Clinical Trials: What's in it for me?
Arline Kallick: Hello everyone and welcome to the Network of Strength (formerly Y-ME) ShareRing Network national teleconference.
Our call with begin with tonight’s speaker, Dr. Hyman Muss. Dr. Muss is currently Professor of Medicine at the University of Vermont College of Medicine. His major research interest is breast cancer with a major focus on the treatment of breast cancer in older women. He also has an interest in adjuvant therapy and the treatment of metastasis. With his colleagues at the Vermont Cancer Center, he is trying to define molecular factors that predict which patients with early stage breast cancer will derive the greatest benefit from chemotherapy or hormone therapy.
In addition, Dr. Muss served for 10 years as the Director of Hematology/Oncology for the Fletcher Allen Health Care and he is currently co-chair of the Cancer in the Elderly Working Group for the Cancer and Leukemia Group B, a National Cancer Institute sponsored cooperative group, and in this endeavor he is trying to increase awareness and clinical trial opportunities for older patients with all types of cancer including breast cancer.
Tonight’s topic is “Clinical Trials: What’s In It For Me?” This will be followed by a questionand answer session and end with small group discussions.
A reminder, as you all know, we have a new number and you all got through so it was successful. I’m glad about that.
We realize it’s difficult to answer everyone’ questions in a one hour teleconference. So if your question does not get presented during the question and answer or the group discussion, please contact the Network of Strength YourShoes support center at 800-221-2141. YourShoes is answered by certified peer counselors who are breast cancer survivors and it is available 24/7 or visit our website at www.networkofstrength.org.
When presenting a question to Dr. Muss, please be courteous to other callers by keeping your question brief and realizing that this cannot be a private consultation.
A transcript of each call will be available at our website around a week from now. And beginning this month, we’re happy to offer a pod cast and that will be available at our website, which means you will be able to listen to a program at your leisure or read the transcript.
So we’re ready to begin tonight’s teleconference and we welcome Dr. Muss. You may begin.
DR. HYMAN MUSS: Well, it’s a privilege for me to talk to the group and thank you for the wonderful introduction. I’d like to thank Arline Kallick and all the Network of Strength people for allowing me to do this presentation on clinical trials. As we will talk about a little later, I’ve had the opportunity of working with Network of Strength on a trial of our own and it’s been really very gratifying to work with the group.
“Clinical Trials: What’s in it for me?” Well, I provided this really in the four parts. First, we’re going to talk about what are clinical trials? And then how do we support clinical trials, especially in the United States? How do you find a clinical trial if you’re interested in participating, and then last one why do it, why should I be in a clinical trial?
So to being with, what are clinical trials? What I often find is people think clinical trials are testing of like new drugs that haven’t been used before in a group of patients and it’s frequently the comment or perception that someone’s a guinea pig and that no one knows whether this drug is safe or not and going to see if it works, let’s say, in breast cancer. I would say that that’s probably a very, very small portion of all the things that involve clinical trials. For instance, most of the larger trials and trials that have led to major advances have been what we call randomized clinical trials where patients are asked to participate in a trial where essentially a computer does a coin flip and randomizes patients to one treatment or another, a so called Phase iii trial. Those trials frequently compare standard treatment, or if there isn’t a standard treatment for disease, a placebo with either a new or promising treatment. And in those trials usually the newer treatments have been tested on large numbers of patients but it’s uncertain whether the treatments really are beneficial. And if we look at breast cancer, for instance, a lot of the new chemotherapy regimens, these have all been compared in large randomized trials versus older treatments have been shown to be more beneficial. Likewise the use of newer drugs, for instance like aromatase inhibitors as hormonal therapy of breast cancer. These were developed in clinical trials, at least their efficacy in the population, comparing it with drugs like tamoxifen, other drugs in thousands of patients.
So really in these trials people aren’t getting a new drug. It’s not like someone is walking in the room with a big syringe with red liquid in it and everybody is scared to death that they’re going to explode when they’re treated. But they’re actually getting treatments that have been developed and compared with one another.
Frequently when we get a new drug we do test it in breast cancer patients, but these drugs are frequently well defined in Phase I trials. And in those clinical trials we treat patients who all have different types of cancers who don’t have really good options for treatment and those trials we really look at safety in dose finding and, of course, we’re always looking in these trials for treatment efficacy, for improvement, for tumor shrinkage. So when most of the drugs come into, for instance, a group of breast cancer patients, virtually all of them have had extensive testing in human beings. We know a lot about the side effects. Obviously we all see things can happen late and occasionally we miss side effects in early testing, but the drugs are really as safe as possible for the population.
Now when we think of clinical trials I think a lot of people think it is just drug testing, but clinical trials can look at other things. For instance, we’re involved in a very large trial through the Cancer and Leukemia Group B so every time you pay taxes, a small portion goes to the National Cancer Institute, really one of the great governmental bodies we have supporting research, and then that money comes into a group, to a group like ours and we get together groups of hospitals. So we have University of Chicago and Vermont and Sloan-Kettering, Seattle and all types of wonderful hospitals and medical centers all over the country, and we develop clinical trials. And we’re just about completing a trial looking at chemotherapy in women over 65 with breast cancer.
As part of this trial, we’re really looking, not only at just whether the drugs work, but we’re looking at how the drugs affect quality of life. For instance, one drug may be a little bit better than another but if people’s lives are really hampered taking that drug - they can’t function well, they can’t go out and do and work, they can‘t do activities of daily living - a little bit of improvement in tumor shrinkage or survival by a few months might not be worth all the side effects. As an example of this trial, we have, as part of it, for women who are undecided the opportunity for those patients to talk with a Y-ME volunteer and this is actually built in and supported by the trial. It’s a discussion with a patient who’s ambivalent about going about the trial as to what would be the risk and benefits. As part of this trial, we’re also looking at quality of life outcomes. We’re seeing if people on one of the two treatments, are they functioning better, are they having less side effects, et cetera. So when we look at a clinical trial, we think of drugs but it can look at other things.