Published on October 15, 2018
When clinical trials are offered at several medical centers, or if you qualify for multiple trials, how can you be sure you’re choosing the right one? Which trial is the best option for you? Dr. Mike Thompson, from Aurora Research Institute, and patient advocate Jim Omel, discuss factors to consider when weighing your options, and share tips for patients trying to prioritize different trials to find one that’s best suited to your needs. Dr. Thompson also discusses the purpose and design of different clinical trial phases, and how more targeted therapies are influencing clinical research.
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Transcript | Finding the Right Match: Advice for Patients Who Qualify for Multiple Clinical Trials
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So, Jim, Mike Thompson mentioned earlier, gave lung cancer as an example and of course across immunotherapy, there are so many companies endeavoring to move this research along. So let's say you had lung cancer or one of these others where this is big, although it's going on in the hematology area too, so a patient says, oh, my God, there are all these trials, and I might qualify for one, two, three, four. How do I prioritize? What do I bet on? And maybe my own doctor is doing more than one.
So what do you say to patients if they become receptive to being in a trial and there's more than one trial that they qualify for?
That's a very good question, and it's a nice kind of problem to have, to have choices of trials. I think, Andrew, the best answer is the patient needs to look at what they are looking for. Are they looking for longevity? Are they looking for something that's going to expend their life? Are they looking for a trial that maybe will greatly improve their quality of life? Perhaps they're looking for a trial that gives them one pill per week versus two injections a week. So there are certainly effectiveness end points. There are different things that patients find of value.
But to answer your question it really comes down to each patient needs to ask themselves, what is it I'm looking for in a trial? Do I want something that makes my burden lighter? Do I want something that's going to extend my life? How much am I willing it accept as far as potential problems versus the standard of care that I know what the problems exist with if I don't go on a trial?
Right. So that's a question we got in, is they're trying to assess that. One was about how do I prioritize. The other is, by being in a trial, Mike, is it going to make me sicker? Like, to do I have to go through the valley of the shadow of death to get, hopefully, to a better place, and how do you discuss that with your doctor when not everything is known?
Yeah, maybe I'll kind of step back and say for phases of trials, Phase I, the intent—both ASCO and NCI say the intent of a Phase I trial is therapeutic. But the statistical design is to evaluate safety. A Phase II is to look at initial efficacy or how well it works, and Phase III is to compare versus standard of care the efficacy. So there's other types of designs, phase 0, Phase IV and other things, but it used to be, I think, you know, I—we would say don't go on a Phase I unless that's the last option because you've already gone through the safety initial efficacy if it's a Phase III trial.
It costs a lot of money to do Phase III trials so fewer are being done now, and we're kind of finding that in this era of precision medicine people are going on trials, and there's no one rule, but I look at it as if it's a study involving a lot of different groups of patients, a lot of—you know, it's not individualized to you, I don't know, but I think it will have less of a benefit probably than if it's something like a study designed for BRAF melanoma back when that was a study and you have BRAF. Well, it's targeted for you. It doesn't mean it will work, but even if it's an early phase, a Phase I or II trial, it's really aimed at your disease.
And we're finding this with venetoclax (Venclexta), with T1114, and there's other markers, FLT3 in AML, all these things, and sometimes we find that the drug doesn't work like we think it's going to work. The ALK and ROS story in lung cancer, it may benefit other people that we didn't recognize before, and that's part of—we're trying to find people besides T1114 that respond to venetoclax in myeloma because it looks like some people will.
But I think as we're getting more targeted therapy it doesn't mean there's no toxicity, but it at least has the suggestion that we're targeted more at your specific cancer. And some of these pills can have as much toxicity as IV chemo s, but our aim is to decrease toxicity and increase efficacy. And I think, like Jim said, you've got to look at different trials and hopefully with a physician who has time to sit down and run through several scenarios.
And some people will take the most aggressive therapy because that's what they're after, and some people will try something that's easier and closer to home. So everyone's values are a little bit different, and you have to try to individualize as a patients.
One thing about trial matching is besides clinicaltrials.gov, there's myeloma and other groups that are doing these matching, so you can put in characteristics of your cancer and you can try to filter out and get a closer approximation, including at clinicaltrials.gov you can click on the states in the surrounding area or how many miles you're willing to travel.