that? No? Yes?
Q: In clinical trials, you mentioned you have a right to find out how ... Are they required to tell you ... problems?
SHEILA BRESLIN, RN, MS: Well, I would think only as ethics would dictate. I mean, we don't see the downside in telling our patients what's happening with patients who have preceded them in a clinical trial. I mean, that should be available to you by asking your physician. Now, your physician may say, "We don't know. It's too early to tell." And that's often the case. Yes?
Q: [Inaudible]
SHEILA BRESLIN, RN, MS: I'm sorry, can you speak up? I can't hear you.
Q: ... trials ... asking for that information --
SHEILA BRESLIN, RN, MS: Yeah.
Q: ... a phase III randomized trial?
SHEILA BRESLIN, RN, MS: Okay, phase III randomized is a little different, because no one has the answer until the study is almost done.
Q: [Inaudible]
SHEILA BRESLIN, RN, MS: Well, you're talking about a couple -- We're mixing up a couple of things. It's a little more complicated. If you're talking about a placebo-controlled study, remember, if there's an effective they out there, you have to be given that effective therapy. No one would give a patient a placebo if there was a known effective therapy. Placebo-controlled studies typically -- and this is the reason -- your physician wouldn't even know if you were getting a placebo, unless you had some severe, bad side effect that happened. Even if you went off the study because you just didn't want to do it anymore, they wouldn't tell you unless there was a reason. So placebo-controlled studies are little bit different, but with randomized clinical trials, the results are often not known for a while, until they've enrolled a certain -- It usually involves hundreds, if not thousands, of patients.
But when I see a patient and we have like a phase II clinical trial and we've treated 10 patients or 50 patients before, and patients want -- We'll give them whatever data we have. But often when a study is ongoing, it's too early to know what the results are to really give firm data.
Q: [Inaudible]
SHEILA BRESLIN, RN, MS: Could you just speak up a little?
Q: ... Is it true that they have separate arm for patients that are severely ill and ... phase II ... better, do they put them on a separate arm?
SHEILA BRESLIN, RN, MS: No. Usually, clinical trials exclude, in general, at least cancer clinical trials, severely ill patients.
Q: ... therapies ... have a separate arm ... you know ... placebo, they will be given the drug. You know?
SHEILA BRESLIN, RN, MS: You know, maybe we could talk about that later, because I'm not sure I understand your question. But maybe we could talk after. Okay? Yeah.
Q: With a trial, phase III, they know on the effective treatment what percentage of people are going to be successful.
SHEILA BRESLIN, RN, MS: Correct, mm-hm.
Q: Why do they need to do the placebo, since you're going to know with those people how many ...
SHEILA BRESLIN, RN, MS: Yeah, I do. So why would they need to -- If you have --
Q: Why do they need a placebo at all --
SHEILA BRESLIN, RN, MS: Right.
Q: -- because if you get a known quantity on the effective treatment -- you know, 60% of the people have a good response -- and you give them the new treatment with the old and it's 90%, we know the new treatment will be a 30% change. So why do you have to have ...
SHEILA BRESLIN, RN, MS: That's an excellent question, and maybe Dr. Sarosy wants to add to this, but it's to prevent what they call selection bias. So maybe the group that did really well on the treatment were an exceptionally healthy group of patients, and in order to know if there really is any benefit to a new treatment, it typically needs to be compared to something, either the standard treatment or -- so in the case of a vaccine, perhaps a vaccine plus placebo.
Q: But why would they -- we know that ... had the effective treatment. Why can't they find patients that are in the same category and then eliminate the other drug?
SHEILA BRESLIN, RN, MS: Because there's too much risk of investigator bias in terms of choosing patients for clinical trials. Maybe that investigator has chosen the absolute best group of patients, and so in order to -- It's statistics. In order to remove bias from study results, they decided many, many years ago that they needed to have studies where there was randomization and no bias in terms of selecting -- You're shaking your head. I'm not answering your question?
Q: Well, it just seems that we're working towards perfection when you get people dying of an illness, and you want to give a certain drug --
SHEILA BRESLIN, RN, MS: Again, a drug would never be withheld if it was known to be of benefit.
Q: Well, it is, because you can't have it unless the FDA approves it.
SHEILA BRESLIN, RN, MS: And the FDA won't approve it unless there's enough data showing that it's of benefit and that it's safe. There's also something called compassionate use, where you may not be eligible for a clinical trial, but you may not have any other options, and sometimes you can get an experimental drug on what's called a compassionate use basis from a pharmaceutical company.
Q: I was told that that is very uncommonly used, because the drug companies don't want to do that.
SHEILA BRESLIN, RN, MS: It's doable. It's just a lot of work. It's a lot of work for the physician.
Q: And then you have to be next to death.
SHEILA BRESLIN, RN, MS: Well, typically, you have to have very few options left. Any other questions? Yes?
Q: My husband is ... has participated in -- as a patient in a phase III trial ... but his physician isn't part of it, and he was really pushing him to consider to have the standard thing done, and there was some trials going on, and another study ... that would have been more appropriate. Is there any way to jump hoops ... your physician?
SHEILA BRESLIN, RN, MS: I don't know that I can answer that. I think that's a tough one. I think you can go to your physician with the protocol and say, "I want to do this one." And if your doctor doesn't want to do it, then find another doctor that will do it.
Q: Can I just ask you a question ... compassionate use ...
SHEILA BRESLIN, RN, MS: Compassionate use?
Q: ... I have a ... at Kaiser. I know that at Kaiser, if you ... and there's ... a phase II that does serve as ... may be a little better…[inaudible]
SHEILA BRESLIN, RN, MS: Well, again, it's an insurance thing. I'm not an insurance specialist, but at least Kaiser -- You know, your mom may have to go to UCLA, for example, for her visits, to get the experimental drug, but Kaiser should be paying for all the additional costs like Kaiser's -- should be paying for CAT scans and blood work, et cetera. Any other questions? Okay. Thank you all for coming. [APPLAUSE; END]
|
SUMMARY
