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Melanie Cole (Host): Clinical trials can be so important in finding new cures for diseases, yet many people are skeptical of participating in one. My guest today is Dr. Dina Halme. She’s the Director for Research Administration and Strategic Planning for UVA Cancer Center. Welcome to the show, Dr. Halme. What is a clinical trial?

Dr. Dina Halme (Guest): Good afternoon, Melanie. Thank you for having me on. A clinical trial is really just a research study that involves people. The study will explore whether a medical approach or treatment or device is safe and effective for humans. So, really, a great way to think about is that all of the current treatments for breast cancer such as Herceptin, aromatase inhibitors, tamoxifen, radiation-- all of the things that we do right now to treat breast cancer patients were studied in several clinical trials. I think that you could extend that to say that clinical trials are an essential step in discovering new ways to prevent, detect, diagnose, and treat cancer. Clinical trials are particularly important because they help researchers learn both what does and what does not work in people. Our focus is generally on treatment but it’s also important to note that clinical trials can tell us more than whether a treatment works. They can help answer questions like, does the treatment work better than other treatments; does it have any side effects; if it does have side effects, are those side effects acceptable when weighed against the benefits of the treatment? So, really, clinical trials are essential to our being able to advance medicine.

Melanie: Do they typically happen, because people have this question, before FDA approval or after?

Dr. Halme: Ah, so there are two kinds and the majority of them occur before FDA approval. In order to get FDA approval, you have to be able to demonstrate to the FDA that the medication or treatment that you would like to have their approval for is both safe and effective in people and the only way to do that is through a clinical trial. After FDA approval, there’s something called “post approval monitoring”. And there may be trials that would involve, rather than a small number of people, hundreds of thousands of people over a long period of time to see if there are any unexpected side effects or long-term consequences of the drug.

Melanie: Why do you think that people are skeptical of clinical trials?

Dr. Halme: I think that people worry that either they’re going to be guinea pigs or that they won’t be getting the best possible treatment and I would really like to reassure people that neither of those things are true. For instance, in a clinical study with cancer patients, a cancer patient cannot be given a placebo or a therapy that’s known to be ineffective. So, a placebo can’t be used if it would mean putting people at risk by denying them effective therapy. So, patient’s participating in cancer treatment clinical trials must be given the standard treatment. Now, sometimes the study might be comparing standard treatment plus a new drug and then the comparison would be standard treatment plus placebo. But, you see, in either case, the patient is always getting what we know to be the best available therapy to date. So, I think that that’s one fear. And, another fear really is related to whether people are approached about clinical trials only if they are out of other options. And, I’d like to hopefully debunk that myth as well. So, basically, clinical trials in some cases are reserved for cancer patients who’ve exhausted all of their other treatment options but most studies are designed to compare the current standard treatment with the one being developed. These would be open to patients with earlier stages of disease or they might be other kinds of trials like trials to study methods for preventing cancer and people with high risk or detecting and diagnosing cancer or even preventing recurrence in patients with cancer is in remission or has hopefully been cured. And then, there’s a whole area of clinical trials which I think is increasingly appealing to patients to participate in, which is improving the quality of life of cancer patients and survivors, particularly because many of the treatment regimens for cancer are so difficult for patients in the process of being treated.

Melanie: I’m glad that you pointed out that they’re not just for people who have no other options. And, let’s bust up a few more myths. Do health insurance companies cover the cost of a clinical trial?

Dr. Halme: Great question. So, it depends. Your health insurance may pay for some or all of the treatment. Most of the time, the way it works is the study or the clinical trial will pay for the study therapy and insurance companies will pay for the routine care. So, it is unusual that a patient would participate in a study where it would cost them anything to participate. Usually, the costs are covered either by insurance or by the study itself.

Melanie: What’s informed consent? And if, once you’ve defined it for us, once you’ve signed that form, do you, are you legally bound to participate in this trial?

Dr. Halme: Ah, another great question. So, informed consent means that before a patient agrees to participate in a study, they really need to know what they are agreeing to do. So, they’ll be informed of the potential benefits but equally importantly of the potential risks of participating in the study. And, it’ll be explained to them why researchers and physicians think that this is a good idea to test in the clinical trial. So, they need to have all of their questions answered before they can give informed consent. And so patients should really feel free to ask as many questions as they need in order to get all of the information they feel they need in order to make an informed choice or give informed consent. However, once a patient gives informed consent, they are in no way bound to maintain being in the study. So, a patient can quit a clinical study for any reason at any time. So, I want to say that again. Patients can quit a study for any reason at any time; just because they don’t want to anymore is totally sufficient and this will not affect the quality of care that they receive if they decide to withdraw from a study or if they decide not to participate in first place.

Melanie: I think another fear or another myth that we can break up here: can patients expect to be, to have reviews on what’s going on with them. They feel that they can’t always expect the medical personnel to keep them informed and that they just have to go through blind.

Dr. Halme: So, I think that is also a myth. I think that the same way any patient who’s receiving medical care of any kind should feel empowered to ask their care providers what’s going on. The same is true for patients participating in clinical trials.

Melanie: I’m glad you said that because people feel like if they’re given results and information during a clinical trial that it ruins the end result of the trial but that’s not true, yes?

Dr. Halme: That is not true.

Melanie: And, you also mentioned the placebo situation. What do you tell patients when they ask you, “Well, is there you know a randomized placebo? Is this. . . How does it work?”

Dr. Halme: Well, it really depends on the trial and the thing that we make sure to do is to give accurate information to the patients about the particular trial that they’re being asked to consider participating in. So, placebos would really only be given if no standard treatment exists in a study to test drugs that might prevent cancer or, as I said before, in combination with a current therapy. So, placebos are never given when there is a therapy that could be offered.

Melanie: And, what do you tell somebody who’s on the fence about clinical trials and they say, “Well, I’m just not sure if that’s for me.” What do you tell them about a reason if you think, as their doctor, that they should be involved? What do you tell them if they’re on the fence?

Dr. Halme: Well, I tell them to keep asking questions, really. What are the risks? What are the potential benefits? What extra work will be required of them? Will it cost them anything? You know, ask as many questions as they have. Then, really think about what is the potential benefit for themselves? How risk averse are they? How afraid are they of untested risks, and then, really to encourage them to think about how they can expand knowledge or treatment. So, if a patient is unsure about whether or not to participate in a trial, I would strongly encourage them to ask lots of questions. But, ultimately, one of the things that help a lot of our patients decide to participate is that even if the study doesn’t help them, it’s expanding our knowledge or developing new treatments that may help others in the future.

Melanie: Do they have to stop their standard therapy to participate in a clinical trial? If they are already in treatment, maybe chemotherapy or radiation, whatever it is, do they have to stop that standard therapy to participate?

Dr. Halme: Usually not. Usually whatever the standard treatment is would be incorporated into the study because the study is designed to add on to standard treatment rather than to replace it.

Melanie: And, what if this treatment, this clinical trial works for somebody and then the trial ends, will they not have access to that experimental medication or treatment when the trial ends, even if it is working for them?

Dr. Halme: That’s a great question. So, it depends on whether or not the company is willing to continue to provide the drug. And, in most case, they are because there is something called “compassionate use” or “expanded access program”. And so, the drug will continue to be available, not through the trial because the trial may have ended, but through the same physician and from the same company that makes the drug.

Melanie: And, in just the last few minutes, doctor, please just wrap it up for us about clinical trials; what you want people to know; and why they should look to UVA Health System Cancer Center for their care.

Dr. Halme: Well, I think the most important thing is for people to remember that many of the wonderful treatments that we have available today are all dependent on the fact that other patients in the past were willing to participate in clinical trials. I would encourage everyone to take the opportunity to participate in a trial if one is offered to them. I think UVA Cancer Center is a great place for that because we offer trials across the entire spectrum: treatment, diagnosis, imaging, detection, prevention. And, in addition, we’re doing a long-term study that we’re approaching all of our cancer patients about called “Partners in Discovery for Total Cancer Care”. And it’s part of a consortium of fifteen centers around the country where we’re collecting data and leftover biological specimens. So, that would be if someone has surgery and we don’t need all of the tissue for clinical purposes. We’re collecting all of these data and specimens and sharing them to be able to have studies over time and resources available for patients to be included in studies in the future. So, UVA really has the whole gamut and I think that if patients were to come here, they’d be given the opportunity of whatever is the cutting edge standard treatment or the potential to participate in a trial where they may have access to something that they can’t get in the community.

Melanie: That’s absolutely amazing and so glad to have spoken with you today. You’re listening to UVA Health Systems Radio. For more information, you can go to www.uvahealth.com. That’s www.uvahealth.com. This is Melanie Cole. Thanks so much for listening.