Federal judge rules clinical trial sponsors must publish a decade’s worth of missing data
WASHINGTON — For years, government research agencies have misinterpreted a law that requires them to collect and post clinical trial data, a federal judge ruled this week, leaving behind a 10-year gap in data that now must be made publicly available.
Now, potentially hundreds of universities, drug companies, and medical device manufacturers are on the hook to release previously unpublished data. The ruling affects trials conducted for as-yet-unapproved drugs and devices in that 10-year stretch, according to a lawyer for the plaintiffs — meaning hundreds or even upwards of 1,000 noncompliant trials would be forced to post data.
