Transcription:

Melanie Cole (Host):  A key to improving cancer care is clinical trials, but how do they benefit cancer care? How do they work and how can you get involved in a clinical trial? My guest today is Dr. Robert Dreicer. He is director of clinical research and the deputy director of the UVA Cancer Center. Welcome to the show, Dr. Dreicer. Tell us a little bit about clinical trials. What are they and how are they run? 

Dr. Robert Dreicer (Guest):  I think the best way to define a clinical trial is to use the definition that the National Institutes of Health use. It’s basically research studies explore whether medical strategies, treatments, medical devices are safe and effective for patients and they may show whether medical approaches work best for certain illnesses or groups of people. That’s a nice sort of all-encompassing definition. 

Melanie:  Why have they been so important to advancing cancer care? What are clinical trials doing for us? 

Dr. Dreicer:  I think they have been absolutely critical to the really dramatic progress that’s been made over the last 10 to 15 years in managing a variety of the major cancers that we take care of. Because what it does is it gets us out of one doctor treating one patient with a certain treatment and seeing whether or not it works. That’s an anecdote. We don’t learn by anecdotes. We learn by carefully structuring trials to address the question about a drug or a device to say whether this is effective in patients and then ultimately, whether it works better than what we’ve done in the past. That’s actually been critical in making progress. 

Melanie:  If patients are considering participating in a trial, I think that this could make somebody nervous that maybe they’re not getting the standard of care or the care that they should be getting especially where cancer is concerned. How do you explain to them that a clinical trial might be the best option? 

Dr. Dreicer:  That’s a great question. Obviously, it depends very much on the circumstances that the patient is facing and there are different types of trials. Some that’s very early and those trials may be more appropriate for patients who have been heavily treated and have limited additional treatment options. As we begin to develop better therapies, trials that compare the standard treatment to a treatment that probably or maybe better is a different kind of study. For each patient, it’s really important to understand the kinds of trial that is being presented, what the standard of care is. Part of a physician’s responsibility is to make sure that patients understand these issues as they begin to contemplate participating in a trial. 

Melanie:  What protections are in place for those patients? What if they say, for example, “Well, this didn’t work for me and I wasted all this time when I could have been being treated”? 

Dr. Dreicer:  That’s clearly an understandable issue. The protection for patients in our system in the United States is extensive. There’s something called an Institutional Review Board and basically, what that is, it is a group of physicians, scientists, lay people, ethicists, whose sole goal – and this is a federal mandate – is to review what the clinical trial is, how it is being explained to patients to make sure that the risk/benefit ratio makes sense for patients. That happens before a trial is ever opened and before a patient ever is approached.

Melanie:  If somebody wants to look into clinical trials, how do they decide if a clinical trial is right for them? What things do you want them to look at and questions do you want them to ask? 

Dr. Dreicer:  I think the first question should be: What is the standard of care and why might my participation in this particular trial that I am being offered be rational compared to being treated by a standard treatment? Now, in some instances, there may not be a standard treatment, but that is still a legitimate question. What rationale is it for me to participate in this trial? What should I expect in terms of the time that I am committing to this, the side effects that I might expect from this therapy? And then contrast that with the side effects that I might get from a standard treatment. What’s the potential upside? Is it something that’s going to potentially cure me, might I live longer, or is this a trial just to see whether or not this drug is going to potentially make me feel a bit better, but not likely do more than that? Those are very important questions which, frankly, should be some questions that the patient doesn’t really need to ask. This is being presented to them as information.

Melanie:  Is there ever a time, Dr. Dreicer, when a placebo is what’s administered to a patient? Because, I think, that especially where medication is concerned and the effects of medication, that’s what patients seem to be afraid of, that they are going to end up in the placebo group and not get the help that they need. 

Dr. Dreicer:  That’s obviously a very important issue. I just would remind our audience that many trials are not comparative trials. Meaning, there are trials that are called phase one or phase two trials, in which patients all get treatment. That there are no randomizations, so there is no chance of not getting treated. In some phase three trials, these are comparative trials. Occasionally, there is no standard of care and a placebo, meaning no treatment, is actually what normally would be offered to patients. In fact, giving somebody treatment might be, in fact, the investigation arm. The critical nature of having the study rationale explained, taking some time to work through this, the one thing I would advise folks who are looking at trials is to remind themselves that they are not going into used car dealership. This isn’t about pressure tactics. This is about careful consideration, being thoughtful, and making sure that one has all the information you need and to be comfortable to make that decision. 

Melanie:  What a great answer! You mentioned the phase portion of the trial. Please explain that phase and what do you hope to achieve as you go through those phases? Is there some end goal with these clinical trials? 

Dr. Dreicer:  Briefly, we think about sort of three major phases of trials. Phase one, first thing human or finding the safe dose that can be further tested in a phase two trial. Phase two trial, a specific disease, say colon cancer, a specific drug or drugs. Does this drug or drugs have benefit to these patients with this disease? Phase three is comparing a new treatment or perhaps an older treatment to what is considered the standard, to understand whether or not one is the same or better than the other. 

Melanie:  Really, what would be your best advice? What are the benefits to patients coming to an NCI-designated cancer center like UVA Cancer Center? 

Dr. Dreicer:  Participation through the National Cancer Institute suggests a certain level of interdisciplinary management of patients, the kinds of expertise that is sort of clustered in major academic centers, the ability to sort of call upon our colleagues in basic science and translational science to bring the best, newest things into the clinic. Participation in a clinical trial also has a regimentation, meaning that the oversight from the institutional level, from the federal level, is extreme and, therefore, patients in that setting are getting basically the best therapies that we have across the world. 

Melanie:  Now, just one last question, if you would, Dr. Dreicer, when someone is considering a clinical trial, your kind of recap for us if you would please, what you want them to know about clinical trials and what you think the most important questions they should ask when they are exploring this. 

Dr. Dreicer:  Back in the day, patients who participated in clinical trials did it almost always for altruistic reasons, to help the next generation. Increasingly, with the developments of the therapies that we have, it is much more common for a patient to actually, not only help additional generations, but potentially achieve benefit for themselves. Patients need to be comfortable with the rationale of the trial. Why are we doing this? What are we trying to learn? What is in it for me? What are the risks for me? What is my time commitment going to be to this? Those are obviously pretty critical questions and I do not want to oversimplify this, but if you start there, and remember that there is no guarantee you have to make a decision. Sometimes, you need a little bit more time. I would rather have a patient be comfortable with a decision than to second-guess their judgment.  

Melanie:  Really great information, Dr. Dreicer. Thank you so much for being with us. You’re listening to UVA Health Systems Radio. For more information, you can go to uvahealth.com. That’s uvahealth.com. This is Melanie Cole. Thanks so much for listening.