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People dealing with serious diseases can turn to a government database of experimental treatments. It's called clinicaltrials.gov, and it get nearly 60,000 visits a day. Medical researchers have a year to report the results of many of these experiments. But a new study finds that deadline is being widely ignored, and this has very human consequences as NPR's Richard Harris reports.
RICHARD HARRIS, BYLINE: In 2009, a nine-year-old boy named Glenn Lightner was diagnosed with a rare brain cancer.
LARRY LIGHTNER: Like every other parent, we know nothing about cancer at the time. So we're just following whatever the oncologist is telling us to do.
HARRIS: Larry Lightner from Long Valley, N.J., says Glenn got radiation treatment, which worked for a while. But he says the radiation treatment itself had a serious side-effect.
LIGHTNER: It developed a second cancer, which was far more aggressive than the first cancer. One of the oncologists at NYU suggested that we look into clinical trials, because they knew that they had nothing to cure this cancer with.
HARRIS: Lightner is a transportation manager, not a scientist, but he dived headlong into the government's catalog of experimental treatments, clinicaltrials.gov. He says he spent four hours a night every night looking for something that could help Glenn.
LIGHTNER: Every time I clicked on the results tab, it always said no results posted - night after night, year after year.
HARRIS: He wasn't simply unlucky. Though a 2007 law requires scientists to post the results of many studies within a year, a new study finds that many ignore that requirement.
MONIQUE ANDERSON: We were really surprised to find that very few people are following the law.
HARRIS: Monique Anderson at Duke University is first author on a study in the New England Journal of Medicine. Overall she found just 13 percent of the studies reported results by their one-year deadline. Compliance improved a bit to about one-third after five years.
ANDERSON: We know that for industry in particular, about 50 percent of the trials that did not report had a legal reason to not report.
HARRIS: Pharmaceutical companies can sit on their data at times to preserve a competitive advantage if they're inclined to develop a new drug.
ANDERSON: That is not the case for NIH and academia, who are just lagging.
HARRIS: Even counting the late entries and allowable exceptions, only about 50 percent of taxpayer-funded research has been reported back to the taxpayers on clinicaltrials.gov, according to the study. Dr. Anderson says this is a practical issue for people looking for studies, but also an ethical issue.
ANDERSON: Any patient who participates in clinical research should expect to see that their participation is going to be used effectively.
HARRIS: That means making the results readily available. As it happens, Duke University is considered a good example of what a university needs to do to comply with the law.
MARK STACY: It was extremely difficult.
HARRIS: Dr. Mark Stacy is vice dean for clinical research at Duke. He says the University had a team working on this for months and has kept two full-time staffers to parse the complicated rules and to remind and cajole the scientists to fill out the forms.
STACY: These are very busy people, and this represents a new step in workflow. And we don't always do well when we add a new step in workflow.
HARRIS: One worry is that the folks who aren't complying aren't simply busy. Mark Helfand at Oregon Health and Science University says scientists are more likely to report good news and ignore bad news, which skews the scientific record. What's more, Dr. Helfand has found that what's published doesn't necessarily match what's reported in clinicaltrials.gov.
MARK HELFAND: In a significant proportion of cases, the results on clinicaltrials.gov were reported more thoroughly than the results in corresponding journal articles.
HARRIS: Serious side-effects in particular were more likely to be represented online than in a published study. Universities who don't report their studies on time can face fines of $10,000 a day, and they can even lose federal research grants. But even though the law was passed in 2007, the government is still trying to finalize the precise rules. And in the meantime, nobody's getting punished. Larry Lightner, whose son had brain cancer, is rallying patient advocates to support disclosure rules with no exceptions.
LIGHTNER: There's a lot of parents who have asked for the results of a clinical trial that their child was in, and they will not get an answer. They refuse to give them the results.
HARRIS: And as for his son Glenn...
LIGHTNER: He died December 12, 2012. And he was 14.
HARRIS: Richard Harris, NPR News.
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