On this last episode, we look back on 23 years of joyous, difficult and always informative conversation.
Medical breakthroughs rely on scientific studies. And scientific studies rely on medical volunteers.
But sometimes volunteers — healthy and otherwise — are hard to find.
Many people don’t realize that there are a plethora of studies in the Washington region short on human subjects, and that important research often stalls for lack of them.
Then there are those folks who just don’t like the idea of taking any risk with their health, or serving as a “guinea pig.”
But many myths swirl around this special sort of volunteerism. And the rewards — monetary and otherwise — are not always obvious.
Who is needed for these studies? Why do people sign up? And what do they experience?
Produced by Lauren Markoe
KOJO NNAMDIWelcome back. Whether it's a more effective treatment for cancer, a better artificial heart valve, or a vaccine to prevent a lethal disease, medical breakthroughs almost always rely on clinical trials, and clinical trials rely on real, live human beings. But many people shy away from volunteering, saying they don't want to be a guinea pig or a lab rat. While there can be risks, there are also good reasons to sign up for medical studies. Who are researchers looking to recruit, and what motivates people to enroll? Joining me to discuss all of this is Christine Grady, the head of bioethics at the National Institutes of Health. Christine Grady, thank you for joining us.
CHRISTINE GRADYThank you for the opportunity to be here.
NNAMDIKaren Craney is a subject in the universal flu vaccine study at the National Institutes of Health. Karen Craney, thank you for joining us.
KAREN CRANEYThank you very much.
NNAMDIAnd Channing Paller is a medical oncologist at Johns Hopkins. Channing Paller, good to see you again.
CHANNING PALLERThank you. It's a pleasure.
NNAMDIYou can join this conversation by calling 800-433-8850. Have you ever participated in a clinical study? What was your experience? Will you consider volunteering for a clinical study? Why or why not? 800-433-8850. You can send us a tweet at @KojoShow, or email to Kojo@WAMU.org. You can go to our website, KojoShow.org, ask a question or make a comment there. Christine Grady, who should volunteer for medical studies?
GRADYEveryone should think about it. The way, as you said very clearly, the way we make advances in understanding human health, human illness and ways to prevent and treat them is by doing research. And in order to really know what works in humans and what happens in humans, research requires the inclusion of human beings. So, everyone should think about how they might want to contribute to research.
NNAMDIIs a clinical trial designed to help participants, or to help people who would benefit from the trial's success in the future?
GRADYSo, the research in general is designed to answer questions that will help people in the future. That doesn't mean that people in the current trial will not benefit. Some of them do, depending on the trial. But research is really designed to answer important questions that will help us understand human health and human illness, and ways to treat it and prevent it. So, the beneficiaries are multiple.
NNAMDIDo most medical advances require human volunteers?
GRADYYes, most do.
NNAMDICan you give us some examples of medical breakthroughs that relied on volunteers? And, remember, we're only here for another half an hour. (laugh)
GRADYSo, just a couple come to mind right away. I mean, some of my clinical work was in HIV, and we have made major progress in understanding what HIV is, how to treat it and how to prevent it, by doing research. And research over the last couple of decades has made huge progress in all of those areas. Another example is childhood leukemia used to be a pretty universally fatal disease, and currently is one that 90 percent of children survive and are cured from. So, those are both products of research.
NNAMDIThe National Institutes of Health, which runs thousands of studies, recruits both sick and healthy people. Do they enter the system differently?
GRADYNot really. People can enter in a number of different ways. You can contact the contact person or the PI of any given study, and those are listed on the NIH Clinical Center website, but also on ClinicalTrials.gov. Or you can call the Patient Recruitment Office, and they will connect you with the people who are running a particular study. So, sometimes, people who have illnesses are referred by their own physician. But many studies take people who refer themselves.
NNAMDI800-433-8850. We're talking about volunteering for clinical trials. Have you or someone you know benefitted from a medical study? 800-433-8850. Karen, you are one of those healthy people who decided to enroll in a clinical trial. What study are you part of, and how did you get involved?
CRANEYI'm in the universal flu vaccine study, and I got involved by hearing about it at a job fair that I went to that was sponsored by the Jewish Social Services agency, in which they had a lot of different organizations and agencies talking about opportunities for folks to become involved.
NNAMDIWhat made you want to volunteer?
CRANEYI'm very--I've been blessed with good health, and I think that's really important, when you do have good health, to give back to the community. So, I saw this as an opportunity to be able to participate in something in which I could give back to the community.
NNAMDIYou're a retired Montgomery County teacher, not a scientist. But can you explain why the universal flu vaccine is universal? Why would it be an improvement over the current vaccine?
CRANEYWell, as we know, the current vaccine is based on the strains of flu that exist, and so it is only as good as the strain is -- what's happening with the strain. And so, as we know from previous vaccines, a lot of times, they are not effective. So, a universal one -- which, from my understanding, will be one that will be good for all strains, no matter what strain of flu is in existence at that time.
NNAMDIWere you told about potential side effects? Did that make you nervous?
CRANEYIt didn't make me nervous. The potential side effects, to me, were not that great in terms of receiving the vaccine. I just--they were told about things like watch for fever and swelling and soreness, and things like that, none of which I experienced.
NNAMDIWhat have you been asked to do in this trial?
CRANEYIn the trial, I have received the actual trial vaccine a couple of times. Each time that I go, I also give blood, because they're using the blood to obviously do some research on the effects of the vaccine. So, it's receiving the vaccine, giving blood, talking about how I'm feeling each time that I go, get the blood pressure taken, your height, your weight, all those kinds of things. So, it really has not been, I would say, overwhelming involvement on my part, but I think a very necessary one.
NNAMDIWell, I'm not a doctor, but how are you feeling? How have you felt since?
CRANEYFantastic. I've had absolutely no side effects from each administration of the vaccine. I had to take my temperature and do a daily diary, watch for swelling, you know, things of that nature, and I did not experience any of those things.
NNAMDIAre you being compensated for your participation?
CRANEYYes, there is compensation for the efforts.
NNAMDIWould you do it if you didn't get compensation?
CRANEYOh, absolutely. I mean, I actually didn't even know that there was compensation until I got involved in it. I saw the table, it sounded like an interesting thing to do. I signed up. I went for the initial screening, and that's when later I found out that there was actual compensation.
NNAMDIWould it be an invasion of your privacy for me to ask how much?
CRANEYI don't think so.
CRANEYI mean, the study is over an 18-month period, and I believe it's around $2,000 or so, depending upon how often you go and whether or not you do some extra things that are involved with the study.
NNAMDIChanning Paller, you're a medical oncologist. What does that mean?
PALLERIt means I work with patients with cancer, and I help them live as well as they can, as long as they can, whether that means I use surgery or radiation with my colleagues who do those things, or I give them my tools, which are immunotherapy, chemotherapy, or targeted therapy, to help them do better, longer.
NNAMDIYou say you always try to get your patients into clinical trials. Why?
PALLERI think it's important. I think they're our medical heroes. The drugs of today were in clinical trials yesterday. I think that it often gives patients an opportunity to get drugs that aren't on the market yet, that may help transform their life. I've had one patient, I remember that he had received all the lines of therapy we have approved for bladder cancer, and I got him, years ago, on a clinical trial for bladder cancer with immunotherapy, before it was approved. And he is alive and well today, four years later, which I'm excited to say. So, without giving any patient data away, I'm thrilled for stories like that that keep me going and excited to be in this field.
NNAMDINationally, a very tiny percentage of cancer patients are in studies. Why is that?
PALLERMostly, they don't know about it. Many patients are treated in the community, and most of the trials are done at research centers. We have a couple National Cancer Institute-designated research centers in our area, Georgetown and Hopkins at Sibley, and then in Maryland, University of Maryland, and Hopkins and the NIH. And those are really the hubs. There are some trials elsewhere, but mostly, they don't know about it.
NNAMDIHere is Caroline in Falls Church, Virginia. Caroline, you're on the air. Go ahead, please.
CAROLINEHi. I am currently in a clinical trial. It is a trial for a new drug for metastatic breast cancer, and it's been a great experience for me. So, I kind of wanted to call in and share that, because I think a lot of people are very anxious and uncertain about participating in a clinical trial, because they're -- I mean, largely because they're afraid they'll have a bad experience. And that's not been what's happened to me.
NNAMDIOkay, thank you very much for sharing your story with us. Channing Paller, a much higher percentage of children with cancer are in clinical trials. Why is that?
PALLERThey're mostly treated at research centers, and so they have more of a 50 percent participation rate, nationally, rather than the 5 percent of adults. And so they're able to get access to those trials.
NNAMDIGot to take a short break. When we come back, we will continue this conversation about volunteering for clinical trials, the non-scientists who help discover cures. 800-433-8850. What do you think researchers could do to get more people to participate in medical studies? Give us a call: 800-433-8850. I'm Kojo Nnamdi.
NNAMDIWelcome back. We're talking about volunteering for clinical trials with Dr. Channing Paller, who's a medical oncologist at Johns Hopkins. Karen Craney is a subject in the universal flu vaccine study at the National Institutes of Health, and Christine Grady is the head of Bioethics at the National Institutes of Health. Christine, you favor the participation of sick and healthy children in clinical trials, and pregnant women, too. Why?
GRADYBecause we need to know how to treat children and pregnant women. Pregnant women get sick. Children get sick. To know how drugs work in them, to know how interventions work in them, the best way to figure that out is by doing research that includes a small number of people who are children or pregnant women to learn about that.
NNAMDIHere now is Jane, who is on 95 in Maryland. Jane, you're on the air. Go ahead, please.
JANEI was -- I'm about 17 years out of my trial. I was put on -- or there was a trial between tamoxifen and raloxifene for preventing breast cancer. My mother died of it, my aunt died of it, my grandmother had cancer, too. So, at that point in time, raloxifene had been used for helping people with joint issues, I believe. But people also, therefore, had less breast cancer. So, they were thinking that it would be a good alternative to tamoxifen, which caused vaginal polyps, et cetera, and I was on the tamoxifen part. And, yes, I did get vaginal polyps. But, you know, I'm 17 years out, and I'm fine.
JANEI mean, they removed the polyps.
NNAMDIThank you very much for sharing that with us. Care to comment, Channing Paller?
PALLERI think that's a great story. In the olden days, people thought of clinical trials as a last resort, and this is an exceptional example of she had two good choices between two drugs, and she did really well.
NNAMDIYou mentioned one of your patients, let's talk about another, one that we'll call CB, who was reluctant to join a study. What happened?
PALLERI -- Mr. C to me from an outside group, and he was very scared of chemotherapy, and he really needed it, or he was going to die from his prostate cancer. He already had some neuropathy in his feet, and chemotherapy makes it worse. I convinced him to go on a clinical trial that was focused not only on helping him live longer with the chemotherapy, but also...
NNAMDIBecause he didn't think he would.
PALLERHe didn't think he would, and he didn't think he'd be able to tolerate the chemotherapy or he'd get benefit. And I had him go on a clinical trial. Of course, he was consented, it was his choice. But this trial was really to improve his quality of life, offering intravenous electrolytes, versus intravenous electrolytes plus IV vitamin C. And so he's done so well that he got through the eight cycles of chemotherapy, which is longer than the average person can tolerate chemotherapy, and he's been on for two years now. And it's quite an impressive story, and he's still doing well.
NNAMDIChristine, these are happy outcomes, but clinical trials don't always end happily for participants, do they?
GRADYThey don't always, although they usually do. There are risks associated with taking drugs, with taking interventions that are not known whether or not the risks are serious or not. What's interesting is if you look at the history of clinical research, the amount of risk that people experience is pretty limited, and there are also multiple sort of processes in the pipeline that are put in there to limit, or minimize the amount of risk that people are exposed to in clinical research.
NNAMDIHow would you assess the risk healthy people take when they volunteer for a clinical trial?
GRADYSo, what happens is a investigator will write a study, write a protocol, we call it, a study, and it will be reviewed by a number of people. It'll be reviewed for scientific value. It will be reviewed for protection of human subjects and studies by the institutional review board, and the investigator him or herself, plus all of those reviewers will have an eye to minimizing the amount of risk in any given study. So that by the time the study is offered to a person, a healthy person, the amount of risk is limited.
NNAMDIDoes the compensation for volunteering increase with the risk involved?
GRADYNot linearly. It is certainly -- compensation is given usually for time and inconvenience. The amount of time that you spend at a clinic being part of a research study, or the amount of travel expenses and other expenses you have, those are the kinds of things that are reimbursed. Oftentimes, there is money that is given for what's called inconvenience, which some people say is similar to risk, but it's not the same as risk. And so it's not exactly correlating with compensation.
NNAMDIChristine, African-Americans have been particularly underrepresented in clinical studies. Why, and why is that problematic?
GRADYSo, actually, there have been a number of groups that have been underrepresented in clinical trials, historically, and there's been attention in the last 20, 25 years to try to correct that. There are policies, for example, for all NIH studies. There are requirements for outreach to communities, for strategies for recruiting people who might have been underrepresented in previous studies, and then there are requirements for reporting the recruitment and enrollment that any investigator has. There are reasons. I mean, I think, as Dr. Pillar said before, there's -- some people don't know about clinical research. That's one reason. There are people who have heard bad stories or rumors about risks or things that sometimes are not even true. And, you know, so there's a misunderstanding about clinical trials. There's misinformation. There's people who don't have any information, and there's a sort of understanding, as you said earlier. Some people are worried -- I don't want to be a guinea pig, I don't want to be a lab rat. Interestingly, when we've done studies asking people who are in studies about how they feel, they generally describe being proud to be a participant in a study.
NNAMDIKaren, do you see yourself as a kind of ambassador for clinical trials?
CRANEYWell, I don't know about being an ambassador. That's certainly a highly coveted term. But I certainly feel like I am proud to be a part of that. I've actually had many friends say to me, as I think the first caller even said, about being anxious or being worried. I've had a couple of friends say to me, "Aren't you afraid you're going to get sick?" And I said, "Well, I'm at the NIH Clinical Center. Could there be a better place, if there was a problem?" But I said, "No, I am not afraid of being sick." I feel that this study wouldn't be happening if they felt that there were going to be really terrible side effects or things like that. So, I'm excited to be a part of hopefully what will be cutting edge in developing this universal vaccine, because think about the fantastic greater good that will come out of having a universal vaccine for the flu.
NNAMDIChristine, what's being done to address the underrepresentation?
GRADYSo, there are these policies that require recruitment and outreach. There actually has been quite a shift in recent years. So, if you look back, you know, 30 years ago, generally, clinical research was often white men. Now, we have more than 50 percent of clinical research participants, in aggregate, are women. And the percentage of people from different minority groups varies from study to study, but it's closer to, like, 15, 16 percent. So, we're really making some progress in terms of representation.
NNAMDIChanning Paller, you are running several studies yourself right now. As best you can, in layman's terms, what are some of the things you're trying to find out?
PALLERSo, each of them are asking a different question. There's a phase one trial, looking at the safety of a drug, the immunotherapy. There's a phase two trial, comparing a standard of care, plus a standard of care, plus a new drug that's not on the market yet. And there's a third example, which would be a phase three trial, which we're trying to get the drug to market. And it's really offering the standard of care versus the new drug as a competition. And those are the main types of trials that I offer.
NNAMDIYou say that insurance, or a lack of it, is often a barrier to participation in a study. How so?
PALLERUnfortunately, except for the NIH, which pays for the entire study, at most medical centers, you have to have insurance to get on a clinical trial, because the cost is just prohibitive. So, the trials only pay for what's a cost to the patient above what's paid for by the insurance company.
NNAMDIHow can interested people get involved in clinical trials?
PALLERSo, first place is their doctor. The second place is what was mentioned before, ClinicalTrials.gov. Going to that website by the government and looking for potential trials. I'd say a hot one for my patients is GumdropTrials.org. So, it's GU multidisciplinary D.C. regional oncology project. It's all the clinical trials in the tristate area, listed on a website. So, there's lots of different resources.
NNAMDICan you add to that, Christine?
GRADYI would echo them. I think ClinicalTrials.gov is a great resource to find any trial, not only locally, but nationally. And you can sort by different terms. There is also an NIH Clinical Center. Search the studies website. So, if you're interested in NIH studies in particular, that's a good place to look as well.
NNAMDIAre there any warning or encouraging signs that potential volunteers should look out for as they consider signing up for a clinical trial?
GRADYI don't know if I would say warning or encouraging signs. What I would encourage people to do is if they're interested in participating in a clinical trial, to first find out what it's about. What is the questions being asked by the investigators, and what does the study entail in terms of requirements for them -- numbers of visits, you know, types of vaccines that they're going to be taking, or drugs, how much blood, how much time. Those are the kinds of things that people care about. But, certainly, understanding what the purpose of the study seems critical to me, because some things you'll feel more compelled to participate in than others.
NNAMDIChanning Paller, you may have mentioned this already, but I don't know if it's the same patient that you have with kidney cancer who had a remarkable outcome after enrolling in a trial?
PALLERThat was a different patient. He also was very concerned about doing immunotherapy, and I had offered him standard of care immunotherapy, which was approved at the time. Or he had a choice of being in a clinical trial with two immunotherapies, to say is more better than less. And everyone's more is better, right? Well, toxicity is the question there, and he was worried about the toxicities. So, there's different toxicities than chemotherapy with immunotherapy, in terms of inflammation or itis of any part of your body. And so he was desperately afraid, didn't think it would work, thought he'd be one of the two-thirds it didn't work for, and he had an amazing response, and his cancer dissolved. And so that was another fun story, where it's exciting to be a part of these trials.
NNAMDIKaren, you have told skeptics, "I'm not a guinea pig. I'm a prototype." What do you mean by that?
CRANEYI think that rather than focus on the negative connotation of being a guinea pig, let's focus on the prototype. Let's focus on looking forward. Let's focus on what the greater good is that you're going to be doing by being a part of this study. And I think that's a better way to describe it than to describe it as, you know, oh, well, I'm getting stuck with needles, and I'm--you know, the traditional form of what we would think of as a guinea pig.
NNAMDIChristine Grady, both you and Channing Paller, have you been seeing trends over time in terms of people who are volunteering for clinical trials? Are we in an upward trend or a downward trend?
GRADYI think we're in an upward trend. I think more people are willing to participate than were some time ago. I think there's still a lot of people who don't know about research, though, and don't know about how easy it is, or how available it is, to be able to participate in a research study. And, of course, I work at the NIH, so I talk about NIH, but as was said before, there are lots of trials around the Washington region, and there are even ways you can participate in research online, if that's something you prefer to do, which is also a way to contribute.
NNAMDISame question to you, Channing Paller.
PALLERI think there's a variety of places of -- you can contribute by looking at your genetics and maybe knowing ahead of time what the potential is for you to participate, or your family, in clinical trials, should something come up. Those are some of the online options. So, I agree, there's a variety of options.
NNAMDIDr. Channing Paller is a medical oncologist at Johns Hopkins. Thank you so much for joining us.
NNAMDIKaren Craney is a subject in the universal flu vaccine study at the National Institutes of Health. Karen Craney, thank you for joining us.
CRANEYThank you very much.
NNAMDIAnd Christine Grady is the head of Bioethics at the National Institutes of Health. Thank you for joining us.
GRADYThank you for having me.
NNAMDIThis segment about medical trials was produced by Lauren Markoe, and our conversation about human trafficking was produced by Victoria Chamberlain. Coming up tomorrow on the Politics Hour, D.C. Council Chairman Phil Mendelson will be here to talk about the end of Councilmember Jack Evans' three-decade tenure on the Council, and all that the Council chairman has planned for this new legislative session. Plus, the state's attorney for Prince Georges County, Aisha Braveboy, is wrapping up her first full year in office. We'll take a look at her report card so far. That's all on the Politics Hour tomorrow, starting at noon. Until then, thank you for listening. I'm Kojo Nnamdi.
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