Published on August 29, 2017
Before considering a trial, many patients wonder: "Is a clinical trial right for me? How would it affect my family? Do the risks I might be taking outweigh the benefits?" These are all questions our panel of experts discuss and debunk during this program. Watch now to learn more.
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Transcript | Are Clinical Trials Only for Patients at a Certain Stage of Disease?
Sent in a question, she said, “Are clinical trials only for patients starting on a new treatment? How about those already in an FDA-approved therapy plan looking for an improvement in their treatment?”
So that's a wonderful question, and what I would say is that we have clinical trials available for patients at every stage of their treatment. So a proportion of clinical trials will be evaluating patients that are just starting their journey where other clinical trials are looking at or aimed at patients that may have already progressed on their first line of therapy, their second line of therapy, their third line of therapy.
And I think speaking to Michael's point is that the idea is to turn this into a chronic disease, whatever cancer you have. You know, so if you weren't eligible or you progressed on your first-line therapy, that's no reason to lose hope, because there could potentially be a clinical trial option for you at that point in your treatment course.
So, Sheila, maybe you know the answer to this one. Susan wrote in with a question, “If a patient is not doing well at a certain point in a clinical trial, can they be removed, or can they stop the trial at that point but then later be brought back to it?” So in other words, because I some think people have the fear, oh, my God, having this side effect, I don't want to tell them because I don't want to be dropped from the trial. So how does that work?
Yes. Most clinical trials have written into them dose modifications if there are any side effects from the medications, both on the standard arm and the investigational arm. So we definitely have patients who will stop therapy or reduce therapy until the side effect resolves itself and then restart. And every study is written with very specific—well, they try and help to suggest to the physicians. It's always up to the physician how to manage the side effects, but they have suggestions on what the physician might do to manage it and then criteria for when they can reinitiate the investigational therapy. So, again, it's all about the safety, but we definitely—the study wants to keep people on study, so they can benefit from the therapy.