Over the past 40 years, breast cancer treatment has greatly improved due to lessons learned through clinical trials. But for many people, the idea of clinical trials may seem daunting or risky. Today, we’ll learn the truth about clinical trials, and how to find options that best meet your needs.
Dr. Kathy D. Miller received her MD in 1991 from the Johns Hopkins School of Medicine in Baltimore, MD. Dr. Miller completed internal medicine training at Hopkins, then returned to her native Midwest for fellowship training at Indiana University, serving as Chief Fellow in 1997. She returned to Indiana University in 1999, attaining the rank of Professor and Ballvé-Lantero Scholar in 2014.
Dr. Miller’s career has combined both laboratory and clinical research in breast cancer. She became chair of the ECOG-ACRIN Breast Core Committee in January 2014. In this role she works with academic scientists and community oncologists to develop trials that combine clinical and biologic endpoints yet remain feasible in non-academic settings. Dr. Miller honed her ability to coordinate multi-center trials as principal investigator for three previous ECOG trials. In addition she serves as principal investigator of the National Clinical Trials Network at Indiana University.
Adam: [00:01] Over the past forty years breast cancer treatment has greatly improved due to lessons learned through clinical trials, but for many people, the idea of clinical trials may seem daunting or risky. Today we’ll learn the truth about clinical trials and how to find options that best meet your needs. To help us separate the myths from the facts let me introduce Dr. Kathy Miller. Dr. Miller is the Associate Director for clinical research at the IU Simon Cancer Center. Dr. Miller, welcome to the show.
Dr. Miller: [00:31] Thank you, Adam. It’s a pleasure to be with you.
Adam: [00:34] So talk me through this. I am not very familiar with clinical trials, so can you help me define what a clinical trial is and sort of what it means for patients?
Dr. Miller: [00:44] So clinical trials is really a very general term and it’s how we test new drugs, new interventions, new ways of caring for patients in the clinic. It’s really important that we know that the treatments we’re offering patients, the interventions and the advice we’re offering patients really is helpful and this is how we learn what works and what doesn’t work.
Adam: [01:12] Right, right that makes perfect sense and so what are some of the benefits of participating in a clinical trial?
Dr. Miller: [01:19] So let’s talk first about what sorts of clinical trials there might be because it’s such a broad term and the benefits are a bit different depending on the situation. So when we think about trials that are testing new drugs they go through many different stages or phases. A phase one trial is often testing a very new drug and it may be the first time that that drug has been given to people, the first time that drug has been used in combination. A phase two trial is a little bit farther along. We know how to use those drugs safely. We know what their side effects are.
[01:56] The question for phase two trials is how well does that drug work? How well does it work in a specific disease or a specific group of patients? The final step before a drug becomes approved is a phase three trial. A phase three trial compares that new treatment to the current best available treatment for that situation so they’re often randomized, they’re much larger. They may enroll several thousand patients. They’re really how we know, is this better than what we currently offer patients?
Adam: [02:31] And am I safe to assume that the different stages or different phases have different numbers of people in each trial and it just progressively gets larger, the latter the stages.
Dr. Miller: [02:42] Absolutely, so in phase one trials where we’re testing a very new drug the main scientific goal of those trials is to understand how the drug is metabolized and distributed in the body. To learn about its side effects and how to give the drug safely and we start to get some hints about how effective it might be. So as you might imagine phase one trials are pretty small and they tend to go pretty slowly because we want our patients who joined us in clinical trials to be as safe as possible so phase one trials may enroll one patient at a time. They may enroll three patients and then follow them for several weeks to make certain we understand the side effects before they enroll another small group of patients and gradually increase the dose or the schedule.
Adam: [03:30] Okay and I assume that the benefit of a clinical trial is that that particular drug may work better than what’s currently on the market and accessible to sort of the average patient. Is that correct?
Dr. Miller: [03:44] Absolutely, so at its heart, Adam, we do clinical trials because we know our best available treatments don’t work for everybody. We still have people who have a recurrence of their cancer. Who still die from their cancer, so while we’ve made tremendous advances in the last forty years, we’re not done. So all of the current treatments that are available, approved, and considered the best available standard care, at some point were the new treatment that went through these phases, so for many of our patients, being part of a clinical trial is a way to get access to a new treatment that would not otherwise be available to them because it’s not yet approved.
Adam: [04:29] Okay, I love that and so for someone that is considering a clinical trial, what questions should they consider asking the research team before joining the trial?
Dr. Miller: [04:41] So there are a lot of things I want to focus on. They certainly want to understand what phase of the trial is this, hat do we know about this drug and particularly about its side effects? They want to know some practical things. How often will they need to be in the clinic? Are there any additional tests or procedures that they would need to have because of part of the trial. They’ll want to know about any financial implications. Clinical trials will provide new drugs without patients having to pay for them.
[05:12] If there are extra tests or procedures those, should be paid for, but procedures or tests that are considered standard of care will still be billed to the patient or to their insurance carrier so they’ll want to understand those practical details. They’ll also need to think about how comfortable are they with the idea of being part of a clinical trial at this phase.
Adam: [05:36] Right, you know on the one hand there could be some degree of risk because it’s testing something new. On the other hand, there could be significant reward because it’s testing something new. Is that kind of your take on that as well?
Dr. Miller: [05:47] It is all those things and particularly the earlier a drug is in it’s testing, the harder it can be to evaluate that benefit and risk because we simply don’t have as much information. I think many of my patients mentioned another benefit that they see. Many of them recognize that they were the beneficiaries of what we learned from the patients before them who were part of clinical trials and they often look at being part of a clinical trial as their way of contributing and while still trying to get the best treatment for themselves, also helping us learn and that’s a crucial thing to recognize.
[06:29] If nobody was ever part of these clinical trials then we would have no new medicines. We would never do better than we are able to offer to patients now, so our patients who are not part of trials have benefited from the patients who were part of trials that defined that standard of care. I think it’s important to recognize that even if a drug is ultimately not successful, we’ve still learned from that experience.
[06:59] One of my own patients who needed to stop treatment in a trial because she was having side effects that were really too troublesome for her to continue, apologized to me for failing the clinical trial and I had to choke back tears explaining to her that she failed nothing. We learned from her experience and as exciting as it is to see a new drug work for the first time, we also need to understand when drugs don’t work or when they cause side effects because all of that information is valuable.
Adam: [07:32] That’s right, that’s right. Wow, I love that story. Thank you for sharing that and so who can join a clinical trial and how do they enroll in it?
Dr. Miller: [07:42] So each clinical trial will have a list of criteria that patients need to meet to be part of those trials. Those criteria serve several purposes. Importantly, we want to make sure that our patients on clinical trials are treated in the safest possible way. So for example, if we expect a new drug might cause damage to the kidneys, the trial would exclude people who already have some kidney damage because that would be more risky for those patients and wouldn’t make sense for them.
[08:15] Some of the criteria are because of the question the trial is asking, so patients will need to talk to their physicians about whether they’re eligible for those trials. They might also need to ask their physician to consider referring them to another physician to talk about clinical trials because not all physicians participate in clinical trials.
[08:35] I think patients should ask is there a clinical trial that I should consider every time they need to make a treatment decision. Often people focus on clinical trials or think about clinical trials as that’s what you do when the current standard isn’t working anymore or when you’re out of options. Well, phase three trials are comparing new treatments to the best current treatment, so those are often available to patients receiving their very first therapy. So I think patients whenever they’re making a treatment decision should ask is there a clinical trial that would fit my situation that I should consider?
Adam: [09:18] I love that and had not really considered that so I appreciate you sharing that particular perspective on it. And so my last question, and maybe this is a little bit of a loaded question, but what are some of the biggest myths versus the actual important facts that we need to hold on to for us to remember about clinical trials?
Dr. Miller: [09:39] So I think one of the biggest myths is that patients won’t get treated. They will only get a placebo and that is certainly not the case in cancer clinical trials. Now the trial may use a placebo, but that would be in a situation where we are comparing the current best standard of therapy to the current best standard of therapy plus a new drug. Knowing who’s getting what drug may bias the way we evaluate their disease and the way we look at the side effects they report, so in that situation, the trial might give some patients the best standard care with a placebo, but nobody would be getting a placebo by itself.
[10:21] I think the other myth is that once you have started treatment on a clinical trial you are stuck. You’ve made this commitment; you can’t get out. You can’t stop. That’s also not true. We want patients to have the best possible and the safest possible care and sometimes that means stopping treatment on a clinical trial because it’s not doing what this patient needs so our patients always have the ability to stop participating in a clinical trial.
Adam: [10:51] Wow, okay that’s great and those are both myths that I may or may not have subscribed to at some point. So I’m glad that you helped us to clarify that because really understanding what all of the options are really helps people make better decisions.
Dr. Miller: [11:06] Even when a clinical trial is available I sometimes talk to patients and tell them I have a clinical trial that you would be eligible to be part of, but I don’t think it’s actually the best option for you right now. Here’s why I don’t think that’s the best option, but if we don’t talk about clinical trials as an option then the times when it is a better option than the current standard of care, we’ll never identify.
Adam: [11:34] That’s right, that’s right I love that. Well, Dr. Miller, do you have any final thoughts you want to share with us before we part ways for the show today?
Dr. Miller: [11:42] So perhaps a sobering thought that explains why I’m so passionate about the clinical trials and the clinical research that we do. There are many more ideas about interventions and new treatments than we’re able to test because only about 3% of adults with cancer are treated in clinical trials. In comparison, about 80% of children with cancer are treated on clinical trials, so imagine what we might have learned and how much farther we might have come if more of our patients were treated on clinical trials then we were able to test more ideas more quickly.
Adam: [12:26] Right, I love that. I love that and it would produce, I mean better results, right? Ultimately the more testing we can do the better medicine that we can create and hopefully we can get closer to taming this problem, right?
Dr. Miller: [12:41] Absolutely, that’s why we do this and this is how we will continue to make progress.
Adam: [12:46] That’s right, that’s right. Well, Dr. Miller, thank you so much for being on the show. This was really informative and I really appreciate your time and I’d love to have you back again sometime.
Dr. Miller: [12:54] I’d be happy to come back anytime, Adam. Thank you for the opportunity.
October is National Breast Cancer Awareness Month. Support the fight by donating to Susan G Komen.
Intro and outro music is City Sunshine by Kevin MacLeod. The Real Pink podcast is hosted by Adam Walker, produced by Shannon Evanchec and owned by Susan G. Komen.