How do clinical trials work, and who can participate?
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What personal experience highlights the challenges of enrolling in clinical trials?
Hey, it's Flora, and you are listening to Science Friday. We're kicking this conversation off with a story.
Science is personal, and when you have a chronic illness like I do, the drugs that you get make a huge difference.
This is Chris. He's from Florida, and he called us because he tried to get into a clinical trial, and his experience raised some questions. Chris has autoimmune arthritis. Over the years, he's taken 10 different drugs, and they all worked, but each one for less time than the one before.
And when the drugs work, you really do feel like those commercials. You're dancing around and leaping off of the playground into the swimming pool, and then when they stop working, you get really sad.
So Chris tried to enroll in a clinical trial for a new drug for his condition.
Because new drugs are being developed all the time. And I thought, oh, this will be perfect for me.
What are the eligibility criteria for clinical trial participants?
But Chris was rejected from participating. And he was rejected because he was on his 10th drug, which of course makes him exactly the kind of person who might benefit most from a new drug.
And I really wondered what you're supposed to do if you're one of the problem children who doesn't meet the eligibility criteria, because on one level, who needs a clinical trial more than the guy who's quote unquote failing his 10th drug or having the 10th drug fail him, depending on how you want to phrase it.
So that is what we're looking into today, clinical trials and how they work. Are there incentives for drug developers to leave out, quote, problem children? Or is it more complicated than that? Here with us is Dr. Holly Fernandez-Lynch, a lawyer and a bioethicist who studies the ethics of clinical trials and the FDA's pharmaceutical policies at the University of Pennsylvania.
How do inclusion and exclusion criteria affect clinical trial outcomes?
Holly, welcome to Science Friday. Thanks so much for having me. Let's get to Chris's experience. I mean, is this the norm that drug developers exclude people from trials who have, quote, failed other drugs?
So, yes, it's very typical that when you're doing a clinical trial, you need to specify what the inclusion criteria and the exclusion criteria are. That's part of doing good science, because what you're trying to figure out is whether the drug works and you want to be able to attribute the outcomes that you're seeing to that intervention rather than to extraneous factors that might influence the results. So inclusion criteria are, of course, going to be things like you have the disorder of interest. And exclusion criteria could be a wide variety of things, including your age, maybe your BMI, your ability to speak English and consent on your own behalf. And it would also typically include things like comorbidities, other diseases that you have that could influence the study outcomes.
What role does the FDA play in the clinical trial process?
And related to that might be other drugs that you have previously tried. So if you're like the gentleman in our example here, if you tried, you know, seven or 10 different products, those might actually have changed the course of your disease in a particular way that would make your result different from somebody who's trying a drug for the very first time.
Interesting.
So it's about getting clean data. Exactly, right? So what we're trying to do when we're doing a clinical trial is to get out all of the extraneous detail to really drill down to see, is this result coming because of the intervention? On the other hand, we have to take a step back and ask, what is the most important research question? That question might be, how can we get a drug that's going to work for patients for whom other drugs have failed? That's a different scientific question than, does this drug work? And so we might think in the context of oncology, you see this a lot, where there's different lines of therapy.
What determines the effectiveness of a drug in clinical trials?
Right. Your first line therapy fails and then you go to your second or third or even fourth line therapies. So when new oncology drugs are being studied, they're typically being studied for later line therapies right after others have failed. And then once they get approval for that indication.
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Chapters
8 chapters
1
What personal experience highlights the challenges of enrolling in clinical trials?
0:03–0:57
2
What are the eligibility criteria for clinical trial participants?
0:57–1:51
3
How do inclusion and exclusion criteria affect clinical trial outcomes?
1:51–2:59
4
What role does the FDA play in the clinical trial process?
2:59–4:02
5
What determines the effectiveness of a drug in clinical trials?
4:02–4:56
6
How do surrogate endpoints differ from clinical endpoints in trials?
4:56–5:47
7
What are the responsibilities of Institutional Review Boards (IRBs)?
5:47–6:37
8
How has political influence affected FDA drug approval processes?
6:37–22:45
Speakers
3 identifiedMore from Science Friday
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