New Rules Aimed To Make Clinical Trials Safer, More Effective : Shots - Health News The aim is to make clinical trial data available to volunteers and scientists, even if a drug or therapy being tested turns out to be a failure. That could help identify serious side effects.
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HHS Issues New Rules To Open Up Data From Clinical Trials

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HHS Issues New Rules To Open Up Data From Clinical Trials

HHS Issues New Rules To Open Up Data From Clinical Trials

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KELLY MCEVERS, HOST:

Millions of Americans volunteer to be human guinea pigs. They offer to test new drugs, devices, even new diets, in the name of advancing medicine. And researchers who run medical trials are supposed to be clear about what they're doing, and they're supposed to share their results. They don't always do these things. So today, the federal government announced new rules to address this problem. NPR's Richard Harris reports.

RICHARD HARRIS, BYLINE: The rules involve human studies known as clinical trials, which are typically tests of drugs or medical devices on volunteers.

FRANCIS COLLINS: Clinical trials are how we find out what works and what doesn't work and make advances in medicine.

HARRIS: Francis Collins heads the National Institutes of Health, which, in addition to industry, funds many of these studies. In 2007, the government established rules requiring that, in many instances, researchers need to disclose the existence, design and results of these experiments. But last year, Dr. Monique Anderson and colleagues at the Duke University Medical School reviewed clinical trials registered on a government website, and they were startled to see how few experiments reported their results on time.

DR. MONIQUE ANDERSON: Legal reporting was really low. It was 13.4 percent overall for the mandatory 12 months.

HARRIS: More scientists reported results late. But still, many didn't comply with the law. Anderson and her colleagues struggled to figure out which studies fell under the rule to begin with.

ANDERSON: It's actually really hard.

HARRIS: She's glimpsed at the new rules and thinks they will be much easier to interpret. They will also cover more areas of research. For the first time, companies will have to report drug and device research even if their products don't end up on the market. Also, NIH-funded researchers will need to register studies that involve behavioral research, for example, studies that compare one diet with another for disease prevention. Again, Francis Collins.

COLLINS: You randomize people to one dietary intervention or another, and then you look to see what worked, we'd want to know the results of that as soon as possible. Right now, it wasn't clear that those were included. We have made it very clear today that they are.

HARRIS: One common problem is that scientists don't report their results if the drug or other intervention doesn't work out. But Dr. Collins says that information can be just as important. And if other scientists don't know something has been tried and failed, they might get a grant and try to find out for themselves.

COLLINS: We are very stressed for resources. And the idea that we might end up supporting a trial for something where it's already been tested and found not to be successful - that's a waste of resources.

HARRIS: When these studies are done as part of the FDA approval process, companies that violate the disclosure rules can face fines of $10,000 a day. But the FDA has not levied those fines and doesn't have the budget to expand its enforcement. Even so, FDA Commissioner Rob Califf is optimistic.

ROBERT CALIFF: Yeah, I have to say I really believe that it won't take much to get people to comply with this once they realize how serious this is.

HARRIS: And Collins says the NIH will up its game by warning a university that it could lose funding for future clinical trials if it's not complying with the new rules.

COLLINS: Imagine if you get that note and you're the president of Harvard, it's probably going to get your attention.

HARRIS: The rules don't look back at the many studies that are still out of compliance, but they will apply to every covered new clinical trial starting next January. Richard Harris, NPR News.

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