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New drugs could get a different test

Helen Palmer Jul 10, 2006

KAI RYSSDAL: It might sound procedural, just more bureaucratic mumbo-jumbo, something about the Food and Drug Administration changing some rules. But think for a second about everything you take for your migraine or joint pain, high cholesterol or something more serious, and then the story becomes more interesting.One of the FDA’s top regulators said today the agency’s open to the idea of redesigning clinical drug trials, adopting them as they’re underway.Helen Palmer is at the Marketplace Health Desk at WGBH. Hello, Helen.

HELEN PALMER: Hi there. How are you doing?

RYSSDAL: I’m well. This adaptive testing, what does that mean?

PALMER: Well basically at the moment how clinical trials work is we rely on the gold standard, which is these placebo-controlled trials where everything’s double blind, nobody knows who’s getting what therapy. And so you don’t know until the end of the trial, say two years, three years, whether a drug is actually working and you can actually then analyze the data.

Adaptive drug trials would allow you to change along the way. When you see, for instance, that certain groups are responding very well. They’d enable you to bring in more people who are responding very well and get a more robust response.

RYSSDAL: But these blind tests have been working pretty well for the FDA for these many years. Why change now?

PALMER: There’s a lot about it that’s very exciting. It could potentially really speed up getting drugs to market. We got better data now because of the result of the cracking of the human genome. We can actually run drugs against various different genes and find out what works and what doesn’t. So you can speed up a lot of the early stages of drug development. But there hasn’t been any way to speed up clinical trials. This could actually speed up clinical trials.

RYSSDAL: Granted it might make things faster, but is that necessarily better? Don’t we want to have tests take time so we can really suss out whether they work or perhaps don’t?

PALMER: Well, obviously, this is the point. That once you start adapting trials along the way, you potentially bring in biases. You know, if you see, wow, it’s working really well in, say, young women with lung cancer then you can particularly get more of these women and target them and maybe bias your results.

So there are a lot of concerns that people have. Of course, there is another one. People suggest that the drug companies could manipulate the data, that they could possibly skew the data and could fudge the data. Not that that’s necessarily something that they would do, but it would be harder to see if they were doing this.

RYSSDAL: Obviously, faster trials means faster possible approval, which means possibly that the drug companies could get these very expensive to manufacture medicines to market faster and recoup their investment. Drug companies are in favor, one has to imagine, of adaptive testing?

PALMER: Drug companies are a little hesitant. They can see the advantages, but they can also see the disadvantages. I mean, it’s a great advantage to them if, for instance, we pick up danger side effects earlier. And they’re not, say, giving Vioxx to heart patients who will suffer as a result of it. So that kind of result would be great. And that, obviously, they’re really in favor of.

They’re really in favor of speeding up clinical trials and maybe having more targeted clinical trials that cost less. But equally, they’re not as robust as the double blind placebo trial that we’ve all relied on – the gold standard. And they’re never going to be quite trusted as well until we’ve gotten more used to them. But we have a couple of years really.

There’s a big conference in the fall that’s going to discuss this. And then they’re going to write all the regulations for this. And the most important thing is that there’s going to have to be independent people writing the rules here. Independent people verifying all these trials and actually verifying all the changes. And unless that happens then nobody will be terribly happy.

RYSSDAL: Helen Palmer from the Marketplace Health Desk at WGBH in Boston. Thanks, Helen.

PALMER: You’re welcome.

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