Clinical Trial MythBusters: Which Factors Can Exclude Me From a Trial?

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Topics include: Treatment and Understanding

What is the criteria for participating in a clinical trial? During this Clinical Trial MythBusters, Andrew Schorr, president and founder of Patient Power, consults with Dr. Heather Wakelee, Director of Stanford Cancer Clinical Trials Office at the Stanford University School of Medicine, to find out what factors influence the inclusion or exclusion of patients from trials. Dr. Wakelee also explains why they’re designed with standards of eligibility.

The Clinical Trial MythBusters series is a Patient Empowerment Network program produced by Patient Power. 

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Transcript

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Andrew Schorr:

Well, Dr. Wakelee, one of the questions that we got in is from Karen, and she’s, I have a feeling, whether it’s ovarian cancer, whatever, she’s worried that there are some trials where if she’s had a complication from her illness, she mentions a couple, pleural or pericardial effusion, can they be in certain trials, do they not qualify because of their situation? And maybe you could describe that. It’s really about whether people who are really sick can have access to trials.

Dr. Wakelee:    

Right, and again, it’s always the balancing act, like you’d mentioned before. The first thing we need to be thinking about is we do not want to risk harming someone. We don’t want to take away hope; we want to make sure they have opportunities to get studies, but we don’t want to put people at risk of harm with one of the treatments.

And so, a lot of the rules about the trials, as far as who can and cannot participate have to do with not wanting to harm folks when you’re dealing with medications you don’t know as much about.

So with pericardial and pleural effusions, those are usually not a reason that someone wouldn’t be able to go on a trial. But for some of the studies, we have to be able to measure whether or not the drug’s actually working. And so there are all sorts of conventions put in place as to how do you measure, what can you measure, what should be measured, what does it mean? And so when we discuss the results of a study and we show tumors shrinking by various percentages, we have to have a standard way of measuring. And so sometimes, someone has cancer, and you know it’s there, and you know it’s active, but there’s nothing to measure.

And so trials that are comparing whether one trial helps someone have a longer time before their disease comes back or live longer, being able to measure specifically doesn’t matter. But some studies, especially when they’re earlier, and we’re just trying to figure out, is this drug really doing anything at all, we have to be able to see, did it actually shrink the tumor? And if you can’t see the tumor, you can’t, so sometimes people are excluded for that.

And it’s really frustrating and sad when you’re the patient who wants to go on the drug and you can’t because you don’t fit those specific criteria. And again, those ones aren’t always safety that decides, but it’s that idea that if you only have people going on where you have no way of assessing whether the drug’s working or not, maybe you’re not really helping people, but you think you are, so it’s that balance.

And then, a lot of the other exclusions, sometimes they’re like, “Oh, you can’t have this type of heart rhythm, you can’t have a risk of this…” That’s really because we don’t want to harm people, and that, again, when you’re the patient and being told you can’t do this drug that you think is gonna be really promising, that’s very frustrating, but if you’re the patient who has that risk, and then you go on the drug and then it hurts you, that’s far worse. And so that’s how we’re kind of looking at it, but it’s always a tough balance.

We want to be able to offer these drugs, especially if they’re gonna help people, to as many as possible. But if we too early take too many risks and it ends up that there are a lot of side effects and problems because people who are really quite sick or had specific issues go on the study, that actually can stop the drug from ever moving forward. So it’s that balance too. It’s sort of stepping back, and how can we help the most people?

We want to help that one who’s in front of us in the office, but we also need to make sure that we don’t hurt them and we don’t risk preventing this medication from being available to others. So it’s constant balance.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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Page last updated on November 3, 2017