Dr. Holly Fernandez Lynch

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.

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.

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.

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.

You can keep studying them so that they can kind of move up the list.