FLICKR, CANDY
Estimates of under-reported clinical trial data are overblown, according to the US Food and Drug Administration and the National Institutes of Health. The agencies are responding to questions from Congress spurred by a recent British Medical Journal paper, which found that only 22 percent of trial sponsors in 2009 followed the law and reported trial conclusions within a year of trial completion, reported Nature.
The FDA argues that the BMJ study was flawed by including some trials completed before the 2007 law took effect, failing to exclude some exempted trials or trials of unapproved products, and including trials whose data had not yet been checked by the NIH. ClinicalTrials.gov, the public database the study’s authors drew on, also does not make clear if a trial’s ...
