PUBLICDOMAINPICTURES, VERA KRATOCHVILGovernment health agencies are cracking down on sluggish reporting of clinical trial results. Last week (September 16), Health and Human Services (HHS) announced an expansion of an existing law, which will require the results of all but Phase 1 studies to be posted on clinicaltrials.gov within one year of the trial ending. Previously, only trials related to approved treatments were subject to the rule.
“I think a lot of major universities just miss the point that if you do an experiment on a person and get consent, you really have the obligation to make the results known,” Robert Califf, US Food and Drug Administration (FDA) commissioner, told Nature News. “This is fundamentally an ethical issue.”
Simultaneously, the National Institutes of Health (NIH) declared that all agency-funded trials will be required to follow HHS’s rules.
Although a federal law requiring transparent reporting of human clinical trial data has been in place since 2007, many study sponsors are noncompliant, and there are substantial loop-holes.
NIH Director Francis Collins said his agency might withhold funding if researchers don’t obey the rules. “We are serious about this,” Collins told STAT News. “It’s hard ...
